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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Adverse events and lab abnormalities.

Outcome Time Frame:

Within 3 weeks of final infusion of SGN-40

Safety Issue:

Yes

Principal Investigator

Nancy Whiting, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG040-0006

NCT ID:

NCT00525447

Start Date:

August 2007

Completion Date:

February 2010

Related Keywords:

  • Multiple Myeloma
  • 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
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Avera Cancer Institute Sioux Falls, South Dakota  57105
Hackensack University Medical Center Hackensack, New Jersey  07601
Weill Medical College of Cornell University New York, New York  10021
Rocky Mountain Cancer Center Denver, Colorado  80218
Baylor University Medical Center Dallas, Texas  75246
Nebraska Methodist Hospital Omaha, Nebraska  68114
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Dana Farber Cancer Institute Boston, Massachusetts  02115