- Active, not recruiting
NCT04162210: Phase 3 - Belantamab Mafodotin Vs Pomalidomide + Low-dose Dexamethasone (Pom/Dex) RRMM
Updated: Jan 27
DREAMM 3
Relapsed & Refractory Myeloma v
NCT04162210: Phase 3 - Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in RRMM
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
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 intravenously at 2.5 milligram (mg)/kilogram (kg) on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered orally at a dose of 40 mg 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. Approximately up to 380 participants will be randomized (320 + 60 to fulfill regional country requirements).
Sponsor
ClinicalTrials.gov Identifier: NCT04162210
Official Title: 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 MultipleMyeloma (RRMM) (DREAMM 3)
First Posted : November 14, 2019
Click here to see details on ClinicalTrials.gov
Belantamab Mafodotin
GSK2857916
Belantamab Mafodotin-blmf
Blenrep
J6M0-mcMMAF
Drug: Belantamab mafodotin
Drug: Pom/dex (Pomalidomide plus low dose Dexamethasone)
Locations
United States, Arizona
United States, California
United States, Colorado
United States, Florida
United States, Michigan
United States, Nebraska
United States, Nevada
United States, New York
United States, Ohio
United States, Oregon
United States, Texas
United States, Wisconsin
Canada, Alberta
Europe
United Kingdom
France
Germany
Italy
Netherlands
Spain
Belgium
Bulgaria
Greece
Hungary
Poland
Asia
Japan
Korea, Republic of
Russian Federation
China
China, Jilin
China, Guangdong
Brazil
Australia
Australia, New South Wales
Australia, South Australia
Australia, Tasmania
Australia, Victoria
Australia, Western Australia
22 November 2022
GSK plc (LSE/NYSE: GSK) today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf) following the request of the US Food and Drug Administration (FDA). This request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
Conclusions: Belamaf monotherapy did not demonstrate PFS superiority when compared to a doublet (Pd). However, median PFS was longer for belamaf monotherapy and belamaf induced deeper, more durable responses than Pd. No new safety signals were observed. Subgroup analyses and PRO outcomes will be reported. Belamaf continues to be investigated in combination with established and novel agents.
RELATED POSTS
DREAMM-1
NCT02064387: Phase 1 -Safety Pharm.kinetics Pharm.dynamics Img. & Cl. Activity GSK2857916 - DREAMM-1
DREAMM-2
NCT03525678: Phase 2 - Two Doses of GSK2857916 in Myeloma who have failed Anti-CD38 Ab. DREAMM 2
DREAMM-3
NCT04162210: Phase 3 - Belantamab Mafodotin Vs Pomalidomide + Low-dose Dexamethasone (Pom/Dex) RRMM
DREAMM-4
NCT03848845: Phase 1/2: GSK2857916 in Combination With Pembrolizumab in RRMM Myeloma- DREAMM 4
DREAMM-5
NCT04126200: Phase 1/2 - Belantamab Mafodotin as Monotherapy & With Anti-cancer Rx (RRMM) (DREAMM 5)
DREAMM-6
NCT03544281: Phase 2: GSK2857916 /Len/Dex Vs GSK2857916/Bortezomib/Dex - RRMM Myeloma - DREAMM 6
DREAMM-7
NCT04246047: Phase 3: Belantamab Mafodotin, Bortezomib and Dex RRMM Myeloma (DREAMM 7)
DREAMM-8
NCT04484623: Phase 3 - Belantamab Mafodotin & Pom/Dex (Pd) Vs Bortezomib & Pd in Ref. MM (DREAMM 8)
DREAMM-9
NCT04091126: Phase 1 - Belantamab Mafodotin + Standard of Care New Multiple Myeloma (DREAMM 9) NDMM
DREAMM-12
NCT04398745: Phase 1: Belantamab Mafodotin With Normal and Varying Degree of Impaired Renal Function
DREAMM-13
NCT04398680: Phase 1: Belantamab Mafodotin With Normal & Impaired Hepatic Function (DREAMM 13) RRMM
DREAMM-14
NCT05064358: Phase 2 - Alternative Dosing Regimens of Belantamab Mafodotin RRMM - (DREAMM 14)
NCT038282: Phase 1 - Dose Esc Study Belantamab mafodotin (GSK2857916) in Japanese With Refr MM
NCT03715478: Phase 1/2: Multi-Center Study of GSK2857916 With Pomalidomide & Dex - Algonquin trial
NCT04680468: Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant & Maintenance
NCT04822337: Phase 1/2 - Study of Carfilzomib, Len, Dex & Belantamab Mafodotin in Multiple Myeloma
NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma
NCT04808037: Phase 1/2: Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM (BelaRd)
NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide
AMaRC 19-02 - BelaCarD - Phase I/II - Study of combination belantamab maf, carfilzomib, Dex RRMM
NCT03732703: Phase 1/2: Myeloma-Developing Regimens Using Genomics (MyDRUG)