Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Official Title

DREAMM 7: A Multicentre, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma

Summary:

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

Trial Description

Primary Outcome:

• Progression-free survival

Secondary Outcome:

• Complete response rate (CRR)
• Overall response rate (ORR)
• Duration of response (DoR) after administration of study treatment
• Time to response (TTR) after administration of study treatment
• Time to Progression (TTP) after administration of study treatment
• Overall survival (OS)
• Progression-free survival on subsequent line of therapy (PFS2)
• Minimal Residual Disease (MRD) negativity rate after administration of study treatment
• Number of participants with adverse events (AEs)
• Number of participants with serious adverse events (SAEs)
• 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
• 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 Term 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, 20-Item Multiple Myeloma Module (QLQ-MY20)

Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd). Treatment will continue in both arms until progressive disease, death, unacceptable toxicity, withdrawal of consent or end of study, whichever occurs first.

View this trial on ClinicalTrials.gov