AzTrials
AzTrials

Multiple MyelomaPhase 1DREAMM12NCT04398745

A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function

A Phase 1 study testing Belantamab mafodotin in people with Multiple Myeloma, run by GlaxoSmithKline at 4 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and the majority of MM participants is either at risk or already has renal dysfunction at initial diagnosis. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesin 2 countries
Study dates
9 Oct 2020to 11 Mar 2027
Phase
Phase 1
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

  • Participants are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
  • Male and/or female participants must be 18 years of age or older, at the time of signing the informed consent. In Republic of Korea, participants must be 19 years of age or older at the time of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Participants with histologically or cytologically confirmed diagnosis of MM, as defined in International Myeloma Working Group criteria: 1. Has undergone autologous stem cell transplant (SCT) or is considered transplant-ineligible; 2. Has failed at least 2 prior lines of anti-myeloma treatments, including an immunomodulatory drug (example [e.g.], lenalidomide or pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib). In Republic of Korea, participants should also have relapsed or refractory disease after treatment with an anti-CD38 antibody, if accessible to patients, or other suitable local standard of care.
  • Participants have measurable disease with at least one of the following: Serum M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per liter [g/L]); Urine M-protein >=200 milligrams (mg) per 24 hours (mg/24 h); and Serum free light chain (FLC) assay: Involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 milligrams per liter [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: 1. Transplant was >100 days prior to study enrollment, 2. No active infection(s), and 3. Participant meets the remainder of the eligibility criteria outlined in this protocol.
Show all 10Show fewer
  • Participants with adequate organ system functions as defined follows: Absolute neutrophil count >=1.0 x 10^9 per liter (/L); Hemoglobin >=7.0 g/dL or 4.9 millimoles per liter (mmol/L); Platelets >= 50 x 10^9/L; Total bilirubin <=1.5 x Upper limit of normal (ULN) (Isolated bilirubin >=1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]); Alanine aminotransferase <=2.5 x ULN; iGFR, Group 1: normal/ mildly impaired >=60milliliter per minute (mL/min); Group 2: severe 15-29 mL/min; Group 3: ESRD (not on dialysis) <15 mL/min; Group 4: ESRD (on dialysis) <15 mL/min; and left ventricular ejection fraction by echocardiograms >=40%.
  • Main additional inclusion criteria in Group 1 (matched control participants): Matched to at least one severely renal impaired participant by Baseline body weight (+/-20%) and Baseline albumin levels (+/-10%).
  • Female participants: Contraceptive use by women should be consistent with local regulations regarding the 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 childbearing 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 study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on Cycle 1 Day 1 and agree to use highly effective contraception during the study and for 4 months after the last dose of study medication. 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.
  • Male participants: Contraceptive use by men 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 from the time of first dose of study until 6 months after the last dose of study treatment to allow for clearance of any altered sperm: 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 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 as when having sexual intercourse with a WOCBP (including pregnant females).

Who cannot join

  • Participants with active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein and skin changes), Waldenstroem Macroglobulinemia
  • Participants had a prior allogeneic stem cell transplant. . Participants who have undergone a syngeneic bone marrow transplant will be allowed only if there is no history of, or no currently active graft-versus-host-diseases (GvHD).
  • Participant has received an investigational drug within 14 days or 5 half-lives whichever is shorter, preceding the first dose of study drug. This includes prior treatment with a monoclonal antibody. The only exception is emergency use of a short course of systemic corticosteroids (equivalent to, or less than: dexamethasone 40 milligrams per day [mg/day] for a maximum of 4 days) before treatment.
  • Prior belantamab mafodotin therapy.
  • Participant has received a strong Organic-anion transporting polypeptide inhibitor within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug.
  • Systemic active infection requiring treatment.
Show all 21Show fewer
  • Any unresolved toxicity >=Grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to Grade 2.
  • Plasmapheresis within 7 days prior to the first dose of study drug. Screening laboratory values must be performed after last plasmapheresis.
  • Any major surgery within the last 4 weeks prior to Day 1 of Screening.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except renal impairment) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Evidence of active mucosal or internal bleeding.
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. (Stable chronic liver disease [(including Gilbert's syndrome or asymptomatic gallstones]) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria)
  • Participants with previous or concurrent malignancies other than MM are excluded, unless the prior 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. (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 untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as second degree (Mobitz Type II) or third degree atrioventricular block; History of myocardial infarction (within prior 18 months), 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 and 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.
  • Known human immunodeficiency virus infection, unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/mL prior to first dose; CD4+ T-cell (CD4+) counts ≥350 cells/ L and no history of AIDS-defining opportunistic infections within the last 12 months
  • Participants with Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undectectable at the time of screening; If HbsAg+ at screening or <=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment. Participants with cirrhosis are excluded.
  • Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid test result at Screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: RNA test negative and Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks prior to first dose.
  • Participants with renal impairment due to hepatic disease (hepatorenal syndrome).
  • Current corneal epithelial disease except for mild punctuate keratopathy.
  • Participant is a woman who is pregnant or breastfeeding.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Greece2 sites

