Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma

November 7, 2019 updated by: Celgene

A Multicenter, Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma

For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline.

Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter.

Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

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
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology Oncology
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Burbank, California, United States, 91505
        • Providence St. Joseph Medical Center/Cancer Center
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group, Inc.
      • Los Angeles, California, United States, 90067
        • Institute for Myeloma and Bone
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers
      • Roswell, Georgia, United States, 30076
        • Atlanta Cancer Care-Roswell
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Med Ctr
      • Skokie, Illinois, United States, 60077
        • Midwest Cancer Research Group
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
        • University of Maryland Medical Center
      • Bethesda, Maryland, United States, 20717
        • Center for Cancer and Blood Disorders
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cancer Center
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Health Science Center at Brooklyn
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolina Hematology-Oncology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research 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:

  • Understand and voluntarily sign an informed consent form.
  • Age greater than or equal to 18 years at the time of signing the informed consent form.
  • Must have a diagnosis of multiple myeloma and have relapsed and refractory disease. Such subjects have relapsed after having had at least a partial myeloma paraprotein response (greater or equal to 50% reduction of myeloma paraprotein) to prior therapy and then continued to develop disease progression despite salvage anti-myeloma therapy. Subjects must have documented evidence of disease progression during therapy with the last prior anti-myeloma treatment regimen (must have received at least 2 cycles) prior to study enrollment.Subjects may have been previously treated with thalidomide and/or radiation therapy.
  • Measurable levels of myeloma paraprotein in serum (greater or equal to 0.5 g/dL) or urine (greater or equal to 0.2 g excreted in a 24-hour collection sample).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Appendix II).
  • Able to adhere to the study visit schedule and other protocol requirements
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.

Exclusion Criteria:

  • Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
  • WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • Any of the following laboratory abnormalities:

A) Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L) B) Platelet count <75,000/mm^3 (75 x 10^9/L) C) Serum creatinine >2.5 mg/dL (221 umol/L) D) Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) E) Serum total bilirubin >2.0 mg/dL (34 umol/L)

  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for greater than or equal to 3 years.
  • Prior greater than or equal to grade 3 allergic reaction/hypersensitivity to thalidomide.
  • Prior greater than or equal to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  • Prior use of CC-5013.
  • Use of any standard/experimental anti-myeloma drug therapy within 28 days of the initiation of study drug therapy or use of any experimental non-drug therapy within 56 days of the initiation of study drug therapy

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CC-5013 - oral - 30mg daily on days 1-21 every 28 days
Drug: CC-5013
CC-5013 - oral - 30mg daily on days 1-21 every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myeloma response
Time Frame: randomization to progression
randomization to progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to tumor progression
Time Frame: randomization to progression
randomization to progression
Duration of response
Time Frame: randomization to progression
randomization to progression
Survival (1-year and overall survival)
Time Frame: 1 year and ongoing
1 year and ongoing
Time to first skeletal-related event (SRE) (clinical need for radiation or surgery to bone)
Time Frame: randomization to progression
randomization to progression
Safety (type, frequency, severity, and relationship of adverse events to study drug)
Time Frame: ongoing
ongoing

Collaborators and Investigators

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

Sponsor

Celgene

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

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 (Actual)

July 1, 2003

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 21, 2003

First Submitted That Met QC Criteria

July 22, 2003

First Posted (Estimate)

July 23, 2003

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MM-014

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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