TriangleNCT04484623 · CITED IN SOURCE DOCUMENTS
Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-06-12
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).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-Free Survival (PFS)
Overall Survival (OS)
Duration of Response (DoR)
Minimal Residual Disease (MRD) Negativity Rate
Overall Response Rate (ORR)
Complete Response Rate (CRR)
Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better
Time to Best Response (TTBR)
Time to Response (TTR)
Time to Progression (TTP)
Progression-Free Survival 2 (PFS2)
Number of Participants With Adverse Events (AEs)
Number of Participants With Clinically Significant Changes in Hematology Parameters
Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points
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
Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide
Maximum Concentration (Cmax) for Pomalidomide
Time of Cmax (Tmax) for Pomalidomide
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide
Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Titers of ADAs Against Belantamab Mafodotin
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)
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)
Change From Baseline in Quality of Life Questionnaire 20-item Multiple Myeloma Module (QLQMY20)
Change From Baseline in HRQoL as Measured by EORTC IL52
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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; 1. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or 2. Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter \[L\]), or 3. 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. Exclusion Criteria: * 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. * 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; 1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block. 2. Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting . 3. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system 4. Uncontrolled hypertension. * Any major surgery within the last 4 weeks. * Previous or concurrent invasive malignancy other than multiple myeloma, except: 1. The disease must be considered medically stable for at least 2 years; or 2. 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Belantamab mafodotin
- Drug: Pomalidomide
- Drug: Dexamethasone
- label
- Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
- type
- EXPERIMENTAL
- intervention Names
- Drug: Pomalidomide
- Drug: Dexamethasone
- Drug: Bortezomib
- label
- Arm B: Bortezomib plus Pomalidomide and Dexamethasone
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
- description
- Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
- name
- Belantamab mafodotin
- type
- DRUG
- arm Group Labels
- Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
- Arm B: Bortezomib plus Pomalidomide and Dexamethasone
- description
- Immunomodulatory drug (IMiD) will be administered.
- name
- Pomalidomide
- type
- DRUG
- arm Group Labels
- Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
- Arm B: Bortezomib plus Pomalidomide and Dexamethasone
- description
- Synthetic glucocorticoid with anti-tumor activity will be administered.
- name
- Dexamethasone
- type
- DRUG
- arm Group Labels
- Arm B: Bortezomib plus Pomalidomide and Dexamethasone
- description
- Proteasome Inhibitor will be administered.
- name
- Bortezomib
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 302
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Progression-Free Survival (PFS)
- time Frame
- Up to approximately 174 weeks
- secondary Outcomes
- description
- Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause.
- measure
- Overall Survival (OS)
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Duration of Response (DoR)
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Minimal Residual Disease (MRD) Negativity Rate
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Overall Response Rate (ORR)
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Complete Response Rate (CRR)
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Time to Best Response (TTBR)
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Time to Response (TTR)
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Time to Progression (TTP)
- time Frame
- Up to approximately 473 weeks
- description
- 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.
- measure
- Progression-Free Survival 2 (PFS2)
- time Frame
- Up to approximately 473 weeks
- measure
- Number of Participants With Adverse Events (AEs)
- time Frame
- Up to approximately 473 weeks
- description
- Blood samples will be collected for the analysis of hematology parameters.
- measure
- Number of Participants With Clinically Significant Changes in Hematology Parameters
- time Frame
- Up to approximately 473 weeks
Full study description
- brief 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).
Source references
- references
- citation
- 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.
- pmid
- 41193117
- type
- DERIVED
- citation
- Hanafin 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.
- pmid
- 40958065
- type
- DERIVED
- citation
- Mateos 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.
- pmid
- 40763276
- type
- DERIVED
- citation
- Dimopoulos 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.
- pmid
- 38828951
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- modification, and 98% of patients regained normal vision from 20/50 or worse.</li></ul></div></li><li>A prospective randomized trial (<a href="/clinicaltrials/NCT04484623">NCT04484623</a>) included 302 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Pd (BPd) or PVd (pomalidomide,
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- , and 98% of patients regained normal vision from 20/50 or worse.</li></ul></div></li><li>A prospective randomized trial (<a href="/clinicaltrials/NCT04484623">NCT04484623</a>) included 302 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Pd (BPd) or PVd (pomalidomide, bortezomib, a
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- Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version
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- Updated: April 25, 2025
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- 2025-04-25T12:00:00Z
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- April 25, 2025
Preserved source evidence · Not medical advice