  • GSK Investigational Site

    Athens, 10676

  • GSK Investigational Site

    Athens, 11528

Other trials in Greece

South Korea2 sites

  • GSK Investigational Site

    Busan, 49241

  • GSK Investigational Site

    Seoul, 06591

Other trials in South Korea

About this study

Official title: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) Who Have Normal and Varying Degrees of Impaired Renal Function (DREAMM 12)

Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and the majority of MM participants is either at risk or already has renal dysfunction at initial diagnosis. The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with RRMM, who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation ) and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal/mildly impaired renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD), where participants are either not undergoing or require hemodialysis. Participants will be administered belantamab mafodotin at a dose of 2.5 milligram per kilogram (mg/kg) intravenously once in three weeks (Q3W) dosing in Part 1. Based on the Part 1 Safety/Pharmacokinetic (PK) data, Part 2 participants will be administered the dose of either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose). Participants will be treated with belantamab mafodotin monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, follow-up phase and a post analysis continued treatment (PACT) phase . The total duration of the study is approximately up to 48 months.

Being tested
Belantamab mafodotin
Keywords
DREAMM12, End-stage renal disease, Normal renal function, Renal impairment, Relapsed and/or refractory multiple myeloma, Belantamab mafodotin
Medical subject headings
Multiple Myeloma, Kidney Failure, Chronic, Renal Insufficiency

What participants receive

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

  • Belantamab mafodotinDrug

    Also called GSK2857916

    Belantamab mafodotin will be provided as lyophilized powder which will be available as 100 milligrams per vial (mg/vial) in single-use vial for reconstitution. Lyophilized belantamab mafodotin will reconstituted using water for injection, dilute with normal 0.9 % saline before use.

Study groups in NCT04398745
Study groupRoleWhat they receive
Part 1: Participants with normal/mild impaired renal functionExperimentalParticipants with normal or mildly impaired renal function (Normal: individual glomerular filtration rate [iGFR]: >=90 milliliter per minute; Mild impairment: iGFR: 60-89 mL/min will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Receives: Drug: Belantamab mafodotin
Part 1: Participants with severe renal impairmentExperimentalParticipants with severely impaired renal function (iGFR: 15-29 mL/min) will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Receives: Drug: Belantamab mafodotin
Part 2: Participants with ESRD (not on dialysis)ExperimentalParticipants with ESRD (iGFR: <15 mL/min) not on dialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, the dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.
Receives: Drug: Belantamab mafodotin
Part 2: Participants with ESRD (on hemodialysis)ExperimentalParticipants with ESRD (iGFR: <15 mL/min) on hemodialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21-day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, the dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.
Receives: Drug: Belantamab mafodotin

What is being measured

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

  1. Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  2. Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  3. Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.

    Measured: End of infusion on C1D1 and C3D1

  4. Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  5. Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  6. Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  7. Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)

  8. Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  9. Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  10. Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.

    Measured: End of infusion on C1D1 and C3D1

  11. Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  12. Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin total antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  13. Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  14. Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)

  15. Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  16. Part 1: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, and D15; Anytime on C3 D4, D8, and D15

  17. Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.

    Measured: End of infusion on C1D1 and C3D1

  18. Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  19. Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  20. Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  21. Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  22. Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  23. Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC.

    Measured: End of infusion on C1D1 and C3D1

  24. Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  25. Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  26. Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  27. Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)

    Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)

  28. Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  29. Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  30. Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody.

    Measured: End of infusion on C1D1 and C3D1

  31. Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  32. Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  33. Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  34. Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)

    Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)

  35. Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  36. Part 2: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, and D15; Anytime on C3 D4, D8, and D15

  37. Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF.

    Measured: End of infusion on C1D1 and C3D1

  38. Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  39. Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

  40. Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

    Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

    Measured: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

Secondary outcomes (7)

  1. Part 1 and Part 2: Change From Baseline (CFB) 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. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

    Measured: Baseline (Day 1) and up to approx. 236 weeks

  2. Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate

    Heart 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 approx. 236 weeks

  3. Part 1 and Part 2: Number of Participants With Adverse Events (AEs)

    An AE is defined as 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. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Measured: Up to approximately 236 weeks

  4. Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.

    Measured: Baseline (Day 1) and up to approx. 236 weeks

  5. Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.

    Measured: Baseline (Day 1) and up to approx. 236 weeks

  6. Part 1 and Part 2: Change From Baseline (CFB) in Weight

    Physical examination parameter weight was assessed. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline

    Measured: Baseline (Day 1) and up to approx. 236 weeks

  7. Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

    Urine samples were collected to assess occult blood and protein in urine by dipstick method. Data is presented as "No Change/Decreased" and "Any Increase" that includes Increase to TRACE, Increase to 1+, Increase to 2+ and Increase to 3+ indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.

    Measured: Baseline (Day 1) and up to approx. 236 weeks

Timeline

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

  1. First posted21 May 2020
  2. Study start9 Oct 2020
  3. Primary completion21 Apr 2025
  4. Study completion11 Mar 2027 (estimated)

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04398745
Sponsor's protocol ID
209626
Acronym
DREAMM12
Status last verified
Jun 2026
First submitted
19 May 2020
Last updated
1 Jul 2026
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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Belantamab mafodotin in people with Multiple Myeloma, run by GlaxoSmithKline at 4 sites in 2 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 10 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Greece, South Korea. 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 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.

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 1 Jul 2026). 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?

Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC)) (time frame: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.). The study lists 40 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 NCT04398745.

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 1 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in