jRCT2021210002CompletedNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer Japan Inc.
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- All
Inclusion 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
- •PS 3 is permitted if PS is due solely to bone pain
- •Adequate bone marrow, 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
- •Exclusion Criteria:
- •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
- •Major surgery within 4 weeks prior to study entry
- •Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
- •Radiation therapy within 2 weeks prior to study entry
- •History of active autoimmune disorders
- •Any form of primary immunodeficiency
- •History of severe immune-mediated adverse event with prior immunomodulatory treatment
- •Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
- •Requirement for systemic immune suppressive medication
- •Participant known to be refractory to platelet or red blood cell transfusions
- •Current requirement for chronic blood product support
- •Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
- •Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- •Clinically significant cardiovascular in the previous 6 months
- •Hypertension that cannot be controlled by medications
- •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 PF 06863135, murine and bovine products
Investigators
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