Multiple MyelomaPhase 3DREAMM 8NCT04484623
Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
A Phase 3 study testing Belantamab mafodotin, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline at 122 sites in 18 countries.
Trial summary
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM). 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, Pomalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 122 sitesin 18 countries
- Study dates
- 1 Oct 2020to 25 Jun 2029
- Phase
- Phase 3
- 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.
- Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
- Must have at least 1 aspect of measurable disease defined as one of the following;
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- Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
- Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]), or
- Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike.
- Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
- All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
- Adequate organ system functions as mentioned in the protocol.
- Male and female participants agree to abide by protocol-defined contraceptive requirements.
Who cannot join
- Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
- Prior allogeneic SCT.
- Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
- Plasmapheresis within 7 days prior to the first dose of study drug.
- Received prior treatment with or intolerant to pomalidomide.
- Received prior Beta cell maturation antigen (BCMA) targeted therapy.
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- Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly).
- Evidence of cardiovascular risk including any of the following;
- Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
- Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- Uncontrolled hypertension.
- Any major surgery within the last 4 weeks.
- Previous or concurrent invasive malignancy other than multiple myeloma, except:
- The disease must be considered medically stable for at least 2 years; or
- The participant must not be receiving active therapy, other than hormonal therapy for this disease.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
- Evidence of active mucosal or internal bleeding.
- Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
- Active infection requiring treatment.
- Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
- Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
- Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy.
- Active or history of venous and arterial thromboembolism within the past 3 months.
- Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
- Current corneal disease except for mild punctate keratopathy.
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
- Pregnant or lactating female.
Trial locations and contacts
122 sites in 18 countries.
122 sites in 18 countries
Spain14 sites
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 8035
GSK Investigational Site
Gijón, 33204
GSK Investigational Site
L'Hospitalet de Llobrega, 08908
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28027
GSK Investigational Site
MOstoles Madrid, 28933
GSK Investigational Site
Murcia, 30008
GSK Investigational Site
Palma de Mallorca, 07120
GSK Investigational Site
PamplonaNavarra, 31008
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
GSK Investigational Site
Salamanca, 37007
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Valencia, 46026
Japan13 sites
GSK Investigational Site
Aichi, 467-8602
GSK Investigational Site
Chiba, 277-8567
GSK Investigational Site
Chiba, 296-8602
GSK Investigational Site
Ehime, 790-8524
GSK Investigational Site
Fukushima, 960-1295
GSK Investigational Site
Gunma, 371-8511
GSK Investigational Site
Gunma, 377-0280
GSK Investigational Site
Hokkaido, 060-8648
GSK Investigational Site
Numakunai, 028-3695
GSK Investigational Site
Okayama, 701-1192
GSK Investigational Site
Osaka, 565-0871
GSK Investigational Site
Tottori, 683-8504
GSK Investigational Site
Yamagata, 990-9585
China12 sites
GSK Investigational Site
Beijing, 100191
GSK Investigational Site
Beijing
GSK Investigational Site
Changchun, 130012
GSK Investigational Site
Changsha, 410013
GSK Investigational Site
Guangzhou, 510060
GSK Investigational Site
Hangzhou, 310003
GSK Investigational Site
Jiangsu, 221004
GSK Investigational Site
Nanchang, 330006
GSK Investigational Site
Shenyang, 110004
GSK Investigational Site
Shenzhen, 518029
GSK Investigational Site
Tianjin, 300020
GSK Investigational Site
Wuhan, 430022
Australia11 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Benowa, Queensland, 4217
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Fitzroy, Victoria, 3065
GSK Investigational Site
Garran, Australian Capital Territory, 2605
GSK Investigational Site
Gosford NSW, New South Wales, 2250
GSK Investigational Site
Heidelberg, Victoria, 3084
GSK Investigational Site
Malvern, Victoria, 3144
GSK Investigational Site
Nedlands, Western Australia, 6009
