A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

• Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG] ).
• Age 18 years or older.
• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Life expectancy greater than 3 months.
• Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
• Measurable disease, as defined by at least one of the following: Serum M protein 0.5 g/dL or higher, Urine M protein 200 mg/24 hr or higher, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal SFLC ratio.
• Adequate hematologic, renal, and hepatic function
• A negative pregnancy test (for females of childbearing potential).
• Patients must provide written informed consent.

Exclusion Criteria:

• Other invasive malignancy within the past 3 years.
• Active cerebral/meningeal disease related to the underlying malignancy.
• Active Grade 3 or higher infection.
• Known to be positive for HIV or known to have active hepatitis B or C.
• Previous allogeneic stem cell transplant.
• Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
• Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
• Females who are pregnant or breastfeeding.