Condition: Multiple Myeloma, Newly Diagnosed · Sponsor: Intergroupe Francophone du Myelome
This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT. 824 patients will be enrolled in this study from approximately 70 study sites. The 2 parts in the Treatment Phase are described below. Part 1: Induction/ASCT/Consolidation Phase (1:1 Randomization) After the screening period, patients will be randomly allocated (1:1) to either: * Arm A (standard of care arm): standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, D-VRd consolidation therapy * Arm B (experimental arm): standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy. Part 2: Maintenance Phase (1:1 Re-randomization) Patients will be re-randomized (1:1) and will enter the Maintenance Phase upon completion of consolidation therapy. • Arm C (standard of care arm): daratumumab + lenalidomide approx 2 years. Subjects with a negative MRD (for at least 12 months) after 24 cycles of daratumumab-lenalidomide will discontinue daratumumab and continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first). Subjects who did not achieve MRD negativity for at least 12 months after 24 cycles of daratumumab-lenalidomide will continue to receive daratumumab-lenalidomide until: * MRD negativity for at least 12 months is reached. Subjects will then continue with lenalido…
This description comes directly from the study's public registry record.
Léa Tabone, PharmD · 0140212404 · l.tabone@myelome.fr
Always discuss trial participation with your own doctor first.
| CHU Amiens | Amiens, France | Recruiting |
| CHU Angers | Angers, France | Recruiting |
| Ch Annecy Genevois | Annecy, France | Recruiting |
| Centre Hospitalier d'Argenteuil Victor Dupouy | Argenteuil, France | Recruiting |
| Centre Hospitalier H. Duffaut | Avignon, France | Recruiting |
| Centre hospitalier de la Côte Basque | Bayonne, France | Recruiting |
| CHU Besançon | Besançon, France | Recruiting |
| Centre Hospitalier Simone Veil | Blois, France | Not Yet Recruiting |
| Hôpital Avicenne | Bobigny, France | Recruiting |
| CHU Bordeaux - Hopital Haut Lévêque - Centre F. Magendi | Bordeaux, France | Recruiting |
| CH Fleyriat | Bourg-en-Bresse, France | Recruiting |
| CHRU Brest - Hôpital A. Morvan | Brest, France | Recruiting |
+ 52 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06918002