Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.

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

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Collaborator: Genentech, Inc.
• Treatments: Antibodies; BB 1101; Dacetuzumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Diagnosis of multiple myeloma.

• Received at least one prior systemic therapy other than single-agent corticosteroids.

• Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free light chain (FLC) in serum as determined by serum FLC assay and provided the serum FLC ratio is abnormal.

Exclusion Criteria:

• Received an allogenic stem cell transplant.

• Previous intolerance of lenalidomide or dexamethasone.

• Primary invasive malignancy (other than multiple myeloma) within the last 3 years.