MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
*Les informations de l'essai contenues sur cette page ont été récupérées du site ClinicalTrials.gov. Cliquez ici pour voir cet essai sur ClinicalTrials.gov.
- Titre complet:
- A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA
- Stade ou Condition:
- Multiple Myeloma
- Phase d'étude:
- Phase 2
- Résumé:
- The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.
- Description détaillée:
- Non disponible
- Traitements:
- Drug : Elranatamab + Nirogacestat
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
- Drug : Elranatamab + lenalidomide + dexamethasone
BCMA-CD3 bispecific antibody + immunomodulatory
- Groupes d'étude:
- Experimental : Sub-Study A
BCMA-CD3 bispecific antibody + gamma secretase inhibitor - Experimental : Sub-Study B
BCMA-CD3 bispecific antibody + immunomodulatory drug
- Type d'étude:
- Interventional
- Protocole de l'étude:
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Statut du recrutement:
- En cours
- Critères d'admissibilités:
-
Inclusion Criteria:
- Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
- Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
- Measurable disease defined by at least one of the following: 1. Serum M-protein >/= 0.5 g/dL by SPEP 2. Urinary M-protein excretion >/= 200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC >/= 10 mg/dL (>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- ECOG performance status 0 -1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade
- Active plasma cell leukemia
- Amyloidosis
- Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
- POEMS syndrome
- Any active uncontrolled bacterial, fungal, or viral infection
- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
- Sub-Study A Only: Previous treatment with BCMA bispecific antibody
- Sub-Study B Only: Previous treatment with BCMA directed therapy
- Lieux / Centres:
-
Tom Baker Cancer Center, Calgary, Alberta – En cours
The Ottawa Hospital - General Campus, Ottawa, Ontario – En cours
Princess Margaret Cancer Centre, Toronto, Ontario – En cours
- Contacts:
- Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
- Publications:
- ???
- Date d’affichage:
- 2021-10-25
- Date de début:
- October 27, 2021
- Dernière mise à jour:
- 2024-04-11
- Nombre d'inscriptions anticipées:
- 120
- Date de fin prévue:
- 2027-07-02
- Date de fin prévue de l'étude primaire:
- 2025-08-16
- Condition:
- Multiple Myeloma
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Canada
- United States
- Numéro d’identification:
- NCT05090566
- Autres numéros d'identification de l'étude:
- C1071004
- Comité de suivi des données:
- No
- Produit réglementé par la FDA (É-U):
- Yes
- IPD Sharing Statement :
- ???
- Responsables de l’étude:
-
Sponsor
- Commanditaires de l’étude:
- lead_sponsor
Pfizer
Industry
- Collaborators:
- ???
- Chercheurs:
- Pfizer CT.gov Call Center Pfizer
- Protocol Registration and Results System:
- ???
- Date de vérification:
- 2024-04-01