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NCT06868654: DREAMM 7

China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Active, enrolled Phase 3 Results posted Last updated 23 April 2025
What this trial tests

Phase 3 trial testing Belantamab mafodotin in Multiple Myeloma in 72 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
28 July 2021
Primary endpoint
3 April 2024
19 June 2026

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment72
Start date28 July 2021
Primary completion3 April 2024
Estimated completion19 June 2026
Sites11 locations across China

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 32 months

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= 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, dif

GroupValue95% CI
Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)NA20.2 – NA
Daratumumab + Bor + Dex8.44.9 – 21.5

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 32 months. 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 + Bortezomib (Bor) + Dexamethasone (Dex)
Serious: 25/30 (83%)
Deaths: 4/30
Daratumumab + Bor + Dex
Serious: 27/40 (68%)
Deaths: 14/40

Serious adverse events (49 terms)

ReactionSystemBelantamab Mafodotin + Bor…Daratumumab + Bor + Dex
PneumoniaInfections and infestations
ThrombocytopeniaBlood and lymphatic system disorders
Platelet count decreasedInvestigations
CataractEye disorders
Herpes zosterInfections and infestations
COVID-19Infections and infestations
IleusGastrointestinal disorders
Chronic kidney diseaseRenal and urinary disorders
GastroenteritisInfections and infestations
Abdominal infectionInfections and infestations
BronchitisInfections and infestations
Febrile infectionInfections and infestations
Urinary tract infectionInfections and infestations
PancytopeniaBlood and lymphatic system disorders
Neutrophil count decreasedInvestigations
Gastrointestinal haemorrhageGastrointestinal disorders
ColitisGastrointestinal disorders
Gastritis erosiveGastrointestinal disorders
Inguinal herniaGastrointestinal disorders
Intestinal obstructionGastrointestinal disorders
Large intestine polypGastrointestinal disorders
Reflux gastritisGastrointestinal disorders
Retinal detachmentEye disorders
UveitisEye disorders
Vision blurredEye disorders
Other adverse events (120 terms — click to expand)

ReactionSystemBelantamab Mafodotin + Bor…Daratumumab + Bor + Dex
AnaemiaBlood and lymphatic system disorders
Platelet count decreasedInvestigations
White blood cell count decreasedInvestigations
HypokalaemiaMetabolism and nutrition disorders
Lymphocyte count decreasedInvestigations
PneumoniaInfections and infestations
Aspartate aminotransferase increasedInvestigations
Neutrophil count decreasedInvestigations
Alanine aminotransferase increasedInvestigations
HypertriglyceridaemiaMetabolism and nutrition disorders
Infusion related reactionInjury, poisoning and procedural complications
HypocalcaemiaMetabolism and nutrition disorders
Upper respiratory tract infectionInfections and infestations
ThrombocytopeniaBlood and lymphatic system disorders
COVID-19Infections and infestations
Vision blurredEye disorders
HypoalbuminaemiaMetabolism and nutrition disorders
DiarrhoeaGastrointestinal disorders
HyperglycaemiaMetabolism and nutrition disorders
HypophosphataemiaMetabolism and nutrition disorders
Gamma-glutamyltransferase increasedInvestigations
Blood lactate dehydrogenase increasedInvestigations
Foreign body sensation in eyesEye disorders
HypercholesterolaemiaMetabolism and nutrition disorders
HypermagnesaemiaMetabolism and nutrition disorders
ConstipationGastrointestinal disorders
Neuropathy peripheralNervous system disorders
InsomniaPsychiatric disorders
HyperuricaemiaMetabolism and nutrition disorders
HyponatraemiaMetabolism and nutrition disorders
Herpes zosterInfections and infestations
MalaiseGeneral disorders
CataractEye disorders
PhotophobiaEye disorders
Weight decreasedInvestigations
PyrexiaGeneral disorders
Dry eyeEye disorders
Blood bilirubin increasedInvestigations
Blood creatinine increasedInvestigations
Blood alkaline phosphatase increasedInvestigations

Most-reported serious reactions: Pneumonia, Thrombocytopenia, Platelet count decreased, Cataract, Herpes zoster, COVID-19, Ileus, Chronic kidney disease.

Data from ClinicalTrials.gov NCT06868654 adverse events section.

Sponsor's own description

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.

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/NCT06868654.

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