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

Sponsors and Collaborators:	Seattle Genetics, Inc. Genentech
Information provided by:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00525447

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: SGN-40 Drug: lenalidomide Drug: dexamethasone	Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Bleeding Disorders Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Immunoglobulins Globulin, Immune Lenalidomide CC 5013 Dacetuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Adverse events and lab abnormalities. [ Time Frame: Within 3 weeks of final infusion of SGN-40 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Best clinical response, progression-free survival, and overall survival. [ Time Frame: Study duration ] [ Designated as safety issue: No ]
PK profile. [ Time Frame: Within 3 weeks of final infusion of SGN-40 ] [ Designated as safety issue: No ]
Anti-drug antibody immune responses. [ Time Frame: Within 3 weeks of final infusion of SGN-40 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	38
Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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. Drug: lenalidomide Up to 25 mg daily of a 21-day cycle. Drug: dexamethasone 40 mg administered weekly.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525447

Contacts

Contact: Terri Lowe

866-333-7436

clinicaltrials@seagen.com

Locations

United States, Colorado
Rocky Mountain Cancer Center	Recruiting
Denver, Colorado, United States, 80218
Principal Investigator: Jeffrey Matous, MD
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute	Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Mohamad Hussein, MD
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Nikhil Munshi, MD
United States, Michigan
Barbara Ann Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Jeffrey Zonder, MD
United States, New York
Weill Medical College of Cornell University	Recruiting
New York, New York, United States, 10021
Principal Investigator: Ruben Niesvizky, MD
United States, South Dakota
Avera Cancer Institute	Recruiting
Sioux Falls, South Dakota, United States, 57105
Principal Investigator: R. Vinod Parameswaran, MD
United States, Texas
Baylor University Medical Center	Recruiting
Dallas, Texas, United States, 75426
Principal Investigator: Edward Agura, MD

Sponsors and Collaborators

Seattle Genetics, Inc.

Genentech

Investigators

Study Director:

Nancy Whiting, PharmD

Seattle Genetics, Inc.

More Information

Responsible Party:	Seattle Genetics, Inc. ( Nancy Whiting, PharmD )
Study ID Numbers:	SG040-0006
Study First Received:	August 31, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00525447
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Paraproteinemias
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

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Multiple Myeloma
Antibodies, Monoclonal
Antibodies
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Immunoglobulins
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics

Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009