EXCALIBER-Maintenance
Research type
Research Study
Full title
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
IRAS ID
1007876
Contact name
GSM-CT GSM-CT
Contact email
Sponsor organisation
Celgene Corporation
Research summary
This study is being sponsored by Celgene, a global biopharmaceutical company. The purpose of this study is to see how well a new drug called iberdomide works to treat multiple myeloma and how safe it is, when compared with lenalidomide in patients who received and recovered from an autologous stem cell transplant. Multiple myeloma is a type of bone marrow cancer. The treatment being studied, iberdomide, is investigational, which means it is not approved by Health Authorities in the UK for multiple myeloma. The other treatment being studied, lenalidomide, is a drug that is approved in many countries for the treatment of multiple myeloma, and it is used as maintenance treatment after the completion of autologous stem cell transplant. All study treatments will be taken by mouth. The study has 2 stages. Based on when the patient agrees to participate in the study, he/she may be selected to participate in either stage, but not both stages. Approximately 1216 patients are expected to take part in this study, with approximately 120 during Stage 1 and approximately 1096 during Stage 2. The study is divided into 3 separate periods: screening, treatment and follow-up. The patient will be put by chance into one of the groups to receive either the experimental treatment or the standard treatment. The patient will continue taking his/her study treatment during this treatment phase for as long as it works for him/her unless the study ends sooner. The total study treatment period may take up to 4 years but may vary depending on how the patient responds to the study treatment. The patient will also have regular visits to the hospital for some tests. After the patient discontinues the study treatment he/she will enter the follow-up phase.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0404
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion