AzTrials
AzTrials

Multiple MyelomaPhase 1/2DREAMM 6NCT03544281

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

A Phase 1/2 study testing Belantamab mafodotin, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline at 26 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Treatment A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Treatment B)] in participants with RRMM, i.e., those who have… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Belantamab mafodotin, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
26 sitesin 5 countries
Study dates
20 Sep 2018to 28 Feb 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent.
  • Male or female, 18 years or older (at the time consent is obtained).
  • Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B.
  • Have undergone stem cell transplant (SCT), or are considered transplant ineligible.
  • Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy.
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  • Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
  • Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria.
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be Grade <= 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm.
  • Adequate organ system functions as defined by the laboratory assessments.
  • The contraceptions used by female participants be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • WOCBP Participants Assigned to Arm A:
  • Due to lenalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective; beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of <1% per year) for a further 3 months, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period: Two negative pregnancy tests must be obtained prior to initiating lenalidomide therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing lenalidomide therapy.
  • WOCBP Participants Assigned to Arm B
  • WOCBP assigned to Arm B must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1 and agree to use effective contraception during the study and for 4 months after the last dose of belantamab mafodotin or 7 months from the last dose of bortezomib, whichever is longer.
  • Male participants using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male participants are eligible to participate if they agree to the following:
  • Arm A: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin 4 weeks after the last dose of lenalidomide, whichever is longer, to allow for clearance of any altered sperm.
  • Arm B: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin or 4 months from the last dose of bortezomib (whichever is the longer) to allow for clearance of any altered sperm.
  • Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below.
  • Agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse. Male participants should also use a condom with pregnant females. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom.

Who cannot join

  • Systemic anti-myeloma therapy (including systemic steroids) within <=14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
  • Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
  • Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
  • Prior allogenic stem cell transplant. Note: Participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD).
  • Evidence of active mucosal or internal bleeding.
  • Any major surgery within the last four weeks.
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  • Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
  • Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
  • Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Pregnant or lactating female.
  • Active infection requiring treatment.
  • Known Human immunodeficiency virus (HIV) infection.
  • Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
  • Current corneal disease except for mild punctuate keratopathy.
  • Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
  • Current corneal disease except for mild punctute keratopathy.
  • Participants Assigned to Treatment A (belantamab mafodotin plus Len/Dex): Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
  • Participants Assigned to Treatment B (belantamab mafodotin plus Bor/Dex): Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.

Trial locations and contacts

26 sites in 5 countries.

26 sites in 5 countries

United States12 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30322-4200

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Dallas, Texas, 75251

  • GSK Investigational Site

    Goodyear, Arizona, 85338

  • GSK Investigational Site

    Grand Island, Nebraska, 68803

  • GSK Investigational Site

    Greer, South Carolina, 29650

  • GSK Investigational Site

    Hackensack, New Jersey, 07601

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    New York, New York, 10022

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    The Bronx, New York, 10467

Other trials in United States

Australia7 sites

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Melbourne, Victoria, 3000

  • GSK Investigational Site

    Melbourne, Victoria, 3004

  • GSK Investigational Site

    Murdoch, Western Australia, 6150

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Wollongong, New South Wales, 2500

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

Spain4 sites

  • GSK Investigational Site

    Barcelona, 8035

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Salamanca, 37007

Other trials in Spain

United Kingdom2 sites

  • GSK Investigational Site

    London, W1T 7HA

  • GSK Investigational Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Canada1 site

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Official title: A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6

This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Treatment A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Treatment B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy.

Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.

Being tested
Belantamab mafodotin, Lenalidomide, Dexamethasone, Bortezomib
Keywords
Relapsed / Refractory Multiple Myeloma, Antibody-Drug Conjugate, belantamab mafodotin, Combination therapy, Belamaf
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Belantamab mafodotinDrug

    Selected doses of belantamab mafodotin will be administered as an infusion.

  • LenalidomideDrug

    Lenalidomide will be administered as 25 or 10 mg,orally, with belantamab mafodotin and dexamethasone.

  • DexamethasoneDrug

    Dexamethasone will be administered as 20 or 40 mg, orally with belantamab mafodotin.

  • BortezomibDrug

    Bortezomib will be administered as 1.3 mg/m^2, as SC or IV, with belantamab mafodotin and dexamethasone.

Study groups in NCT03544281
Study groupRoleWhat they receive
Arm A: Belantamab mafodotin+lenalidomide +dexamethasoneExperimentalParticipants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion. SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle. STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, \& 22 of each cycle.
Receives: Drug: Belantamab mafodotin; Drug: Lenalidomide; Drug: Dexamethasone
Arm B: Belantamab mafodotin+bortezomib+dexamethasoneExperimentalParticipants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 \& 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 \& 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 \& so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, \& so on). Bortezomib will be administered at 1.3 mg/m^2 SC/IV on Days 1,4,8, \& 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, \& 12 of every 21-day cycle.
Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A

    DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting >48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia <25,000/mm^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist >48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment).

