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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525447
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : October 9, 2014
Genentech, Inc.
Information provided by (Responsible Party):
Seattle Genetics, 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: SGN-40 Drug: lenalidomide Drug: dexamethasone Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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 : August 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

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 Name: dacetuzumab
Drug: lenalidomide
Up to 25 mg daily of a 21-day cycle.
Other Name: Revlimid
Drug: dexamethasone
40 mg administered weekly.
Other Name: Decadron

Primary Outcome Measures :
  1. Adverse events and lab abnormalities. [ Time Frame: Within 3 weeks of final infusion of SGN-40 ]

Secondary Outcome Measures :
  1. Best clinical response, progression-free survival, and overall survival. [ Time Frame: Study duration ]
  2. PK profile. [ Time Frame: Within 3 weeks of final infusion of SGN-40 ]
  3. Anti-drug antibody immune responses. [ Time Frame: Within 3 weeks of final infusion of SGN-40 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525447

United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech, Inc.
Study Director: Nancy Whiting, PharmD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc. Identifier: NCT00525447     History of Changes
Other Study ID Numbers: SG040-0006
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD40
Antibodies, Monoclonal
Combined Modality Therapy
Multiple Myeloma
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immunoproliferative Disorders
Lymphoproliferative Disorders
Vascular Diseases
Antibody-Dependent Cell Cytotoxicity

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal