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

• Status: Terminated
• Trial end date: 2019-07-17
• Target enrollment: 0
• Participant gender: All

Summary

This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.

Criteria

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.