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

December 17, 2014 updated by: Seagen Inc.

A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Hollywood, California, United States, 90069
        • James R. Berenson M.D., Inc.
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10021
        • Cornell University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • dacetuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events and lab abnormalities.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Nancy Whiting, PharmD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

March 11, 2004

First Submitted That Met QC Criteria

March 15, 2004

First Posted (Estimate)

March 16, 2004

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG040-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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