relapsed/refractory multiple myeloma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014) *Measurable disease, as defined by at least 1 of the following: 1.Serum M-protein >0.5 g/dL by SPEP 2.Urinary M-protein excretion >200 mg/24 hours by UPEP 3.Serum immunoglobulin FLC>=10 mg/dL (>=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio *Refractory to at least one IMiD *Refractory to at least one PI *Refractory to at least one anti-CD38 antibody *Relapsed/refractory to last anti-myeloma regimen *Cohort A: has not received prior BCMA-directed therapy *Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells) *ECOG performance status <=2 *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: *Smoldering multiple myeloma *Active Plasma cell leukemia *Amyloidosis *POEMS syndrome *Stem cell transplant within 12 weeks prior to enrollment *Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection *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. *Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures : 1.objective response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures : 1.duration of response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 2.cumulative complete response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 3.duration of cumulative complete response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 4.progression free survival [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 5.time to response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ] 6.minimal residual disease negativity rate [ Time Frame: assessed approximately every 12 months [up to approximately 2 years] ] 7.frequency of treatment-emergent adverse events [ Time Frame: up to approximately 2 years ] 8.frequency of laboratory abnormalities [ Time Frame: assessed at least approximately every cycle [each cycle approximately 28 days] ] 9.concentrations of PF-0683135 [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ] 10.immunogenicity of PF-0683135 [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ] 11.overall survival [ Time Frame: at least approximately 2 years ] | — |
Countries
Australia, Belgium, Canada, France, Germany, Japan, Poland, Spain, United Kingdom, United States
Contacts
Pfizer R&D Japan G.K.