Phase III clinical trial - Hématologie Myélome

IFM 2017-03
Hématologie Myélome
Essai clinique fermé
Public cible
A Phase 3 Study Comparing Lenalidomide and Daratumumab;Subcutaneous Injection (R-Dara SC) vs Lenalidomide and;Dexamethasone (Rd) in Frail Subjects with Previously Untreated;Multiple Myeloma who are Ineligible for High Dose Therapy.;Protocol IFM2017-03.
Description de l'essai

This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT