Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Active, enrolledPhase 3Results postedLast updated 31 March 2026
What this trial tests
Phase 3 trial testing Belantamab mafodotin in Multiple Myeloma in 325 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG)Primary· Up to 27 months
PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter \[g/dL\]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum an
Group
Value
95% CI
Belantamab Mafodotin
11.2
6.4 – 14.5
Pomalidomide Plus Dexamethasone
7.0
4.6 – 10.6
Adverse events — posted to ClinicalTrials.gov
Time frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 27 months. Data collection is still ongoing and additional results will be provided after study completion..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Belantamab Mafodotin
Serious: 94/217 (43%)
Deaths: 83/217
Pomalidomide Plus Dexamethasone
Serious: 40/102 (39%)
Deaths: 38/102
Serious adverse events (108 terms)
Reaction
System
Belantamab Mafodotin
Pomalidomide Plus Dexameth…
Pneumonia
Infections and infestations
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Thrombocytopenia
Blood and lymphatic system disorders
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Pyrexia
General disorders
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COVID-19
Infections and infestations
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COVID-19 pneumonia
Infections and infestations
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Anaemia
Blood and lymphatic system disorders
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Febrile neutropenia
Blood and lymphatic system disorders
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Infusion related reaction
Injury, poisoning and procedural complications
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Platelet count decreased
Investigations
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Septic shock
Infections and infestations
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Urinary tract infection
Infections and infestations
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Sepsis
Infections and infestations
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Fall
Injury, poisoning and procedural complications
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Pathological fracture
Musculoskeletal and connective tissue disorders
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Spinal cord compression
Nervous system disorders
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Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07224672 — A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, an
· Phase 2
· not yet recruiting
NCT07227311 — A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants
· Phase 2
· not yet recruiting
NCT06679101 — A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab
· Phase 3
· recruiting
NCT05922501 — Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT05714839 — A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monother
· Phase 1, PHASE2
· recruiting
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
· Phase 3
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 31 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04162210.