Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00079716
First received: March 11, 2004
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: SGN-40 (anti-huCD40 mAb)
Phase 1

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Adverse events and lab abnormalities. [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: March 2004
Study Completion Date: November 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079716

Locations
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
Investigators
Study Director: Nancy Whiting, PharmD Seattle Genetics, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Nancy Whiting, PharmD, Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00079716     History of Changes
Other Study ID Numbers: SG040-0001
Study First Received: March 11, 2004
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD40
Antibody, Monoclonal
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

ClinicalTrials.gov processed this record on September 16, 2014