Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
NCT ID: NCT04126200
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
208 participants
INTERVENTIONAL
2019-10-07
2027-03-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)
Belantamab mafodotin
Belantamab mafodotin will be administered.
GSK3174998
GSK3174998 will be administered.
Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Feladilimab
feladilimab will be administered.
Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Dostarlimab
Dostarlimab will be administered.
Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Isatuximab
Isatuximab will be administered.
Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Lenalidomide
Lenalidomide will be administered.
Dexamethasone
Dexamethasone will be administered.
Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)
Pomalidomide
Pomalidomide will be administered.
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Dexamethasone
Dexamethasone will be administered.
Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8)
This cohort will enroll Northeast Asian participants.
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Lenalidomide
Lenalidomide will be administered.
Dexamethasone
Dexamethasone will be administered.
Belantamab mafodotin monotherapy cohort expansion
Belantamab mafodotin
Belantamab mafodotin will be administered.
Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)
Belantamab mafodotin
Belantamab mafodotin will be administered.
GSK3174998
GSK3174998 will be administered.
Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Feladilimab
feladilimab will be administered.
Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Dostarlimab
Dostarlimab will be administered.
Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Isatuximab
Isatuximab will be administered.
Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Lenalidomide
Lenalidomide will be administered.
Dexamethasone
Dexamethasone will be administered.
Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)
Pomalidomide
Pomalidomide will be administered.
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Dexamethasone
Dexamethasone will be administered.
Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8)
This cohort will enroll Northeast Asian participants.
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Lenalidomide
Lenalidomide will be administered.
Dexamethasone
Dexamethasone will be administered.
Interventions
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Pomalidomide
Pomalidomide will be administered.
Belantamab mafodotin
Belantamab mafodotin will be administered.
GSK3174998
GSK3174998 will be administered.
Feladilimab
feladilimab will be administered.
Nirogacestat
Nirogacestat will be administered.
Dostarlimab
Dostarlimab will be administered.
Isatuximab
Isatuximab will be administered.
Lenalidomide
Lenalidomide will be administered.
Dexamethasone
Dexamethasone will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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 milligrams (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 deoxyribonucleic acid (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, 7, and 8 respectively.
* Participants with platelets value for Adequate Organ System Function is ≥75 × 10\^9/L.
\- In Japan, participants should reside in Japan and be Japanese as defined by having all biological Japanese grandparents. Similarly, in China, subjects should reside in China and be Chinese as defined by having all biological Chinese grandparents.
Exclusion Criteria
* 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 human immunodeficiency virus (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/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts \>= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.
For participants receiving nirogacestat, HIV drugs that are strong Cytochrome P450 3A4 (CYP3A4) inhibitors are prohibited. HIV drugs that are moderate CYP3A4 inhibitors, while permitted, should be co-administered with caution and must be accompanied by nirogacestat dose modifications.
* Participants with autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years.
* Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.
* Participants with uncontrolled small and/or large intestinal disease.
* Participants with uncontrolled skin disease.
* Participants with any condition causing hypophosphatemia, hypokalemia or hypomagnesemia which is refractory to electrolyte replacement.
* Participants with previous administration of a gamma secretase inhibitor.
* Participants with concomitant administration of a strong CYP3A4 inhibitor or inducer.
* Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
* Participants who have received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent.
* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.
* Participants with Severe hypersensitivity to Isatuximab-irfc or to any of its excipients.
* Participants with prior treatment with other anti-CD38 monoclonal antibody within 6 months of the first dose of study drug treatment.
* Participants with known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80.
* Participants with active or history of venous thromboembolism within the past 3 months.
* Participants with evidence of active mucosal or internal bleeding.
* Participants with contraindications to or are unwilling to undergo protocol-required anti-thrombotic prophylaxis or unable to tolerate antithrombolitic prophalaxis.
\- Participants who discontinued prior treatment with lenalidomide due to intolerable adverse events.
\- Participants who discontinued prior treatment with pomalidomide due to intolerable adverse events.
* Pregnant or lactating female or female who are interrupting lactation.
* Previously diagnosed with interstitial lung disease or current complication of interstitial lung disease.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Grand Rapids, Michigan, United States
GSK Investigational Site
Madison, Wisconsin, United States
GSK Investigational Site
Fitzroy, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Porto Alegre, , Brazil
GSK Investigational Site
Salvador, , Brazil
GSK Investigational Site
São Paulo, , Brazil
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Lille, , France
GSK Investigational Site
Villejuif, , France
GSK Investigational Site
Frankfurt, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Kiel, , Germany
GSK Investigational Site
Leipzig, , Germany
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Leeuwarden, , Netherlands
GSK Investigational Site
Utrecht, , Netherlands
GSK Investigational Site
Oslo, , Norway
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Incheon, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Ulsan, , South Korea
GSK Investigational Site
Badalona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
PamplonaNavarra, , Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, , Spain
GSK Investigational Site
Falun, , Sweden
GSK Investigational Site
Stockholm, , Sweden
Countries
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References
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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.
Nooka 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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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208887
Identifier Type: -
Identifier Source: org_study_id