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MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (MAGNETISMM-5)

*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.

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Titre complet:
AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 3
Résumé:
The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
Description détaillée:
Non disponible
Traitements:
Drug : Elranatamab

subcutaneous

Drug : Daratumumab

Daratumumab / hyaluronidase, subcutaneous

Drug : Pomalidomide

oral

Drug : Dexamethasone

oral

Groupes d'étude:
Experimental : Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
Experimental : Part 2 Randomized Arm A: Elranatamab
Experimental : Part 2 Randomized Arm B: Elranatamab + Daratumumab
Active Comparator : Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)
Statut du recrutement:
En cours
Critères d'admissibilités:
Inclusion Criteria:
  • Prior diagnosis of multiple myeloma 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.
  • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
  • ECOG performance status ≤2.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  • Not pregnant and willing to use contraception.
Exclusion Criteria:
  • Smoldering multiple myeloma.
  • Plasma cell leukemia.
  • Amyloidosis.
  • POEMS Syndrome.
  • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
  • Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Previous treatment with a BCMA-directed therapy.
  • Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Lieux / Centres:

Tom Baker Cancer Center, Calgary, Alberta – Recrutement inactif

Cross Cancer Institute, Edmonton, Alberta – Recrutement inactif

QEII Health Sciences Centre - Victoria General Site, Halifax, Nova Scotia – Recrutement inactif

Queen Elizabeth II Health Science Centre, Halifax, Nova Scotia – Recrutement inactif

Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Ontario – Recrutement inactif

Princess Margaret Cancer Centre, Toronto, Ontario – Recrutement inactif

Jewish General Hospital, Montreal, Quebec – Recrutement inactif

CIUSSS de l'Est-de-l'Île-de-Montréal, Montréal, Quebec – Recrutement inactif

Saskatoon Cancer Center, Saskatoon, Saskatchewan – Recrutement inactif

Contacts:
Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
Publications:
???
Date d’affichage:
2021-08-25
Date de début:
October 4, 2021
Dernière mise à jour:
2024-03-08
Nombre d'inscriptions anticipées:
762
Date de fin prévue:
2026-09-28
Date de fin prévue de l'étude primaire:
2024-12-27
Condition:
Multiple Myeloma
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czechia
Finland
France
Germany
Greece
Italy
Japan
Korea, Republic of
Mexico
Netherlands
New Zealand
Norway
Poland
Spain
Sweden
Taiwan
Turkey
United Kingdom
United States
Numéro d’identification:
NCT05020236
Autres numéros d'identification de l'étude:
C1071005
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:
2024-03-01