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A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma


This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of
the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse
high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple
myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups:
Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days
1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle;
Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each
28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once
daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of
therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once
daily on Days 1 to 4 for the remaining cycles.


Inclusion Criteria:



- Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.

- No more than 3 previous anti-myeloma regimens

- No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg)
within 6 months of study randomization.

- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection
sample).

Exclusion Criteria:

- Prior development of disease progression during high-dose dexamethasone containing
therapy.

- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed

- Laboratory abnormalities: Platelet count less than 75,000/mm cubed

- Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL

- Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate
transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine
transaminase [ALT])greater than 3.0 x upper limit of normal

- Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL

- Prior history of malignancies other than multiple myeloma unless the subject has been
free of the disease for greater than or equal to 5 years.

- Known hypersensitivity to thalidomide or dexamethasone.

- Development of a desquamating rash while taking thalidomide.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Tumor Progression (TTP)

Outcome Description:

Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.

Outcome Time Frame:

60 weeks (median Time To Progression of CC-5013/Dex treatment group)

Safety Issue:

No

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MM-009

NCT ID:

NCT00056160

Start Date:

January 2003

Completion Date:

October 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Refractory and Relapsed
  • Revlimid
  • CC5013
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
UCLA School of MedicineLos Angeles, California  900121973
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Loyola University Medical CenterMaywood, Illinois  60153
Hackensack University Medical CenterHackensack, New Jersey  07601
City of Hope National Medical CenterLos Angeles, California  91010
Medical College of GeorgiaAugusta, Georgia  30912
University of PittsburghPittsburgh, Pennsylvania  15261
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
Duke University Medical CenterDurham, North Carolina  27710
SUNY Upstate Medical UniversitySyracuse, New York  13210
University of FloridaGainesville, Florida  32610-0277
Oncology Hematology ConsultantsSarasota, Florida  34239
Emory UniversityAtlanta, Georgia  30322
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Ohio State UniversityColumbus, Ohio  43210
H Lee Moffitt Cancer CenterTampa, Florida  33612
Sarah Cannon Cancer CenterNashville, Tennessee  37203
University of MiamiMiami, Florida  33136
New York Presbyterian HospitalNew York, New York  10021
Yale University School Of MedicineNew Haven, Connecticut  06520
Clinical Research Consultants, Inc.Hoover, Alabama  35216
UCSF CaliforniaSan Francisco, California  94143
Stanford University Medical Center, Division of HematologyStanford, California  94305-5112
Mayo Clinic- JacksonvilleJacksonville, Florida  32224
Northwestern University Med CtrChicago, Illinois  60611-2927
Rush Cancer Institute Section of HematologyChicago, Illinois  60612-3824
Indiana Cancer Research InstituteIndianapolis, Indiana  46202-5254
University of Iowa Hospital ClinicIowa City, Iowa  52242
Ocshner Clinical FoundationNew Orleans, Louisiana  70121
Johns Hopkins Medicine Department of OncologyBaltimore, Maryland  21231
Karmanos Cancer InstituteDetroit, Michigan  48201
Washington University School of Medicine- Sherman Cancer CenterSt. Louis, Missouri  63110
MBCCOP Our Lady of Mercy Cancer Center New York Medical CollegeBronx, New York  10466
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Cleveland Clinic Myeloma ProgramCleveland, Ohio  44195
Kaiser Permanente Northwest Region Center for Health ResearchPortland, Oregon  97227
Charleston Hematology/Oncology P.A.Charleston, South Carolina  29403
Medical University of SCCharleston, South Carolina  29425
South Carolina Oncology GroupWest Columbia, South Carolina  29169
Froedtert Hospital/BMT Medical College of WisconsinMilwaukee, Wisconsin  53226-3522