Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
DREAMM 5
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5
2 other identifiers
interventional
208
13 countries
38
Brief Summary
B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Oct 2019
Longer than P75 for phase_1 multiple-myeloma
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2019
CompletedFirst Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2025
CompletedResults Posted
Study results publicly available
May 6, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2027
ExpectedMay 6, 2026
April 1, 2026
5.5 years
October 11, 2019
April 15, 2026
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Randomized Across Sub-studies
Number of Participants who passed screening and were randomized across sub studies are presented.
Day 1
Study Arms (15)
Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)
EXPERIMENTALBelantamab mafodotin+feladilimab dose exploration (Sub-study 2)
EXPERIMENTALBelantamab mafodotin+nirogacestat dose exploration(Sub-study 3)
EXPERIMENTALBelantamab mafodotin+dostarlimab dose exploration(Sub-study 4)
EXPERIMENTALBelantamab mafodotin+isatuximab dose exploration (Sub-study 5)
EXPERIMENTALBelantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)
EXPERIMENTALBelantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)
EXPERIMENTALBelantamab mafodotin monotherapy cohort expansion
ACTIVE COMPARATORBelantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)
EXPERIMENTALBelantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)
EXPERIMENTALBelantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)
EXPERIMENTALBelantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)
EXPERIMENTALBelantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)
EXPERIMENTALBelantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)
EXPERIMENTALBelantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)
EXPERIMENTALInterventions
Lenalidomide will be administered.
Pomalidomide will be administered.
Isatuximab will be administered.
Dexamethasone will be administered.
Belantamab mafodotin will be administered.
GSK3174998 will be administered.
feladilimab will be administered.
Nirogacestat will be administered.
Dostarlimab will be administered.
Eligibility Criteria
You may qualify if:
- Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
- Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
- Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
- Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was \>100 days prior to study enrolment and with no active infection(s).
- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (\<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
- Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (\>=)0.5 gram per deciliter (\>=5 gram per liter) or Urine M-protein \>=200 mg per 24 hours or Serum free light chain (FLC) assay: Involved FLC level \>=10 mg per deciliter (\>=100 mg per Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65).
- Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV DNA undetectable during screening.
- Participants who are currently receiving physiological doses oral steroids (\<10 mg/day), inhaled steroids or ophthalmalogical steroids.
- Participants with contraception requirements specific to Sub-study 6 and 7 respectively.
- Participants with platelets value for Adequate Organ System Function is ≥75 × 10\^9/L.
You may not qualify if:
- Participants with current corneal epithelial disease except mild punctate keratopathy.
- Participants with evidence of cardiovascular risk
- Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
- Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
- Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within \<14 days.
- Participants with prior radiotherapy within 2 weeks of start of study therapy.
- Participants with prior allogeneic transplant are prohibited.
- Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
- Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
- Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
- Participants with \>=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
- Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug.
- Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment.
- Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM.
- Participants with Known HIV infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load\<400 copies/mL b) CD4+ T-cell (CD4+) counts \>= 350 cells/microliter (µL) c) No history of AIDS-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (38)
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Grand Rapids, Michigan, 49546, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Porto Alegre, 90110-270, Brazil
GSK Investigational Site
Salvador, 41253-190, Brazil
GSK Investigational Site
São Paulo, 04537-080, Brazil
GSK Investigational Site
Vancouver, British Columbia, V5Z1M9, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
GSK Investigational Site
Toronto, Ontario, M5G 2M9, Canada
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Villejuif, 94805, France
GSK Investigational Site
Frankfurt, 60590, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Kiel, 24105, Germany
GSK Investigational Site
Leipzig, 04103, Germany
GSK Investigational Site
Athens, 11528, Greece
GSK Investigational Site
Mexico City, 01330, Mexico
GSK Investigational Site
Leeuwarden, 8934 AD, Netherlands
GSK Investigational Site
Utrecht, 3584 CX, Netherlands
GSK Investigational Site
Oslo, 0450, Norway
GSK Investigational Site
Gdansk, 80-214, Poland
GSK Investigational Site
Katowice, 40-519, Poland
GSK Investigational Site
Lodz, 93-513, Poland
GSK Investigational Site
Lublin, 20-081, Poland
GSK Investigational Site
Incheon, 21565, South Korea
GSK Investigational Site
Seoul, 03080, South Korea
GSK Investigational Site
Seoul, 06351, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Madrid, 28027, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
PamplonaNavarra, 31008, Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223, Spain
GSK Investigational Site
Falun, SE-791 82, Sweden
GSK Investigational Site
Stockholm, SE-141 86, Sweden
Related Publications (2)
Hosoya H, Sidana S. Antibody-Based Treatment Approaches in Multiple Myeloma. Curr Hematol Malig Rep. 2021 Apr;16(2):183-191. doi: 10.1007/s11899-021-00624-6. Epub 2021 Mar 17.
PMID: 33730360DERIVEDNooka AK, Weisel K, van de Donk NW, Routledge D, Otero PR, Song K, Quach H, Callander N, Minnema MC, Trudel S, Jackson NA, Ahlers CM, Im E, Cheng S, Smith L, Hareth N, Ferron-Brady G, Brouch M, Montes de Oca R, Paul S, Holkova B, Gupta I, Kremer BE, Richardson P. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Future Oncol. 2021 Jun;17(16):1987-2003. doi: 10.2217/fon-2020-1269. Epub 2021 Mar 8.
PMID: 33682447DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 15, 2019
Study Start
October 7, 2019
Primary Completion
April 17, 2025
Study Completion (Estimated)
March 11, 2027
Last Updated
May 6, 2026
Results First Posted
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.