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); also referred to as GSK'916; 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 GSK'916 (belantamab mafodotin) in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma (RRMM). The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously. This study will include two parts; dose exploration (DE) and cohort expansion (CE). In the DE phase, the safety and tolerability profile of GSK'916 (belantamab mafodotin) will be evaluated when administered in combination with other anti-cancer agents. This may identify a recommended phase 2 dose (RP2D) for each partner, as well as efficacy of each combination. The CE phase of the study will evaluate the clinical activity of the combinations in comparison to monotherapy in additional participants with RRMM.

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 abnormality in hematology parameters
  • DE Phase: Number of participants with abnormality in clinical chemistry parameters
  • DE Phase: Number of participants with abnormality in routine urinalysis 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: Number of participants achieving Partial Response (PR)
  • DE Phase: Number of participants achieving Very Good Partial Response (VGPR)
  • DE Phase: Number of participants achieving Complete Response (CR)
  • DE Phase: Number of participants achieving stringent Complete Response (sCR)
  • DE Phase: GSK'916 (belantamab mafodotin) concentration when administered in combination with GSK3174998
  • DE Phase: GSK'916 (belantamab mafodotin) concentration when administered in combination with GSK3359609
  • DE Phase: GSK'916 (belantamab mafodotin) concentration when administered in combination with nirogacestat
  • DE Phase: GSK3174998 concentration when administered in combination with GSK'916 (belantamab mafodotin)
  • DE Phase: GSK3359609 concentration when administered in combination with GSK'916 (belantamab mafodotin)
  • DE Phase: Nirogacestat concentration when administered in combination with GSK'916 (belantamab mafodotin)
  • DE Phase: Concentration of anti-drug antibodies (ADAs) against GSK'916 (belantamab mafodotin) when administered in combination with GSK3174998
  • DE Phase: Concentration of ADAs against GSK'916 (belantamab mafodotin) when administered in combination with GSK3359609
  • DE Phase: Concentration of ADAs against GSK'916 (belantamab mafodotin) when administered in combination with nirogacestat
  • DE Phase: Concentration of ADAs against GSK3174998 when administered in combination with GSK'916 (belantamab mafodotin)
  • DE Phase: Concentration of ADAs against GSK3359609 when administered in combination with GSK'916 (belantamab mafodotin)
  • DE Phase: Number of participants with adverse events of special interest (AESI) for GSK'916 (belantamab mafodotin) when given in combination with GSK3174998
  • DE Phase: Number of participants with AESI for GSK'916 (belantamab mafodotin) when given in combination with GSK3359609
  • DE Phase: Number of participants with AESI for GSK'916 (belantamab mafodotin) when given in combination with nirogacestat
  • DE Phase: Number of participants with AESI for GSK3174998 when administered in combination with GSK'916 (belantamab mafodotin)
  • DE Phase: Number of participants with AESI for GSK3359609 when administered in combination with GSK'916 (belantamab mafodotin)
  • DE Phase: Number of participants with AESI for nirogacestat when administered in combination with GSK'916 (belantamab mafodotin)
  • DE 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) after administration of GSK'916 (belantamab mafodotin) in combination with GSK3174998
  • CE Phase: DoR after administration of GSK'916 (belantamab mafodotin) in combination with GSK3359609
  • CE Phase: DoR after administration of GSK'916 (belantamab mafodotin) in combination with nirogacestat
  • CE Phase: Time to response (TTR) after administration of GSK'916 (belantamab mafodotin) in combination with GSK3174998
  • CE Phase: TTR after administration of GSK'916 (belantamab mafodotin) in combination with GSK3359609
  • CE Phase: TTR after administration of GSK'916 (belantamab mafodotin) in combination with nirogacestat
  • CE Phase: Number of participants achieving PR
  • CE Phase: Number of participants achieving VGPR
  • CE Phase: Number of participants achieving CR
  • CE Phase: Number of participants achieving sCR
  • 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 abnormality in hematology parameters
  • CE Phase: Number of participants with abnormality in clinical chemistry parameters
  • CE Phase: Number of participants with abnormality in routine urinalysis parameters
  • CE Phase: Number of participants with abnormality in electrocardiogram (ECG) parameters
  • CE Phase: Number of participants with AESI for GSK'916 (belantamab mafodotin) when given in combination with GSK3174998
  • CE Phase: Number of participants with AESI for GSK'916 (belantamab mafodotin) when given in combination with GSK3359609
  • CE Phase: Number of participants with AESI for GSK'916 (belantamab mafodotin) when given in combination with nirogacestat
  • CE Phase: Number of participants with AESI for GSK3174998 when administered in combination with GSK'916 (belantamab mafodotin)
  • CE Phase: Number of participants with AESI for GSK3359609 when administered in combination with GSK'916 (belantamab mafodotin)
  • CE Phase: Number of participants with AESI for nirogacestat when administered in combination with GSK'916 (belantamab mafodotin)
  • CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination
  • CE Phase: Concentration observed of GSK'916 (belantamab mafodotin) when administered in combination with GSK3174998
  • CE Phase: Concentration observed of GSK'916 (belantamab mafodotin) when administered in combination with GSK3359609
  • CE Phase: Concentration observed of GSK'916 (belantamab mafodotin) when administered in combination with nirogacestat
  • CE Phase: Concentration observed of GSK3174998 when administered in combination with GSK'916 (belantamab mafodotin)
  • CE Phase: Concentration observed of GSK3359609 when administered in combination with GSK'916 (belantamab mafodotin)
  • CE Phase: Concentration observed of nirogacestat when administered in combination with GSK'916 (belantamab mafodotin)
  • CE Phase: Concentration of ADAs against GSK'916 (belantamab mafodotin) when administered in combination with GSK3174998
  • CE Phase: Concentration of ADAs against GSK'916 (belantamab mafodotin) when administered in combination with GSK3359609
  • CE Phase: Concentration of ADAs against GSK'916 (belantamab mafodotin) when administered in combination with nirogacestat
  • CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with GSK'916 (belantamab mafodotin)
  • CE Phase: Concentration of ADAs against GSK3359609 when administered in combination with GSK'916 (belantamab mafodotin)

View this trial on ClinicalTrials.gov

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