Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant (MagnetisMM-7)
*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 RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION
- Stade ou Condition:
- Multiple Myeloma
- Phase d'étude:
- Phase 3
- Résumé:
- The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
- Description détaillée:
- Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
- Traitements:
- Drug : Elranatamab
BCMA-CD3 bispecific antibody
- Drug : Lenalidomide
Immunomodulatory drug
- Drug : Lenalidomide
Immunomodulatory drug
- Drug : Elranatamab
BCMA-CD3 bispecific antibody
- Groupes d'étude:
- Experimental : Arm A - Part 1
Elranatamab - Active Comparator : Arm B - Part 1
Lenalidomide - Active Comparator : Arm B - Part 2
Lenalidomide - Experimental : Arm C - Part 2
Elranatamab
- Type d'étude:
- Interventional
- Protocole de l'étude:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Statut du recrutement:
- En cours
- Critères d'admissibilités:
-
Inclusion Criteria:
- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
- Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
- 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
- Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This 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
- 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)
- Lieux / Centres:
-
Tom Baker Cancer Center, Calgary, Alberta – En cours
Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick – En cours
Saint John Regional Hospital, Saint John, New Brunswick – En cours
Hamilton Health Sciences Corporation, Hamilton, Ontario – En cours
Princess Margaret Cancer Centre, Toronto, Ontario – En cours
Windsor Regional Hospital Cancer Program, Windsor, Ontario – À venir
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,, Montreal, Quebec – En cours
McGill University Health Centre, Montreal, Quebec – En cours
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSS, Montreal, Quebec – En cours
- Contacts:
- Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
- Publications:
- ???
- Date d’affichage:
- 2022-04-07
- Date de début:
- March 25, 2022
- Dernière mise à jour:
- 2024-05-06
- Nombre d'inscriptions anticipées:
- 760
- Date de fin prévue:
- 2029-10-31
- Date de fin prévue de l'étude primaire:
- 2027-08-04
- Condition:
- Multiple Myeloma
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Czechia
- Finland
- France
- Germany
- Greece
- Hungary
- India
- Israel
- Italy
- Japan
- Korea, Republic of
- Netherlands
- Norway
- Poland
- Spain
- Sweden
- Taiwan
- Turkey
- United Kingdom
- United States
- Numéro d’identification:
- NCT05317416
- Autres numéros d'identification de l'étude:
- C1071007
- Comité de suivi des données:
- Yes
- 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