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Phase II Multicenter Open Label Study of Single-Agent REVIMID
08.09.04
THIS TRIAL IS CLOSED.

A multicenter, non-randomized, open label, uncontrolled, single group assignment, safety/efficacy study of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma
This study, sponsored by Celgene Corporation is currently recruiting patients.

Purpose

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.

Ages Eligible for Study: 18 Years - N/A,

Genders Eligible for Study: Both

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 .
  • 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

Expected Total Enrollment: 200

A list of sites currently enrolling patients in this trial appears below:

Location and Contact Information - United States
Arizona Palo Verde Hematology Oncology
Glendale, AZ
Study contact:
Deborah Jackson, RN
Phone: 602-978-6255

Joe Volk, MD
Principal Investigator

Mayo Clinic
Scottsdale, AZ
Study contact:
Johanna Young, RN
Phone: 480-301-4473

Craig Reeder, MD
Principal Investigator

California Alta Bates Cancer Center
Berkeley, CA
Study contact:
Beth Davis
Phone: 510-204-3428

David Irwin, MD
Principal Investigator

Providence St. Joseph Medical Center
Burbank, CA
Study contact:
Evelyn Dizon
Phone: 818-847-3218

Raul Mena, MD
Principal Investigator

City of Hope National Medical Center
Duarte, CA
Contact:
Nicole Yamamoto
626-359-8111 x65281

George Somlo, MD
Principal Investigator

Cancer Care Associates
Redondo Beach, CA
Study contact:
Mary Byrne
Phone: 310-750-3300

Syed Jilani, MD
Principal Investigator

Florida Mayo Clinic
Jacksonville, FL
Study contact:
Jenna Rogers
Phone: 904-953-6136

Roy Vivek, MD
Principal Investigator

Georgia Atlanta Cancer Center
Atlanta, GA
Study contact:
Deborah Muse
Phone: 404-851-2359

Ronald Steis, MD
Principal Investigator

Northwest Georgia Oncology Centers
Marietta, GA
Study contact:
Cathy Barham
Phone: 678-594-4319

Robert Hermann, MD
Principal Investigator

Illinois Midwest Cancer Research Group
Skokie, IL
Study contact:
Julianne Rodriguez
Phone: 312-664-5400

Stephanie Williams, MD
Principal Investigator

Maryland University of Maryland Medical Center
Baltimore, MD
Study contacts:
Bashi Ratterree or Sabrina Natt
Phone: 410-328-8199

Ashraf Badros, MD
Principal Investigator

Center for Cancer and Blood Disorders
Bethesda, MD
Study contact:
Jason Denner
Phone: 301-571-0019

Ralph V. Boccia, MD
Principal Investigator

Massachusetts Dana-Farber Cancer Institute
Boston, MA
Study contact:
Kathleen Kelly
Phone: 617-632-2104

Paul Richardson, MD
Principal Investigator

Massachusetts General Hospital
Boston, MA
Study contact:
Barbara Stoklas
Phone: 617-724-5251

David Kuter, MD
Principal Investigator

University of Massachusetts
Worcester, MA
Study contact:
Judie O'Donnell
Phone: 508-856-1385

Ann Traynor, MD
Principal Investigator

Minnesota Mayo Clinic
Rochester, MN
Study contact:
Tami Simmons
Phone: 507-266-0733

Steven Zeldenrust, MD
Principal Investigator

Nevada Nevada Cancer Center
Las Vegas, NV
Study contact:
Andrea Armfield
Phone: 702-735-7154 x109

Ann Weirmen, MD
Principal Investigator

New York St. Vincent's Comprehensive Cancer Center
New York, NY
Study contact:
Stephanie Stoss
Phone: 212-604-6027

Sundar Jagannath, MD
Principal Investigator

North Carolina Carolinas Hematology Oncology Associates
Charlotte, NC
Study contact:
Sandra Oliphant
Phone: 704-355-8261

Steven Limentani, MD
Principal Investigator

Ohio Cleveland Clinic Myeloma Program
Cleveland, OH
Study contact:
Janice Reed
Phone: 216-444-0589

Mohammad A. Hussein, MD
Principal Investigator

Pennsylvania Western Pennsylvania Cancer Institute
Pittsburgh, PA
Study contact:
Kris Khairallah
Phone: 412-578-1034

Richard Shadduck, MD
Principal Investigator

Washington Fred Hutchinson Cancer Research Center
Seattle, WA
Study contact:
Kathy Lilleby, RN
Phone: 206-667-5836

William Bensinger, MD
Principal Investigator

Swedish Cancer Institute
Seattle, WA
Study contact:
Christine Reed
Phone: 206-386-3650

Henry Kaplan, MD
Principal Investigator


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