| Titre |
A Randomized, 2-Arm, Phase 3 Study of Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease-Positive After Undergoing Autologous Stem-Cell Transplantation |
| Protocole ID |
MagnetisMM-7 (C1071007) |
| ClinicalTrials.gov ID |
NCT05317416 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Elranatamab versus lénalidomide |
| Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Richard Leblanc
|
| Coordonnateur(trice) |
Nathalie Lachapelle
514-252-3400 poste 4471
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
- Partial Response or better according to IMWG criteria at the time of randomization
- MRD positive (≥10^-5) at screening by central laboratory NGS test (ClonoSEQ assay) Must have an archival bone marrow aspirate sample(s) that identified the dominant malignant (index) clone that is used to track MRD status. This sample sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
- ECOG performance status ≤1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
- Not pregnant and willing to use contraception
|
| Critètes d'exclusion |
- Plasma cell leukemia
- Amyloidosis, Waldenström's macroglobulinemia
- POEMS syndrome
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- Previous MM maintenance treatment
- Prior treatment with BCMA targeted therapy
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
- Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
|
Groupe d'étude en oncologie du Québec