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

Sponsor:	Seattle Genetics, Inc.
Collaborator:	Genentech
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Bleeding Disorders Cancer Multiple Myeloma Vascular Diseases

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Lenalidomide CC 5013 Dacetuzumab Dexamethasone Sodium Phosphate

U.S. FDA Resources

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
Study Completion Date:	February 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Locations

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

Investigators

Study Director:

Nancy Whiting, PharmD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00525447 History of Changes
Other Study ID Numbers:	SG040-0006
Study First Received:	August 31, 2007
Last Updated:	October 7, 2011
Health Authority:	United States: Food and Drug Administration

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
Paraproteinemias
Vascular Diseases
Antibody-Dependent Cell Cytotoxicity

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate

Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 02, 2012