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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00525447

Collaborator

Genentech, Inc. (Industry)

Enrollment

Locations

Arm

30.1

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: SGN-40 Drug: lenalidomide Drug: dexamethasone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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. Other Names: dacetuzumab Drug: lenalidomide Up to 25 mg daily of a 21-day cycle. Other Names: Revlimid Drug: dexamethasone 40 mg administered weekly. Other Names: Decadron

Arm

Intervention/Treatment

Experimental: 1

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.

Other Names:

dacetuzumab

Drug: lenalidomide

Up to 25 mg daily of a 21-day cycle.

Other Names:

Revlimid

Drug: dexamethasone

40 mg administered weekly.

Other Names:

Decadron

Outcome Measures

Primary Outcome Measures

Adverse events and lab abnormalities. [Within 3 weeks of final infusion of SGN-40]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Cancer Center	Denver	Colorado	United States	80218
2	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
3	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
5	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
6	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
7	Weill Medical College of Cornell University	New York	New York	United States	10021
8	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
9	Baylor University Medical Center	Dallas	Texas	United States	75246