Les informations présentées dans l’Outil de recherche personnalisé d’essais cliniques de Myélome Canada sont issues de la base de données des essais cliniques internationaux du site
ClinicalTrials.gov,
répertoriées par la U.S. National Library of Medicine. Bien que le menu soit en français, les détails des études ne sont offerts qu’en anglais.
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant (MagnetisMM-6)
*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:
- MAGNETISMM-6: AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA
- Stade ou Condition:
- Multiple Myeloma
- Phase d'étude:
- Phase 3
- Résumé:
- 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. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab when administered in combination with daratumumab and lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.
- Description détaillée:
- Non disponible
- Traitements:
- Drug : Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
- Drug : Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
- Drug : Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
- Drug : Dexamethasone
Randomized
- Groupes d'étude:
- Experimental : Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
- Experimental : Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
- Experimental : Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
- Active Comparator : Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone
- 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 multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL;
- Urinary M-protein excretion ≥200 mg/24 hours;
- Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
- Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant
- ECOG performance status ≤2.
- Not pregnant and willing to use contraception
- For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Smoldering Multiple Myeloma.
- Monoclonal gammopathy of undetermined significance.
- Waldenströms Macroglobulinemia
- Plasma cell leukemia.
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
- For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
- For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention).
- Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
- Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
- Lieux / Centres:
-
QEII Health Sciences Centre, Halifax, Nova Scotia – 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:
- 2022-11-21
- Date de début:
- November 10, 2022
- Dernière mise à jour:
- 2024-04-15
- Nombre d'inscriptions anticipées:
- 966
- Date de fin prévue:
- 2031-11-29
- Date de fin prévue de l'étude primaire:
- 2028-03-31
- Condition:
- Multiple Myeloma
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Australia
- Canada
- Czechia
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Korea, Republic of
- Poland
- Spain
- Taiwan
- Numéro d’identification:
- NCT05623020
- Autres numéros d'identification de l'étude:
- C1071006
- 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