| TITRE |
Étude comparant le médicament à l’étude, appelé elranatamab, et l’elotuzumab, la pomalidomide et la dexaméthasone (EPd), la pomalidomide, le bortézomib et la dexaméthasone (PVd) ou le carfilzomib et la dexaméthasone (Kd) chez des personnes vivant avec un myélome multiple qui est revenu après un ou plusieurs traitements antérieurs |
| PROTOCOLE ID |
MagnetisMM-32 (C1071032) |
| CLINICAL TRIAL.gov ID |
NCT06152575 |
| TYPE(S) DE CANCER |
Myélome |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
|
| INSTITUTION |
HOPITAL DU SACRE-COEUR DE MONTREAL
5400 boul. Gouin Ouest
(514) 338-2222
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Jean-Samuel Boudreault-Pedneault
|
| COORDONATEUR(RICE) |
Maia Labelle
514-338-2222 poste 2818
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
