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

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: SGN-40; Drug: lenalidomide; Drug: dexamethasone

• Registration Number: NCT00525447
• Lead Sponsor: Seagen Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	lenalidomide	-
1	SGN-40	-
1	dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Adverse events and lab abnormalities.	Within 3 weeks of final infusion of SGN-40

Secondary Outcome Measures

Name	Time	Method
Best clinical response, progression-free survival, and overall survival.	Study duration
PK profile.	Within 3 weeks of final infusion of SGN-40
Anti-drug antibody immune responses.	Within 3 weeks of final infusion of SGN-40

Trial Locations

Locations (9)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Nebraska Methodist Hospital; 🇺🇸 Omaha, Nebraska, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States