Last reviewed · How we verify

NCT06956170: DREAMM 8

All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

Active, enrolled Phase 3 Results posted Last updated 11 June 2025
What this trial tests

Phase 3 trial testing Belantamab mafodotin in Multiple Myeloma in 21 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
10 February 2022
Primary endpoint
27 May 2024
30 November 2029

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment21
Start date10 February 2022
Primary completion27 May 2024
Estimated completion30 November 2029
Sites13 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

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) Primary · Up to approximately 120 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-protei

GroupValue95% CI
Belantamab Mafodotin+Pomalidomide+DexamethasoneNA0.2 – NA
Bortezomib + Pomalidomide + Dexamethasone14.81.9 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Belantamab Mafodotin+Pomalidomide+Dexamethasone
Serious: 5/10 (50%)
Deaths: 2/10
Bortezomib + Pomalidomide + Dexamethasone
Serious: 4/11 (36%)
Deaths: 1/11

Serious adverse events (12 terms)

ReactionSystemBelantamab Mafodotin+Pomal…Bortezomib + Pomalidomide …
Sinus node dysfunctionCardiac disorders
CataractEye disorders
OedemaGeneral disorders
CholelithiasisHepatobiliary disorders
Cytomegalovirus chorioretinitisInfections and infestations
InfluenzaInfections and infestations
Morganella infectionInfections and infestations
Pneumocystis jirovecii pneumoniaInfections and infestations
PneumoniaInfections and infestations
Diabetic ketoacidosisMetabolism and nutrition disorders
Colon cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Normal pressure hydrocephalusNervous system disorders
Other adverse events (123 terms — click to expand)

ReactionSystemBelantamab Mafodotin+Pomal…Bortezomib + Pomalidomide …
Vision blurredEye disorders
ConstipationGastrointestinal disorders
Alanine aminotransferase increasedInvestigations
Neutrophil count decreasedInvestigations
ThrombocytopeniaBlood and lymphatic system disorders
Foreign body sensation in eyesEye disorders
DiarrhoeaGastrointestinal disorders
Oedema peripheralGeneral disorders
Aspartate aminotransferase increasedInvestigations
Platelet count decreasedInvestigations
White blood cell count decreasedInvestigations
CataractEye disorders
NauseaGastrointestinal disorders
Injection site reactionGeneral disorders
MalaiseGeneral disorders
HypogammaglobulinaemiaImmune system disorders
Blood alkaline phosphatase increasedInvestigations
Lymphocyte count decreasedInvestigations
Back painMusculoskeletal and connective tissue disorders
DysgeusiaNervous system disorders
RashSkin and subcutaneous tissue disorders
AnaemiaBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
Dry eyeEye disorders
Eye irritationEye disorders
VomitingGastrointestinal disorders
COVID-19Infections and infestations
Herpes zosterInfections and infestations
Upper respiratory tract infectionInfections and infestations
Blood creatinine increasedInvestigations
Gamma-glutamyltransferase increasedInvestigations
Decreased appetiteMetabolism and nutrition disorders
DizzinessNervous system disorders
HypoaesthesiaNervous system disorders
Peripheral sensory neuropathyNervous system disorders
HiccupsRespiratory, thoracic and mediastinal disorders
EosinophiliaBlood and lymphatic system disorders
LeukocytosisBlood and lymphatic system disorders
LymphopeniaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders

Most-reported serious reactions: Sinus node dysfunction, Cataract, Oedema, Cholelithiasis, Cytomegalovirus chorioretinitis, Influenza, Morganella infection, Pneumocystis jirovecii pneumonia.

Data from ClinicalTrials.gov NCT06956170 adverse events section.

Sponsor's own description

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Overcoming resistance to antibody-drug conjugates: mechanisms and emerging strategies.
    Inase A, Kimbara S, Imamura E, Phelps MA, et al · · 2026 · PMID 41630503 · DOI 10.1093/oncolo/oyag020

Verify or expand the search:

Other trials of Belantamab mafodotin

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT06956170.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing