Overview

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.