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Clinical trial of idecabtagene vicleucel with lenalidomide versus treatment with LEN alone in adult participants with newly diagnosed multiple myeloma.
THE GOAL OF THIS STUDY IS TO LEARN MORE ABOUT THE DRUG CALLED IDE-CEL. THE STUDY IS TO LEARN WHETHER IDE-CEL, WHEN GIVEN WITH A STANDARD MYELOMA MAINTENANCE TREATMENT CALLED LENALIDOMIDE (LEN), WILL BE SAFE AND MORE EFFECTIVE, COMPARED TO LEN GIVEN ALONE (IN MONOTHERAPY). IDE-CEL IS A NEW DRUG DEVELOPED BY THE SPONSOR OF THIS CLINICAL TRIAL. IDE-CEL HAS BEEN APPROVED IN SOME COUNTRIES FOR THE TREATMENT OF RELAPSED AND REFRACTORY MULTIPLE MYELOMA (MM). HOWEVER, ITS USE IN THIS STUDY IS STILL EXPERIMENTAL AND THE INVESTIGATING PHYSICIANS ARE TRYING TO LEARN MORE ABOUT IT.
Technical Summary
- STUDY TO COMPARE THE EFFICACY AND SAFETY OF IDECABTAGENE VICLEUCEL (IDE-CEL) WITH LENALIDOMIDE (LEN) MAINTENANCE THERAPY VERSUS LEN MAINTENANCE THERAPY ALONE IN ADULT PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (MMND) WHO HAVE SUBOPTIMAL RESPONSE AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT).
- Code EudraCT: 2022-501346-30-00
- Protocol number: CA089-1043
- Promoter: Celgene Corporation
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