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

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ClinicalTrials.gov Identifier: NCT00079716
Recruitment Status : Completed
First Posted : March 16, 2004
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE March 11, 2004
First Posted Date  ICMJE March 16, 2004
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE March 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Adverse events and lab abnormalities.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00079716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
Official Title  ICMJE A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma
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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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
Study Arms Experimental: 1
Intervention: Drug: SGN-40 (anti-huCD40 mAb)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2008)
44
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
21
Actual Study Completion Date November 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00079716
Other Study ID Numbers  ICMJE SG040-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nancy Whiting, PharmD, Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Study Director: Nancy Whiting, PharmD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP