Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant (MagnetisMM-7)

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Full Title:
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
Myeloma stage or condition:
Multiple Myeloma
Study phase:
Phase 3
Summary/Purpose:
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
Detailed Description:
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.
Treatments:
Drug : Elranatamab

BCMA-CD3 bispecific antibody

Drug : Lenalidomide

Immunomodulatory drug

Drug : Lenalidomide

Immunomodulatory drug

Drug : Elranatamab

BCMA-CD3 bispecific antibody

Study Arms:
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
Study Type:
Interventional
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Recruitment status:
Recruiting
Eligibility criteria:
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
Exclusion Criteria:
  • 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)
Locations / Centres:

Tom Baker Cancer Center, Calgary, Alberta – Recruiting

Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick – Recruiting

Saint John Regional Hospital, Saint John, New Brunswick – Recruiting

Hamilton Health Sciences Corporation, Hamilton, Ontario – Recruiting

Princess Margaret Cancer Centre, Toronto, Ontario – Recruiting

Windsor Regional Hospital Cancer Program, Windsor, Ontario – Not yet recruiting

Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,, Montreal, Quebec – Recruiting

McGill University Health Centre, Montreal, Quebec – Recruiting

Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSS, Montreal, Quebec – Recruiting

Contacts:
Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
Publications:
???
First posted:
2022-04-07
Actual start date:
March 25, 2022
Last updated:
2024-04-10
Estimated enrollment:
760
Estimated completion date:
2029-10-31
Estimated primary completion date:
2027-08-04
Condition:
Multiple Myeloma
Gender:
All
Ages:
18 Years-N/A
Accepts healthy volunteers:
No
Listed location countries:
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 States
NCT number:
NCT05317416
Other study ID numbers:
C1071007
Has Data monitoring committee:
Yes
U.S. FDA-regulated product:
Yes
IPD Sharing Statement :
???
Responsible party:
Sponsor
Study sponsor:
lead_sponsor
Pfizer
Industry
Collaborators:
???
Investigators:
Pfizer CT.gov Call Center Pfizer
Protocol Registration and Results System:
???
Verification date:
2024-04-01