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

This is a multicenter, 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).