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

Study Overview
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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.

Official Title
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A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC OF PF 06863135, A B CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA

Conditions
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Relapsed or Refractory Multiple Myeloma

Intervention / Treatment
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* Drug: Elranatamab (PF-06863135)


Participation Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elranatamab (PF-06863135)<br>BCMA-CD3 bispecific antibody | Drug: Elranatamab (PF-06863135)<br>* BCMA-CD3 bispecific antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Dose Limiting Toxicity (DLT) | Number of participants with DLTs, which are typically Grade 3 or higher adverse events | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of treatment-emergent adverse events | type and severity (including severity per NCI CTCAE v5) | approximately 2 years | 
| frequency of laboratory abnormalities | complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5) | approximately 2 years | 
| Maximum plasma concentration (Cmax) of PF-06863135 | Peak concentration of elranatamab (PF-06863135) | 4 weeks | 
| immunogenicity of PF-06863135 | Incidence and titers of anti-drug antibodies and neutralizing antibodies against elranatamab (PF-06863135) | approximately every 1 to 3 cycles (approximately 2 years) | 
| overall response rate | overall response rate (IMWG response criteria) | approximately every 3 weeks for approximately 2 years | 
| time to response | time to response (IMWG response criteria) | approximately every 3 weeks (approximately 2 years) | 
| duration of response | duration of response (IMWG response criteria) | approximately every 3 weeks (approximately 2 years) | 
| progression free survival | progression free survival (IMWG response criteria) | approximately every 3 weeks (approximately 2 years) | 
| overall survival | overall survival | approximately every 3 months (approximately 2 years) | 
| minimal residual disease | minimal residual disease (IMWG MRD criteria) | approximately 2 years | 
| systemic soluble immune factors | pre and post dose quantification of soluble cytokines in serum | approximately 9 months | 
| area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135 | AUC of elranatamab (PF-06863135) | 4 weeks | 
| Trough serum concentrations of PF-06863135 | Trough concentrations of (PF-06863135) | approximately 2 years |