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NCT04246047: DREAMM 7

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 24 October 2024
What this trial tests

Phase 3 trial testing Belantamab mafodotin in Multiple Myeloma in 494 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
7 May 2020
Primary endpoint
2 October 2023
19 June 2026

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment494
Start date7 May 2020
Primary completion2 October 2023
Estimated completion19 June 2026
Sites144 locations across Italy, Japan, Poland, South Korea, New Zealand, Netherlands, Russia, Belgium

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 41 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)36.628.4 – NA
Daratumumab + Bor + Dex13.411.1 – 17.5

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 41 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: 121/242 (50%)
Deaths: 50/242
Daratumumab + Bor + Dex
Serious: 90/246 (37%)
Deaths: 77/246

Serious adverse events (163 terms)

ReactionSystemBelantamab Mafodotin + Bor…Daratumumab + Bor + Dex
PneumoniaInfections and infestations
PyrexiaGeneral disorders
COVID-19Infections and infestations
COVID-19 pneumoniaInfections and infestations
ThrombocytopeniaBlood and lymphatic system disorders
SepsisInfections and infestations
Lower respiratory tract infectionInfections and infestations
Infusion related reactionInjury, poisoning and procedural complications
AnaemiaBlood and lymphatic system disorders
SyncopeNervous system disorders
Orthostatic hypotensionVascular disorders
BronchitisInfections and infestations
InfluenzaInfections and infestations
DiarrhoeaGastrointestinal disorders
Femur fractureInjury, poisoning and procedural complications
DyspnoeaRespiratory, thoracic and mediastinal disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
Atrial fibrillationCardiac disorders
Acute kidney injuryRenal and urinary disorders
Platelet count decreasedInvestigations
Clostridium difficile colitisInfections and infestations
Staphylococcal sepsisInfections and infestations
Atypical pneumoniaInfections and infestations
Large intestine infectionInfections and infestations
Other adverse events (60 terms — click to expand)

ReactionSystemBelantamab Mafodotin + Bor…Daratumumab + Bor + Dex
ThrombocytopeniaBlood and lymphatic system disorders
Vision blurredEye disorders
Dry eyeEye disorders
PhotophobiaEye disorders
Foreign body sensation in eyesEye disorders
Eye irritationEye disorders
DiarrhoeaGastrointestinal disorders
Eye painEye disorders
AnaemiaBlood and lymphatic system disorders
Peripheral sensory neuropathyNervous system disorders
ConstipationGastrointestinal disorders
Neuropathy peripheralNervous system disorders
COVID-19Infections and infestations
Platelet count decreasedInvestigations
Upper respiratory tract infectionInfections and infestations
CataractEye disorders
FatigueGeneral disorders
Alanine aminotransferase increasedInvestigations
InsomniaPsychiatric disorders
NauseaGastrointestinal disorders
Infusion related reactionInjury, poisoning and procedural complications
Aspartate aminotransferase increasedInvestigations
Gamma-glutamyltransferase increasedInvestigations
Back painMusculoskeletal and connective tissue disorders
PyrexiaGeneral disorders
NeutropeniaBlood and lymphatic system disorders
CoughRespiratory, thoracic and mediastinal disorders
PneumoniaInfections and infestations
HyperglycaemiaMetabolism and nutrition disorders
Blood lactate dehydrogenase increasedInvestigations
HypertensionVascular disorders
HypokalaemiaMetabolism and nutrition disorders
Visual impairmentEye disorders
Oedema peripheralGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
VomitingGastrointestinal disorders
LymphopeniaBlood and lymphatic system disorders
Decreased appetiteMetabolism and nutrition disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Pneumonia, Pyrexia, COVID-19, COVID-19 pneumonia, Thrombocytopenia, Sepsis, Lower respiratory tract infection, Infusion related reaction.

Data from ClinicalTrials.gov NCT04246047 adverse events section.

Sponsor's own description

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibody-Drug Conjugates for Cancer Therapy.
    Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
  2. BCMA-targeted immunotherapy for multiple myeloma.
    Yu B, Jiang T, Liu D. · · 2020 · cited 165× · PMID 32943087 · DOI 10.1186/s13045-020-00962-7
  3. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma.
    Hungria V, Robak P, Hus M, Zherebtsova V, et al · · 2024 · cited 121× · PMID 38828933 · DOI 10.1056/nejmoa2405090
  4. Multiple Myeloma Therapy: Emerging Trends and Challenges.
    Dima D, Jiang D, Singh DJ, Hasipek M, et al · · 2022 · cited 51× · PMID 36077618 · DOI 10.3390/cancers14174082
  5. BCMA-Targeting Therapy: Driving a New Era of Immunotherapy in Multiple Myeloma.
    Cho SF, Lin L, Xing L, Li Y, et al · · 2020 · cited 42× · PMID 32516895 · DOI 10.3390/cancers12061473
  6. Drug resistance in multiple myeloma: Soldiers and weapons in the bone marrow niche.
    Solimando AG, Malerba E, Leone P, Prete M, et al · · 2022 · cited 37× · PMID 36212502 · DOI 10.3389/fonc.2022.973836
  7. Monoclonal Antibodies and Antibody Drug Conjugates in Multiple Myeloma.
    Radocha J, van de Donk NWCJ, Weisel K. · · 2021 · cited 30× · PMID 33805481 · DOI 10.3390/cancers13071571
  8. B-Cell Maturation Antigen (BCMA) as a Target for New Drug Development in Relapsed and/or Refractory Multiple Myeloma.
    Abramson HN. · · 2020 · cited 30× · PMID 32707894 · DOI 10.3390/ijms21155192

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.

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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/NCT04246047.

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