| Titre |
An open-label, multicenter, non-randomized phase 2 study of elranatamab monotherapy in participants with multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody |
| Protocole ID |
MagnetisMM-3 |
| ClinicalTrials.gov ID |
NCT04649359 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase II |
| Type étude |
Clinique |
| Médicament |
Elranatamab |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Rayan Kaedbey
|
| Coordonnateur(trice) |
Maïka Jangal
514-340-8222 poste 24599
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
-
Measurable disease, as defined by at least 1 of the following:
- Serum M-protein >0.5 g/dL by SPEP
- Urinary M-protein excretion >200 mg/24 hours by UPEP
- Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- Refractory to at least one IMiD
- Refractory to at least one PI
- Refractory to at least one anti-CD38 antibody
- Relapsed/refractory to last anti-myeloma regimen
- Cohort A: has not received prior BCMA-directed therapy
- Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
- ECOG performance status ≤2
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
- Not pregnant and willing to use contraception
|
| Critètes d'exclusion |
- Smoldering multiple myeloma
- Active Plasma cell leukemia
- Amyloidosis
- POEMS syndrome
- Stem cell transplant within 12 weeks prior to enrollment
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
- 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.
- Previous administration with an investigational drug within 30 days 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