    Measured: Up to 28 days

  2. Number of Participants With DLTs, Treatment B

    DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting >48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia <25,000/mm^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist >48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment).

    Measured: Up to 21 days

  3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).

    Measured: Up to approximately 4.5 years

  4. Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)

    12-lead electrocardiogram (ECGs) were obtained using an automated ECG machine that automatically calculated the QTcF intervals. QTc values are categorized into the clinical concern ranges which are specific to changes in QTc: 31-60 milliseconds (msec), and >60 msec, and >530msec. An increase is defined relative to Baseline. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Data of number of participants with worst-case increase post baseline is presented.

    Measured: Up to approximately 4.5 years

  5. Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

    Blood samples were collected for analysis of following hematology parameters: Hemoglobin (hemoglobin increased and anemia), Lymphocytes (lymphocyte count increased and lymphocyte count decreased), Neutrophils, Platelets and Leukocytes (leukocytosis and white blood cells decreased). The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  6. Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

    Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, erythrocytes and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  7. Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

    Blood samples were collected for analysis of following clinical chemistry parameters: Hyperglycemia, Hypoglycemia, Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase, (AST), Bilirubin, Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Hyperkalemia, Hypokalemia, Hypermagnesemia, Hypomagnesemia, Phosphate, Hypernatremia, Hyponatremia, Urate, Hypercalcemia and Hypocalcemia. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  8. Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters

    Blood samples were collected for analysis of following clinical chemistry parameters: Direct Bilirubin (DB), Calcium, Chloride, Carbon Dioxide (CO2), lactate dehydrogenase (LDH) and Protein. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  9. Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein

    Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased and increase to trace, 1+, 2+, 3+, >3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  10. Change From Baseline in Urine Potential of Hydrogen (pH)

    Urine samples were collected to analyze urine pH levels. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  11. Change From Baseline in Urine Specific Gravity

    Urine samples were collected to analyze urine specific gravity using dipstick method. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  12. Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

    Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  13. Change From Baseline in Vital Signs : Pulse Rate

    Pulse rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  14. Change From Baseline in Vital Signs : Temperature

    Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  15. Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)

    ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR: negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasmacytomas in the bone marrow; sCR: stringent complete response, CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR >= 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 h. Confidence intervals were based on the exact method.

    Measured: Up to approximately 4.5 years

Secondary outcomes (69)

  1. Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A

    Blood samples were collected at indicated timepoints for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8

  2. Area Under the Concentration Time Curve (AUC) From Time 0 to 504 Hours (0-504h) for Belantamab Mafodotin ADC, Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21

  3. AUC (0-672h) for Belantamab Mafodotin ADC, Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28

  4. Time to Reach Maximum Observed Concentration (Tmax) for Belantamab Mafodotin ADC, Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  5. Time of Last Observed Quantifiable Concentration (Tlast) for Belantamab Mafodotin ADC, Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28

  6. Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8

  7. Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and Day 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8

  8. Cmax for Belantamab Mafodotin ADC, Treatment B

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  9. AUC (0-504h) for Belantamab Mafodotin ADC, Treatment B

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

  10. AUC (0-1008h) for Belantamab Mafodotin ADC, Treatment B

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008h) was derived only for Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex, Belantamab mafodotin 2.5 mg/kg StepDown STRETCH + Bor/Dex and Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex cohorts.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7

  11. Tmax for Belantamab Mafodotin ADC, Treatment B

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  12. Tlast for Belantamab Mafodotin ADC, Treatment B

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

    Measured: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 5 Day 1

  13. Ctrough for Belantamab Mafodotin ADC, Treatment B

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

  14. C-EOI for Belantamab Mafodotin ADC, Treatment B

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8

  15. Cmax for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  16. AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21

  17. AUC (0-672h) for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28

  18. AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7

  19. AUC(0-1344h) for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1344) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 7 Day 7

  20. Tmax for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  21. Tlast for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28; pre-dose Cycle 3 Day 8

  22. Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

  23. C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A

    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

  24. Cmax for Belantamab Mafodotin (Total Antibody) Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  25. AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

  26. AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008h) was derived only for Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex, Belantamab mafodotin 2.5 mg/kg StepDown STRETCH + Bor/Dex and Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex cohorts.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7

  27. Tmax for Belantamab Mafodotin (Total Antibody), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  28. Tlast for Belantamab Mafodotin (Total Antibody), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

    Measured: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 9 Day 1

  29. Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

  30. C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

  31. Cmax for Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  32. AUC (0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, and Cycle 1 Day 8

  33. AUC (0-336h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC (0-336h) was derived only for the Belantamab mafodotin 2.5mg/kg + Len/Dex SPLIT cohort.

