JPRN-jRCT2031210228Active, not recruitingPhase 2
AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF PF-06863135 MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
Kawai Norisuke0 sites150 target enrollmentStarted: August 6, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
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:
- •*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)
Investigators
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