MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

Korábbi kezelés

• Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
• Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
• Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
• Sub-Study A Only: Previous treatment with BCMA bispecific antibody
• Sub-Study B Only: Previous treatment with BCMA directed therapy

Más betegség

• POEMS syndrome
• Any active uncontrolled bacterial, fungal, or viral infection

Egyéb

• Active plasma cell leukemia
• Amyloidosis

• Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
• Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
• Measurable disease defined by at least one 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
• ECOG performance status 0 -1
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade </= 1