GSK Investigational Site
Port Macquarie, New South Wales, 2444
GSK Investigational Site
South Brisbane, Queensland, 4101
Russia8 sites
GSK Investigational Site
Moscow, 125101
GSK Investigational Site
Moscow, 125284
GSK Investigational Site
Novosibirsk, 630087
GSK Investigational Site
Saint Petersburg, 191024
GSK Investigational Site
Saint Petersburg, 194291
GSK Investigational Site
Saint Petersburg, 197341
GSK Investigational Site
Samara, 443099
GSK Investigational Site
Sochi, 354057
Turkey (Türkiye)8 sites
GSK Investigational Site
Ankara, 06100
GSK Investigational Site
Ankara, 6340
GSK Investigational Site
Ankara, 6560
GSK Investigational Site
Izmir, 35100
GSK Investigational Site
Izmir, 35330
GSK Investigational Site
Kocaeli, 41400
GSK Investigational Site
Mersin, 33343
GSK Investigational Site
Samsun, 55139
South Korea7 sites
GSK Investigational Site
Gyeonggi-do, 10408
GSK Investigational Site
Hwasun, 58128
GSK Investigational Site
Inchon, 21565
GSK Investigational Site
Seoul, 03080
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 06351
GSK Investigational Site
Seoul, 06591
Israel6 sites
GSK Investigational Site
Haifa, 3109601
GSK Investigational Site
Jerusalem, 91031
GSK Investigational Site
Kfar Saba, 4428164
GSK Investigational Site
Nahariya, 2633737
GSK Investigational Site
Petah Tikva, 4941492
GSK Investigational Site
Tel Aviv, 6423906
New Zealand6 sites
GSK Investigational Site
Auckland, 1023
GSK Investigational Site
Auckland, 2025
GSK Investigational Site
Dunedin, 9016
GSK Investigational Site
Hamilton, 3204
GSK Investigational Site
Takapuna Auckland, 622
GSK Investigational Site
Tauranga, 3143
United States5 sites
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Fort Myers, Florida, 33901
GSK Investigational Site
Kansas City, Missouri, 64132
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Tucson, Arizona, 85712
Greece5 sites
GSK Investigational Site
Athens, 10676
GSK Investigational Site
Athens, 115 25
GSK Investigational Site
Athens, 115 28
GSK Investigational Site
Ioannina, 45 500
GSK Investigational Site
Thessaloniki, 57010
Poland5 sites
GSK Investigational Site
Bydgoszcz, 85-168
GSK Investigational Site
Gdansk, 80-214
GSK Investigational Site
Krakow, 31-501
GSK Investigational Site
Lodz, 93-513
GSK Investigational Site
Wroclaw, 50-367
United Kingdom5 sites
GSK Investigational Site
London, W12 0HS
GSK Investigational Site
Plymouth, PL6 8D8
GSK Investigational Site
Southampton, SO16 6YD
GSK Investigational Site
Stoke-on-Trent, ST4 6QG
GSK Investigational Site
Sutton, SM2 5PT
Brazil4 sites
GSK Investigational Site
Curitiba, 01308-050
GSK Investigational Site
Joinville, 89201-260
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
GSK Investigational Site
São Paulo, 04537-081
Italy4 sites
GSK Investigational Site
Bologna, 40138
GSK Investigational Site
Milan, 20122
GSK Investigational Site
Pavia, 27100
GSK Investigational Site
Roma, 00161
Czechia3 sites
GSK Investigational Site
Brno, 62500
GSK Investigational Site
Hradec Králové, 50333
GSK Investigational Site
Prague, 12808
France3 sites
GSK Investigational Site
Marseille, 13273
GSK Investigational Site
Toulouse, 31059
GSK Investigational Site
Vanduvre-lEs-Nancy, 54511
Germany3 sites
GSK Investigational Site
Mainz, 55131
GSK Investigational Site
Tübingen, 72076
GSK Investigational Site
Würzburg, 97080
About this study
Official title: A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
- Conditions
- Multiple Myeloma
- Being tested
- Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
- Keywords
- Global Cohort, Belantamab Mafodotin, Relapsed/Refractory Multiple Myeloma, Pomalidomide, Dexamethasone, Bortezomib
- 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
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
PomalidomideDrug
Immunomodulatory drug (IMiD) will be administered.
DexamethasoneDrug
Synthetic glucocorticoid with anti-tumor activity will be administered.
BortezomibDrug
Proteasome Inhibitor will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone | Experimental | Not described Receives: Drug: Belantamab mafodotin; Drug: Pomalidomide; Drug: Dexamethasone |
| Arm B: Bortezomib plus Pomalidomide and Dexamethasone | Active comparator | Not described Receives: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter (cm) in short axis.
Measured: Up to approximately 174 weeks
Secondary outcomes (28)
Overall Survival (OS)
Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause.
Measured: Up to approximately 473 weeks
Duration of Response (DoR)
Duration of Response (DoR) defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria.
Measured: Up to approximately 473 weeks
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing at 10^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG.
Measured: Up to approximately 473 weeks
Overall Response Rate (ORR)
ORR will be defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
Measured: Up to approximately 473 weeks
Complete Response Rate (CRR)
Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria.
