Description:
The purpose of this study is to confirm the safety and tolerability of elranatamab
(PF-06863135) in Japanese participants with relapsed or refractory MM.
Title
- Brief Title: MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
- Official Title: MAGNETISMM-2: A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETIC OF ELRANATAMAB (PF-06863135), A B CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA
Clinical Trial IDs
- ORG STUDY ID:
C1071002
- NCT ID:
NCT04798586
Conditions
- Relapsed or Refractory Multiple Myeloma
Interventions
Drug | Synonyms | Arms |
---|
Elranatamab (PF-06863135) | | Elranatamab (PF-06863135) |
Purpose
The purpose of this study is to confirm the safety and tolerability of elranatamab
(PF-06863135) in Japanese participants with relapsed or refractory MM.
Trial Arms
Name | Type | Description | Interventions |
---|
Elranatamab (PF-06863135) | Experimental | BCMA-CD3 bispecific antibody | - Elranatamab (PF-06863135)
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Dose Limiting Toxicity (DLT) |
Time Frame: | up to 28 days |
Safety Issue: | |
Description: | Number of participants with DLTs, which are typically Grade 3 or higher adverse events |
Secondary Outcome Measures
Measure: | frequency of treatment-emergent adverse events |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | type and severity (including severity per NCI CTCAE v5) |
Measure: | frequency of laboratory abnormalities |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5) |
Measure: | Maximum plasma concentration (Cmax) of PF-06863135 |
Time Frame: | 4 weeks |
Safety Issue: | |
Description: | Peak concentration of elranatamab (PF-06863135) |
Measure: | immunogenicity of PF-06863135 |
Time Frame: | approximately every 1 to 3 cycles (approximately 2 years) |
Safety Issue: | |
Description: | Incidence and titers of anti-drug antibodies and neutralizing antibodies against elranatamab (PF-06863135) |
Measure: | overall response rate |
Time Frame: | approximately every 3 weeks for approximately 2 years |
Safety Issue: | |
Description: | overall response rate (IMWG response criteria) |
Measure: | time to response |
Time Frame: | approximately every 3 weeks (approximately 2 years) |
Safety Issue: | |
Description: | time to response (IMWG response criteria) |
Measure: | duration of response |
Time Frame: | approximately every 3 weeks (approximately 2 years) |
Safety Issue: | |
Description: | duration of response (IMWG response criteria) |
Measure: | progression free survival |
Time Frame: | approximately every 3 weeks (approximately 2 years) |
Safety Issue: | |
Description: | progression free survival (IMWG response criteria) |
Measure: | overall survival |
Time Frame: | approximately every 3 months (approximately 2 years) |
Safety Issue: | |
Description: | overall survival |
Measure: | minimal residual disease |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | minimal residual disease (IMWG MRD criteria) |
Measure: | systemic soluble immune factors |
Time Frame: | approximately 9 months |
Safety Issue: | |
Description: | pre and post dose quantification of soluble cytokines in serum |
Measure: | 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 |
Time Frame: | 4 weeks |
Safety Issue: | |
Description: | AUC of elranatamab (PF-06863135) |
Measure: | Trough serum concentrations of PF-06863135 |
Time Frame: | approximately 2 years |
Safety Issue: | |
Description: | Trough concentrations of (PF-06863135) |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Pfizer |
Last Updated
August 23, 2021