Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
A Multicenter, Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
1 other identifier
interventional
222
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Jul 2003
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 21, 2003
CompletedFirst Posted
Study publicly available on registry
July 23, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedNovember 12, 2019
November 1, 2019
3.3 years
July 21, 2003
November 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myeloma response
randomization to progression
Secondary Outcomes (5)
Time to tumor progression
randomization to progression
Duration of response
randomization to progression
Survival (1-year and overall survival)
1 year and ongoing
Time to first skeletal-related event (SRE) (clinical need for radiation or surgery to bone)
randomization to progression
Safety (type, frequency, severity, and relationship of adverse events to study drug)
ongoing
Study Arms (1)
1
EXPERIMENTALCC-5013 - oral - 30mg daily on days 1-21 every 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (26)
Palo Verde Hematology Oncology
Glendale, Arizona, 85304, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
Providence St. Joseph Medical Center/Cancer Center
Burbank, California, 91505, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750, United States
Institute for Myeloma and Bone
Los Angeles, California, 90067, United States
Cancer Care Associates
Redondo Beach, California, 90277, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
Atlanta Cancer Care-Roswell
Roswell, Georgia, 30076, United States
Northwestern University Med Ctr
Chicago, Illinois, 60611-2927, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201-1595, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20717, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
SUNY Health Science Center at Brooklyn
Brooklyn, New York, 11203, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
Carolina Hematology-Oncology Associates
Charlotte, North Carolina, 28203, United States
Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35
Cleveland, Ohio, 44195, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
Related Publications (1)
Richardson P, Jagannath S, Hussein M, Berenson J, Singhal S, Irwin D, Williams SF, Bensinger W, Badros AZ, Vescio R, Kenvin L, Yu Z, Olesnyckyj M, Zeldis J, Knight R, Anderson KC. Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma. Blood. 2009 Jul 23;114(4):772-8. doi: 10.1182/blood-2008-12-196238. Epub 2009 May 26.
PMID: 19471019BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Knight, MD
Celgene
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2003
First Posted
July 23, 2003
Study Start
July 1, 2003
Primary Completion
October 1, 2006
Study Completion
March 1, 2007
Last Updated
November 12, 2019
Record last verified: 2019-11