Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM).

Official Title

A Phase 3, Randomized, Multicentre, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

Summary:

This is a multicentre, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Trial Description

Primary Outcome:

• Progression-free Survival (PFS)

Secondary Outcome:

• Overall Survival (OS)
• Minimal Residual Disease (MRD) negativity rate
• Overall Response Rate (ORR)
• Time to response (TTR)
• Duration of Response (DoR)
• Time to Progression (TTP)
• Time to Next Treatment (TTNT)
• Progression-free Survival 2 (PFS2)
• Safety
• European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
• European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
• Recommended iberdomide dose for Stage 2
• Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))
• Maximum plasma concentration (Cmax)
• Time to maximum plasma concentration (Tmax)

This is a multicentre, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B). In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms: Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd) Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd) Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment. The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

View this trial on ClinicalTrials.gov