| Titre |
A phase 3, open-label study of elranatamab monotherapy versus elotuzumab, pomalidomide, dexamethasone (epd) or pomalidomide, bortezomib, dexamethasone (pvd) or carfilzomib, dexamethasone (kd) in participants with relapsed/refractory multiple myeloma who received prior anti-cd38 directed therapy |
| Protocole ID |
MagnetisMM-32 (C1071032) |
| ClinicalTrials.gov ID |
NCT06152575 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase III |
| Institution |
CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL
 HOPITAL DU SACRE-COEUR-DE-MONTREAL
5400 boul. Gouin Ouest, Montréal, QC, H4J1C5
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Jean-Samuel Boudreault-Pedneault
|
| Coordonnateur(trice) |
Maia Labelle
514-338-2222 poste 2818
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
- Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
- Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Have clinical laboratory values within the specified range.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- Not pregnant or breastfeeding and willing to use contraception.
|
| Critètes d'exclusion |
- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
- Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
- Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
- Unable to receive investigator's choice therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
|
Groupe d'étude en oncologie du Québec