Relapsed or Refractory Multiple Myeloma Clinical Trial
Official title:
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
Verified date | June 2022 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.
Status | Active, not recruiting |
Enrollment | 4 |
Est. completion date | May 20, 2023 |
Est. primary completion date | May 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Nagoya City University Hospital | Nagoya | Aichi |
Japan | Japanese Red Cross Medical Center | Shibuya-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | frequency of treatment-emergent adverse events | type and severity (including severity per NCI CTCAE v5) | approximately 2 years | |
Secondary | frequency of laboratory abnormalities | complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5) | approximately 2 years | |
Secondary | Maximum plasma concentration (Cmax) of PF-06863135 | Peak concentration of elranatamab (PF-06863135) | 4 weeks | |
Secondary | 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) | |
Secondary | overall response rate | overall response rate (IMWG response criteria) | approximately every 3 weeks for approximately 2 years | |
Secondary | time to response | time to response (IMWG response criteria) | approximately every 3 weeks (approximately 2 years) | |
Secondary | duration of response | duration of response (IMWG response criteria) | approximately every 3 weeks (approximately 2 years) | |
Secondary | progression free survival | progression free survival (IMWG response criteria) | approximately every 3 weeks (approximately 2 years) | |
Secondary | overall survival | overall survival | approximately every 3 months (approximately 2 years) | |
Secondary | minimal residual disease | minimal residual disease (IMWG MRD criteria) | approximately 2 years | |
Secondary | systemic soluble immune factors | pre and post dose quantification of soluble cytokines in serum | approximately 9 months | |
Secondary | 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 | |
Secondary | Trough serum concentrations of PF-06863135 | Trough concentrations of (PF-06863135) | approximately 2 years |
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