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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
Not Enrolling
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

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:


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:


Principal Investigator

Nancy Whiting, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.


United States: Food and Drug Administration

Study ID:




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



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