Expression-linked and R-ISS-adapted stratification for first line therapy in multiple myeloma patients "ELIAS"

EudraCT-No.: 2020-005102-26

Indication: Newly diagnosed multiple myeloma patients eligible for autologous hematopoietic cell transplantation

Study Design: Interventional, prospective, open-label, randomized, multicenter Phase II trial with adaptive design

Therapy: Arm A: Four courses of induction (isatuximab, bortezomib, lenalidomide, Dexamethasone, I-VRD), stem cell mobilization, and aphereses with a subsequent high-dose melphalan and autologous stem cell transfusion. Arm B: Four courses of induction consolidation (I-VRD), stem cell mobilization, and aphereses followed by four courses of consolidation (I-VRD). Both groups will receive subsequently an isatuximab- and lenalidomide-based maintenance therapy.

Primary objective:
Non-inferiority of arm B compared to arm A regarding minimal residual disease (MRD) negativity (at week 36) as determined by flow cytometry and next-generation sequencing

Beteiligte Wissenschaftler:
Dr. rer. medic. Dipl.-Math. R. Koch

Studienleitung:
PD Dr. Cyrus Khandanpour