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A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

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Titre complet:
A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 1
Résumé:
The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: - their disease progresses or, - they experience unacceptable side effects or, - they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.
Description détaillée:
Non disponible
Traitements:
Drug : Elranatamab

BCMA-CD3 bispecific antibody

Drug : Iberdomide

cereblon-modulating agent

Groupes d'étude:
Experimental : Part 1 Dose Escalation
Non-randomized elranatamab plus iberdomide
Experimental : Part 2 Dose Randomization
Randomized elranatamab plus iberdomide
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
En cours
Critères d'admissibilités:
Inclusion Criteria:
  • Prior diagnosis of multiple myeloma as defined by IMWG criteria
  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL by SPEP
  • Urinary M-protein excretion ≥200 mg/24 hour by UPEP
  • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (<0.26 or >1.65)
  • Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  • Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  • ECOG performance status 0-1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
Exclusion Criteria:
  • Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
  • Participants with any active, uncontrolled bacterial, fungal, or viral infection
  • 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
  • Previous treatment with:
  • BCMA-directed or CD3 redirecting therapy
  • Iberdomide (CC-220) or Mezigdomide
  • Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
  • Administration with an investigational product within 30 days preceding the first dose of study intervention
  • Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis
Lieux / Centres:

Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick – En cours

Contacts:
Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
Publications:
???
Date d’affichage:
2024-01-22
Date de début:
February 20, 2024
Dernière mise à jour:
2024-04-12
Nombre d'inscriptions anticipées:
100
Date de fin prévue:
2028-03-09
Date de fin prévue de l'étude primaire:
2027-04-10
Condition:
Multiple Myeloma
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Canada
United States
Numéro d’identification:
NCT06215118
Autres numéros d'identification de l'étude:
C1071030
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:
collaborator
Bristol-Myers Squibb
Industry
lead_sponsor
Pfizer
Industry
Collaborators:
???
Chercheurs:
Pfizer CT.gov Call Center Pfizer
Protocol Registration and Results System:
???
Date de vérification:
2024-04-01