Cevostamab in Combination with Pomalidomide and Dexamethasone Versus Standard of Care in Patients with Previously Treated Multiple Myeloma

Other illness

• Waldenström’s macroglobulinemia or POEMS syndrome
• Known history of interstitial lung disease

Lab values

• Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
• Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/µL or 5% of the peripheral blood white cells

Other

• Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
• Inability to tolerate thromboprophylaxis, or contraindication to thromboprophylaxis

• Willing to undergo scheduled assessments and procedures including bone marrow biopsy and aspirate samples.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment. Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
• Life expectancy of at least 12 weeks
• MM diagnosis according to the IMWG diagnostic criteria
• Measurable disease defined as at least one of the following by central laboratory assessment – Serum M-protein ≥ 0.5 g/dL (≥ 5 g/L) – Urine M-protein ≥ 200 mg/24 h – Light chain MM without measurable M-protein in serum or urine: serum immunoglobulin free light chain > 10 mg/dL and abnormal serum immunoglobulin kappa-lambda free light chain ratio < 0.26 or > 1.65
• Received one to three lines of prior therapy (for guidelines to determine prior lines of therapy, see Section 12.14) that included at least two consecutive cycles of either of the following: – A regimen containing an anti-CD38 therapy, and - A regimen containing lenalidomide, and – For the United States: a regimen containing a PI – For countries outside the United States, a regimen containing a PI is allowed but not mandated