Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma

October 7, 2014 updated by: Seagen Inc.

A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)

This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 abnormal.

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.

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
2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.
Other Names:
  • dacetuzumab
Drug: lenalidomide
Up to 25 mg daily of a 21-day cycle.
Other Names:
  • Revlimid
Drug: dexamethasone
40 mg administered weekly.
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events and lab abnormalities.
Time Frame: Within 3 weeks of final infusion of SGN-40
Within 3 weeks of final infusion of SGN-40

Secondary Outcome Measures

Outcome Measure
Time Frame
Best clinical response, progression-free survival, and overall survival.
Time Frame: Study duration
Study duration
PK profile.
Time Frame: Within 3 weeks of final infusion of SGN-40
Within 3 weeks of final infusion of SGN-40
Anti-drug antibody immune responses.
Time Frame: Within 3 weeks of final infusion of SGN-40
Within 3 weeks of final infusion of SGN-40

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.

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

August 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (Estimate)

September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG040-0006

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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