drugset / Trial / NCT04975997

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

NCT04975997

Phase 3 Active not recruiting 939 enrolled Celgene Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2022-06-23
Primary completion
2027-11-16
Completion
2032-06-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Comparator Daratumumab Monoclonal antibody 1800 mg Subcutaneous
Comparator Dexamethasone Small molecule 20 mg Oral
Comparator Dexamethasone Small molecule 40 mg Oral
Subject Iberdomide Small molecule 1 mg Oral
Subject Iberdomide Small molecule 1.3 mg Oral
Subject Iberdomide Small molecule 1.6 mg Oral

Indications