MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma

Pfizer

Status and phase: Completed; Phase 1

Conditions: Relapsed or Refractory Multiple Myeloma

Treatments: Drug: Elranatamab (PF-06863135)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04798586

C1071002

Details and patient eligibility

About

The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.

Enrollment: 4 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Elranatamab (PF-06863135)

Experimental group

Description:

BCMA-CD3 bispecific antibody

Treatment:

Drug: Elranatamab (PF-06863135)