Overview

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.