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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2023-05-17

Brief Summary

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

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Detailed Description

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Conditions

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Relapsed or Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elranatamab (PF-06863135)

BCMA-CD3 bispecific antibody

Group Type EXPERIMENTAL

Elranatamab (PF-06863135)

Intervention Type DRUG

BCMA-CD3 bispecific antibody

Interventions

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Elranatamab (PF-06863135)

BCMA-CD3 bispecific antibody

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No