Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5)

Official Title

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

Summary:

B-cell maturation antigen (BCMA) is a target present on tumour 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 Description

Primary Outcome:

DE Phase: Number of participants achieving dose limiting toxicities (DLT)
DE Phase: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
DE Phase: Number of participants with abnormality in vital signs
DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
CE Phase: Number of participants achieving Overall Response Rate (ORR)

Secondary Outcome:

DE Phase: Number of participants achieving ORR
CE Phase: Number of participants achieving Clinical Benefit Rate (CBR)
DE Phase and CE Phase: Number of participants achieving Partial Response
DE Phase and CE Phase: Number of participants achieving Very Good Partial Response (VGPR)
DE Phase and CE Phase: Number of participants achieving Complete Response (CR)
DE Phase and CE Phase: Number of participants achieving stringent Complete Response (sCR)
DE Phase and CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments
DE Phase and CE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin
DE Phase and CE Phase: feladilimab concentration when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Concentration of anti-drug antibodies (ADAs) against belantamab mafodotin when administered in combination with anti-cancer treatments
DE Phase and CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin
DE Phase and CE Phase: Number of participants with adverse events of special interest (AESI)
DE Phase and CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination
CE Phase: Number of participants achieving Progression-free survival (PFS)
CE Phase: Duration of response (DoR)
CE Phase: Time to response (TTR)
CE Phase: Number of participants achieving Overall survival (OS)
CE Phase: Number of participants with AEs and SAEs
CE Phase: Number of participants with AEs leading to discontinuation
CE Phase: Number of participants with dose reduction or delay
CE Phase: Number of participants with abnormality in vital signs
CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters

View this trial on ClinicalTrials.gov

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