Excaliber-RRMM
Research type
Research Study
Full title
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) (EXCALIBER-RRMM)
IRAS ID
1003756
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2020-000431-49
Research summary
Despite advances in the early treatment of relapsed or refractory multiple myeloma (RRMM), including with monoclonal antibodies (eg daratumumab), patients continue to suffer from frequent relapses and treatment-resistant disease.
Iberdomide shares a similar mechanism of action with lenalidomide and pomalidomide, which have played a critical role in significantly improving outcomes for patients with MM. The increased potency and efficiency of iberdomide results in stronger anti-myeloma activities, enhanced immune modulation and increased depth of response in preclinical models of combined standard of care agents compared to lenalidomide or pomalidomide.
The purpose of this study is to investigate whether iberdomide works to treat RRMM when combined with daratumumab and dexamethasone (Group A). In this study, the safety and effectiveness of the iberdomide combination will be compared to a combination already approved for the treatment of multiple myeloma - daratumumab, bortezomib and dexamethasone (Group B). Participants will be randomly assigned to Group A or B.
Treatment A is given in 28-day cycles, with hospital visits required 4 times in Cycles 1 and 2, twice in Cycles 3-6 and once in subsequent cycles. Treatment B is given initially in 21-day cycles with hospital visits required 3 times in Cycles 1-3, twice in Cycles 4-8 and once in subsequent 28-day cycles. The study will last for around 7 years. Study treatment will continue as long as participant disease does not worsen and as long as tolerated. Participants will also be contacted every 4 months for at least 5 years from the date the last participant enrolled in the study.
Assessments will include physical examination, ECG and scans (CT/PET-CT/MRI/x-ray), blood, urine and bone marrow sampling and health-related quality of life questionnaires.
This study is sponsored by the pharmaceutical company Celgene Corporation, USA. Approximately 736 participants worldwide will take part.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0243
Date of REC Opinion
24 Sep 2021
REC opinion
Further Information Favourable Opinion