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Study of SGN-40 in Patients With Refractory or Recurrent 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: NCT00079716
Recruitment Status : Completed
First Posted : March 16, 2004
Last Update Posted : December 18, 2014
Genentech, Inc.
Information provided by:
Seattle Genetics, Inc.

Brief Summary:
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: SGN-40 (anti-huCD40 mAb) Phase 1

Detailed Description:

This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma.

A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be 16mg/kg.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma
Study Start Date : March 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: 1 Drug: SGN-40 (anti-huCD40 mAb)
0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
Other Name: dacetuzumab

Primary Outcome Measures :
  1. Adverse events and lab abnormalities.

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients must have refractory or recurrent secretory multiple myeloma (MM).
  2. Patients must have failed at least two different prior systemic therapies for MM.
  3. Patients may have received a maximum of five cytotoxic regimens.
  4. Patients who have received any of the following must complete within the specified time frame below:

    • Autologous stem cell transplant - 12 weeks prior to first dose
    • Nitrogen Mustard agents, Melphalan, BCNU, IVIG, or monoclonal antibody therapy - 6 weeks prior to first dose
    • Chemotherapy, Radiation, or other therapies for MM - 4 weeks prior to first dose
  5. Patients who have not undergone autologous stem cell transplantation must be either ineligible for stem cell transplantation or, if eligible, must have refused treatment by autologous stem cell transplantation.
  6. Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three months.
  7. Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution for the entire duration of the study.
  8. Patients must be at least 18 years of age.
  9. Females of childbearing potential must have a negative β-HCG pregnancy test result within three days of enrollment. All patients must plan to use an effective contraceptive method during the course of the study.
  10. Patients must meet baseline lab data requirements.
  11. Patients must give written informed consent.

Exclusion Criteria:

  1. Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.
  2. Patients with a history of allogeneic transplantation.
  3. Patients receiving plasmapheresis within four weeks prior to enrollment.
  4. Patients undergoing major surgery within four weeks prior to enrollment.
  5. Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  6. Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ.
  7. Patients with any active viral, bacterial, or systemic fungal infection within four weeks of enrollment.
  8. Patients with a history of significant chronic or recurrent infections requiring treatment.
  9. Patients with a history of active thrombosis within three months of enrollment.
  10. Patients with a history of pulmonary embolism.
  11. Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
  12. Patients who are pregnant or breastfeeding.
  13. Patients with uncontrolled hypercalcemia.
  14. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
  15. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.

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): NCT00079716

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United States, California
James R. Berenson M.D., Inc.
West Hollywood, California, United States, 90069
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Cornell University
New York, New York, United States, 10021
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech, Inc.
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Study Director: Nancy Whiting, PharmD Seattle Genetics, Inc.

Additional Information:
Publications of Results:
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Responsible Party: Nancy Whiting, PharmD, Seattle Genetics, Inc. Identifier: NCT00079716     History of Changes
Other Study ID Numbers: SG040-0001
First Posted: March 16, 2004    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
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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
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents