Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Drug: PF-06863135
BCMA-CD3 bispecific antibody
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
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 2. 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures : 1.Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: up to 28 days ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures : 1.frequency of treatment-emergent adverse events [ Time Frame: approximately 2 years ] 2.frequency of laboratory abnormalities [ Time Frame: approximately 2 years ] 3.Maximum plasma concentration (Cmax) of PF-06863135 [ Time Frame: 4 weeks ] 4.immunogenicity of PF-06863135 [ Time Frame: approximately every 1 to 3 cycles (approximately 2 years) ] 5.overall response rate [ Time Frame: approximately every 3 weeks for approximately 2 years ] 6.time to response [ Time Frame: approximately every 3 weeks (approximately 2 years) ] 7.duration of response [ Time Frame: approximately every 3 weeks (approximately 2 years) ] 8.progression free survival [ Time Frame: approximately every 3 weeks (approximately 2 years) ] 9.overall survival [ Time Frame: approximately every 3 months (approximately 2 years) ] 10.minimal residual disease [ Time Frame: approximately 2 years ] 11.systemic soluble immune factors [ Time Frame: approximately 9 months ] 12.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 ] 13.Trough serum concentrations of PF-06863135 [ Time Frame: approximately 2 years ] | — |
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed