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

Multiple Myeloma Clinical Trial

Official title:

A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525447
• Other study ID #: SG040-0006
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2007
• Last updated: October 7, 2014
• Start date: August 2007
• Est. completion date: February 2010

Study information

• Verified date: October 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• SGN-40
2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.
• lenalidomide
Up to 25 mg daily of a 21-day cycle.
• dexamethasone
40 mg administered weekly.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Baylor University Medical Center	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Weill Medical College of Cornell University	New York	New York
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and lab abnormalities.		Within 3 weeks of final infusion of SGN-40	Yes
Secondary	Best clinical response, progression-free survival, and overall survival.		Study duration	No
Secondary	PK profile.		Within 3 weeks of final infusion of SGN-40	No
Secondary	Anti-drug antibody immune responses.		Within 3 weeks of final infusion of SGN-40	Yes