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MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
CompletedPhase 1
Sponsor: Pfizer
Conditions: Relapsed or Refractory Multiple Myeloma
Interventions: Elranatamab (PF-06863135)
Countries: Japan
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 overview
Sex: ALL
Age: 20 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Diagnosis of multiple myeloma (IMWG criteria) * Measurable disease, as defined by at least 1 of the following 1. Serum myeloma (M) protein ≥0.5 g/dL (5 g/L) 2. Urine M protein ≥200 mg/24 h 3. 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 Criteria: * 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
Locations (2)
- Nagoya, Aichi-ken, Japan
- Shibuya-ku, Tokyo, Japan