Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

Official Title

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

Summary:

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

Trial Description

Primary Outcome:

• Progression-free survival (PFS)

• Minimal residual disease (MRD) negativity rate
• Overall response rate (ORR)
• Complete response rate (CRR)
• Very good partial response (VGPR) or better rate
• Duration of response (DoR)
• Time to best response (TTBR)
• Time to response (TTR)
• Time to progression (TTP)
• Overall survival (OS)
• Progression-free survival on subsequent line of therapy (PFS2)
• Number of participants with adverse events (AEs) and serious adverse events (SAEs)
• Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
• Number of participants with abnormal ocular findings on ophthalmic examination
• Plasma concentrations of belantamab mafodotin at indicated time points
• Plasma concentrations of total monoclonal antibody (mAb) at indicated time points
• Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
• Maximum observed concentration (Cmax) for pomalidomide
• Time of Cmax (Tmax) for pomalidomide
• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-t]) for pomalidomide
• Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
• Titers of ADAs against belantamab mafodotin
• Change from Baseline in symptoms as measured by patient-reported outcome version of the common terminology criteria for adverse events (PRO-CTCAE)
• Change from Baseline in impacts as measured by PRO-CTCAE
• Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30)
• Change from Baseline in HRQoL as measured by EORTC item library 52 (IL52)
• Change from Baseline in HRQoL as measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20)

View this trial on ClinicalTrials.gov