    Measured: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 14

  34. Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  35. Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 1 Day 15

  36. C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

  37. Cmax for Belantamab Mafodotin (Cys-mcMMAF) Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  38. AUC(0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4; and Cycle 1 Day 7

  39. Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

  40. Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

    Measured: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 1

  41. C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8

  42. Cmax for Lenalidomide (25 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

  43. AUC(0-24h) for Lenalidomide (25 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

  44. AUC (0-4h) for Lenalidomide (25 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose

  45. Tmax for Lenalidomide (25 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

  46. Tlast for Lenalidomide (25 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post dose on Cycle 1 Day 1

  47. Cmax for Lenalidomide (10 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

  48. AUC(0-24h) for Lenalidomide (10 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

  49. AUC (0-4h) for Lenalidomide (10 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose

  50. Tmax for Lenalidomide (10 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

  51. Tlast for Lenalidomide (10 mg), Treatment A

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post dose on Cycle 1 Day 1

  52. Cmax for Bortezomib, Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, 0.5, 1, 2, 4 and 24 Hours Post-Dose on Cycle 1 Day 1

  53. AUC (0-72h) for Bortezomib, Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

  54. AUC (0-t) for Bortezomib, Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

  55. Tmax for Bortezomib, Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

  56. Tlast for Bortezomib, Treatment B

    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

    Measured: Pre-Dose, Post dose on Cycle 1 Day 3

  57. Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

    Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin using validated immunoassays.

    Measured: Up to approximately 4.5 years (End of Treatment [EoT])

  58. Titers of ADAs Against Belantamab Mafodotin

    Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin using validated immunoassays. Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titers of anti-drug antibodies against belantamab mafodotin is presented.

    Measured: Up to approximately 4.5 years

  59. Change From Baseline in Ocular Surface Disease Index (OSDI) Total Scores

    The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. OSDI consist of three subscales (ocular symptoms: item 1-3; visual related function: item 4-9; environmental triggers: item 10-12). Each item will be graded on a scale of 0 (none of the time or lower disability) to 4 (all of the time or greater disability) with total scores ranging from 0 (no disability) to 100 (complete disability). The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). Higher scores indicated greater disability. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  60. Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores

    The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the patient's perception of vision-related functioning and vision-related quality of life. Items were coded to a 0 to 100 scale and were averaged to calculate domains. The composite score ranges from 0 (worst score) to 100 (best score), with higher scores indicating better vision-related functioning. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  61. Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE like Anxious, Blurred Vision, Chills, Concentration, Constipation, Cough, Decreased Appetite, Discouraged, Dizziness, Fatigue, Heart Palpitations, Insomnia, Memory, Mouth/Throat Sores, Nausea, Nosebleed, Numbness \& Tingling, Pain, Ringing In Ears, Shortness Of Breath, Vomiting and Watery Eyes. Number of participants with symptomatic AEs measured by PRO-CTCAEs are presented.

    Measured: Up to approximately 4.5 years

  62. Number of Participants With AEs of Special Interest (AESI)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI for belantamab mafodotin (corneal events, thrombocytopenia and infusion related reactions) are presented.

    Measured: Up to approximately 4.5 years

  63. Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores

    BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline <0.12 logMAR score; a possible worsened vision was defined as a change from baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from baseline >=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  64. Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results

    BCVA score was assessed individually for better seeing eye and worse seeing eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change post baseline categories are presented for better seeing eye and worse seeing eye. BCVA test scores by Snellen results were categorized as improved BCVA, <= 2 lines decline in visual acuity from baseline, >= 3 lines decline in visual acuity from baseline. Number of lines change from baseline was defined as the following: Improved BCVA equates to a negative change in logMAR from baseline BCVA. <= 2 lines decline in visual acuity equates to logMAR change from baseline ≤0.37. >= 3 lines decline in visual acuity equates to logMAR change from baseline ≥0.38. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  65. Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception

    Number of participants with a Decline in BCVA to 'Light Perception (LP)' or 'No Light Perception (NLP)' due to a Corneal Event Anytime Post-Baseline are presented. BCVA score was assessed individually for each eye (Left and Right). Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Number of participants analyzed were who have any post-baseline BCVA score, where the Visual Acuity is due to corneal findings.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  66. Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)

    Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial haze were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  67. Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings

    Participants with worse grade punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  68. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score

    The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])

  69. Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score

    The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2018
  2. Study start20 Sep 2018
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03544281
Sponsor's protocol ID
207497
Other IDs
2017-004689-93, 2017
Acronym
DREAMM 6
Status last verified
Feb 2025
First submitted
30 Apr 2018
Last updated
18 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Belantamab mafodotin, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline at 26 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Australia, Spain, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A (time frame: Up to 28 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03544281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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DREAMM 6 Clinical Trial NCT03544281 | AzTrials