Status:
COMPLETED
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
Lead Sponsor:
Pfizer
Conditions:
Relapsed or Refractory Multiple Myeloma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.
Eligibility Criteria
Inclusion
- Diagnosis of multiple myeloma (IMWG criteria)
- Measurable disease, as defined by at least 1 of the following
- Serum myeloma (M) protein ≥0.5 g/dL (5 g/L)
- Urine M protein ≥200 mg/24 h
- Serum free light chain (FLC) \>100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio
- Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
- ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain
- Adequate bone marrow, hematological, kidney and liver function
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
- Not pregnant and willing to use contraception
Exclusion
- POEMS syndrome
- 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
- History of active autoimmune disorders
- Any form of primary immunodeficiency
- History of severe immune-mediated adverse event with prior immunomodulatory treatment
- Stem cell transplant within 12 weeks prior to enrollment
- Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
- Requirement for systemic immune suppressive medication
- Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
- Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
- Known or suspected hypersensitivity to component of elranatamab (PF-06863135), murine and bovine products
- Live attenuated vaccine within 4 weeks
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04798586
Start Date
March 22 2021
End Date
May 17 2023
Last Update
September 27 2024
Active Locations (2)
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1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
2
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan, 150-8935