A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects 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).
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:
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).
Inclusion Criteria
Exclusion Criteria
Ciudad Autanoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
Ottawa, Quebec K1H 8L6, Canada
Chaoyang District, 100020, China
Hangzhou, Zhejiang, 310006, China
Ostrava-Poruba, 708 52, Czechia
Hyderabad, Andhra Pradesh 500084, India
San Giovanni Rotondo FG, 71013, Italy
Higashi-Ibaraki-gun, Ibaraki 311-3193, Japan
Shimotsuga, Tochigi 321-0293, Japan
Nerima-ku, Tokyo 179-0072, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Chuo-shi, Yamanashi 4093898, Japan
Shibuya-ku, 150-8935, Japan
Hwasun-gun, 519-809, South Korea
Niao-Sung Hsiang Kaohsiung County, 83301, Taiwan
Belfast Northern Ireland, BT9 7AD, United Kingdom
Canterbury Kent, CT1 3NG, United Kingdom
Lancashire Blackpool, FY3 8NR, United Kingdom