MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

Korábbi kezelés

• Stem cell transplant within 12 weeks prior to enrollment
• 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)

Más betegség

• POEMS syndrome
• Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection

Egyéb

• Smoldering multiple myeloma
• Active Plasma cell leukemia
• Amyloidosis

• Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
• Measurable disease, as defined by at least 1 of the following:
  • Serum M-protein >0.5 g/dL by SPEP
  • Urinary M-protein excretion >200 mg/24 hours by UPEP
  • 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