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

Seagen

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: lenalidomide; Drug: SGN-40; Drug: dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00525447

SG040-0006

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

1

Experimental group

Treatment:

Drug: dexamethasone

Drug: SGN-40

Drug: lenalidomide