Loading clinical trials...

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

NCT04162210•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Capable of giving signed informed consent.
•Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
•Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT), or is considered transplant ineligible; Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a proteasome inhibitor (given separately or in combination), and must have documented disease progression on, or within 60 days of, completion of the last treatment or must be non-responsive while on last treatment, where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 complete treatment cycles. In such cases lack of achieving of at least MR must be determined no earlier than at least 4 weeks after the last treatment.
•Has measurable disease with at least one of the following: Serum M-protein \>=0.5 gram per deciliter (g/dL) (\>=5 gram per Liter); Urine M-protein \>=200 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level \>=10 milligram per deciliter (mg/dL) (\>=100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65).
•Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: Transplant was \>100 days prior to initiating study treatment; No active infection(s).
•Adequate organ system functions as defined: Absolute neutrophil count (ANC) \>=1.0\*10\^9/L; Hemoglobin \>= 8.0 g/dL; Platelets \>= 50x10\^9/L; Total bilirubin \<=1.5\* Upper limit of normal (ULN) (isolated bilirubin \>1.5\*ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent); ALT \<=2.5\*ULN; Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2); Spot urine (albumin/creatinine ratios) \<=500 milligram per gram (mg/g) (56 milligram per millimoles \[mg/mmol\]).
•Contraceptive use by men or women 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 during the intervention period and until 6 months after the last dose of study intervention to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below depending on whether they are randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have undergone a successful vasectomy: Agree to use a male condom throughout study treatment including the 6 month follow-up period even if they have undergone a successful vasectomy and a female partner to use an additional highly effective contraceptive method with a failure rate of \<1 percent per year when having sexual intercourse with a pregnant woman or a woman of childbearing potential who is not currently pregnant. Four weeks for male participants on Treatment Arm 2 (pom/dex).
•All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], version 5.0, 2017) must be \<=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.
•Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
+13 more criteria

Exclusion Criteria

•Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes); active plasma cell leukemia at the time of screening.
•Systemic anti-myeloma therapy or use of an investigational drug within \<14 days or 5 half-lives, whichever is shorter, before the first dose of study intervention.
•Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving the first dose of study intervention.
•Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide treatment.
•Plasmapheresis within 7 days prior to the first dose of study intervention.
•Prior allogeneic stem cell transplant. (Participants who have undergone syngeneic transplant will be allowed only if no history of, or currently active, Graft-Versus-Host Disease \[GvHD\]).
•Any major surgery within the last 4 weeks.

Locations (102)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Pueblo, Colorado, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Clifton Park, New York, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Corvallis, Oregon, United States

GSK Investigational Site

Eugene, Oregon, United States

GSK Investigational Site

Tyler, Texas, United States

GSK Investigational Site

Milwaukee, Wisconsin, United States

Key Dates

Start Date

March 24, 2021

Primary Completion Date

September 12, 2022

Completion Date

March 11, 2027

Last Updated

February 11, 2026

Enrollment

325

ACTUAL participants

Conditions

Multiple Myeloma

Interventions

Belantamab mafodotin

DRUG

Pom/dex (Pomalidomide plus low dose Dexamethasone)

DRUG

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

View study

RECRUITINGPHASE2

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

NCT06179888

Multiple Myeloma

View study

RECRUITINGPHASE1/PHASE2

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Inclusion Criteria

Exclusion Criteria

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Elranatamab in R/R Multiple Myeloma