Measured: Up to approximately 473 weeks
Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better
VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
Measured: Up to approximately 473 weeks
Time to Best Response (TTBR)
TTBR defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG.
Measured: Up to approximately 473 weeks
Time to Response (TTR)
TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG.
Measured: Up to approximately 473 weeks
Time to Progression (TTP)
TTP defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD.
Measured: Up to approximately 473 weeks
Progression-Free Survival 2 (PFS2)
PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier.
Measured: Up to approximately 473 weeks
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately 473 weeks
Number of Participants With Clinically Significant Changes in Hematology Parameters
Blood samples will be collected for the analysis of hematology parameters.
Measured: Up to approximately 473 weeks
Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
Blood samples will be collected for the analysis of clinical chemistry parameters.
Measured: Up to approximately 473 weeks
Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
Measured: Up to approximately 473 weeks
Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
Blood samples will be collected for PK analysis of belantamab mafodotin.
Measured: Up to approximately 473 weeks
Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points
Blood samples will be collected for PK analysis of belantamab mafodotin.
Measured: Up to approximately 473 weeks
Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide
Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Measured: Up to approximately 473 weeks
Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide
Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Measured: Up to approximately 473 weeks
Maximum Concentration (Cmax) for Pomalidomide
Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Measured: Up to approximately 473 weeks
Time of Cmax (Tmax) for Pomalidomide
Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Measured: Up to approximately 473 weeks
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide
Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Measured: Up to approximately 473 weeks
Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide
Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
Measured: Up to approximately 473 weeks
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers.
Measured: Up to approximately 473 weeks
Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further characterized for antibody titers.
Measured: Up to approximately 473 weeks
Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term 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. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
Measured: Up to approximately 473 weeks
Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes 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, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represents better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represents significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value.
Measured: Up to approximately 473 weeks
Change From Baseline in Quality of Life Questionnaire 20-item Multiple Myeloma Module (QLQMY20)
The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning.
Measured: Up to approximately 473 weeks
Change From Baseline in HRQoL as Measured by EORTC IL52
The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning.
Measured: Up to approximately 473 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Oct 2020
- Primary completion29 Jan 2024
- Study completion25 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484623
- Sponsor's protocol ID
- 207499
- Other IDs
- 2018-004354-21, 2018
- Acronym
- DREAMM 8
- Status last verified
- May 2026
- First submitted
- 21 Jul 2020
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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/gsk-patient-level-data-sharing-july2025.pdf
- Expanded access
- Available
Publications
Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Wilkes J, McNamara S, Phillips-Jones A, Morris K, Pompilus F, Purser M, Sule N, Kremer B, Loubert A, Bunod L, M'Hari M, Zhou XL, Fulci G, Mateos MV, Trudel S; DREAMM-8 investigators. Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Nov;12(11):e876-e886. doi: 10.1016/S2352-3026(25)00256-X.
PubMed 41193117Hanafin P, Ho YL, Papathanasiou T, Fulci G, Sule N, Kremer BE, Ferron-Brady G. Belantamab Mafodotin with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: A Comprehensive Exposure-Response Analysis of the DREAMM-8 Study. Target Oncol. 2025 Sep;20(5):833-845. doi: 10.1007/s11523-025-01174-0. Epub 2025 Sep 16.
PubMed 40958065Mateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev V, Pitombeira de Lacerda M, Aparecida-Martinez G, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria V, Dimopoulos MA. Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials. Blood Adv. 2025 Nov 25;9(22):5708-5719. doi: 10.1182/bloodadvances.2025016949.
PubMed 40763276Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Morris K, Pompilus F, Phillips-Jones A, Zhou XL, Fulci G, Sule N, Kremer BE, Opalinska J, Mateos MV, Trudel S; DREAMM-8 Investigators. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2.
PubMed 38828951
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
- ClinicalTrials.gov ID
- NCT04484623
- Acronym / sponsor ID
- DREAMM 8 / 207499
- Conditions
- Multiple Myeloma
- Keywords
- Global Cohort, Belantamab Mafodotin, Relapsed/Refractory Multiple Myeloma, Pomalidomide, Dexamethasone, Bortezomib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 302 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 25 Jun 2029 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone | Experimental | Drug: Belantamab mafodotin, Drug: Pomalidomide, Drug: Dexamethasone |
| Arm B: Bortezomib plus Pomalidomide and Dexamethasone | Active comparator | Drug: Pomalidomide, Drug: Dexamethasone, Drug: Bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Capable of giving signed informed consent.
- Male or female, 18 years or older.
- Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
Key exclusion criteria (28 listed)
- Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
- Prior allogeneic SCT.
- Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
- Plasmapheresis within 7 days prior to the first dose of study drug.
- Received prior treatment with or intolerant to pomalidomide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab mafodotinHumanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered. | Drug | Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone |
| PomalidomideImmunomodulatory drug (IMiD) will be administered. | Drug | Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone, Arm B: Bortezomib plus Pomalidomide and Dexamethasone |
| DexamethasoneSynthetic glucocorticoid with anti-tumor activity will be administered. | Drug | Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone, Arm B: Bortezomib plus Pomalidomide and Dexamethasone |
| BortezomibProteasome Inhibitor will be administered. | Drug | Arm B: Bortezomib plus Pomalidomide and Dexamethasone |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to approximately 174 weeks
PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter (cm) in short axis.
28 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 473 weeks
Duration of Response (DoR)
Time frame: Up to approximately 473 weeks
Minimal Residual Disease (MRD) Negativity Rate
Time frame: Up to approximately 473 weeks
Overall Response Rate (ORR)
Time frame: Up to approximately 473 weeks
Complete Response Rate (CRR)
Time frame: Up to approximately 473 weeks
Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better
Time frame: Up to approximately 473 weeks
Time to Best Response (TTBR)
Time frame: Up to approximately 473 weeks
Time to Response (TTR)
Time frame: Up to approximately 473 weeks
Time to Progression (TTP)
Time frame: Up to approximately 473 weeks
Progression-Free Survival 2 (PFS2)
Time frame: Up to approximately 473 weeks
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 473 weeks
Number of Participants With Clinically Significant Changes in Hematology Parameters
Time frame: Up to approximately 473 weeks
Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
Time frame: Up to approximately 473 weeks
Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
Time frame: Up to approximately 473 weeks
Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
Time frame: Up to approximately 473 weeks
Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points
Time frame: Up to approximately 473 weeks
Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide
Time frame: Up to approximately 473 weeks
Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide
Time frame: Up to approximately 473 weeks
Maximum Concentration (Cmax) for Pomalidomide
Time frame: Up to approximately 473 weeks
Time of Cmax (Tmax) for Pomalidomide
Time frame: Up to approximately 473 weeks
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide
Time frame: Up to approximately 473 weeks
Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide
Time frame: Up to approximately 473 weeks
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Time frame: Up to approximately 473 weeks
Titers of ADAs Against Belantamab Mafodotin
Time frame: Up to approximately 473 weeks
Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to approximately 473 weeks
Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
Time frame: Up to approximately 473 weeks
Change From Baseline in Quality of Life Questionnaire 20-item Multiple Myeloma Module (QLQMY20)
Time frame: Up to approximately 473 weeks
Change From Baseline in HRQoL as Measured by EORTC IL52
Time frame: Up to approximately 473 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41193117Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Wilkes J, McNamara S, Phillips-Jones A, Morris K, Pompilus F, Purser M, Sule N, Kremer B, Loubert A, Bunod L, M'Hari M, Zhou XL, Fulci G, Mateos MV, Trudel S; DREAMM-8 investigators. Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Nov;12(11):e876-e886. doi: 10.1016/S2352-3026(25)00256-X.
- Derived from this study: PubMed 40958065Hanafin P, Ho YL, Papathanasiou T, Fulci G, Sule N, Kremer BE, Ferron-Brady G. Belantamab Mafodotin with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: A Comprehensive Exposure-Response Analysis of the DREAMM-8 Study. Target Oncol. 2025 Sep;20(5):833-845. doi: 10.1007/s11523-025-01174-0. Epub 2025 Sep 16.
- Derived from this study: PubMed 40763276Mateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev V, Pitombeira de Lacerda M, Aparecida-Martinez G, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria V, Dimopoulos MA. Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials. Blood Adv. 2025 Nov 25;9(22):5708-5719. doi: 10.1182/bloodadvances.2025016949.
- Derived from this study: PubMed 38828951Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, Spicka I, Radocha J, Robak P, Kim K, Cavo M, Suzuki K, Morris K, Pompilus F, Phillips-Jones A, Zhou XL, Fulci G, Sule N, Kremer BE, Opalinska J, Mateos MV, Trudel S; DREAMM-8 Investigators. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2.
- Individual participant dataSharing planned: 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/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
122 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Belantamab mafodotin, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline at 122 sites in 18 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 13 inclusion and 28 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in Spain, Japan, China, Australia, Russia and 13 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Mar 2025). 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?
Progression-Free Survival (PFS) (time frame: Up to approximately 174 weeks). 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 NCT04484623, which also lists 4 linked publications.
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 12 Jun 2026.