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CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00056160
Recruitment Status : Completed
First Posted : March 7, 2003
Results First Posted : March 3, 2010
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE March 6, 2003
First Posted Date  ICMJE March 7, 2003
Results First Submitted Date  ICMJE December 24, 2009
Results First Posted Date  ICMJE March 3, 2010
Last Update Posted Date October 19, 2017
Actual Study Start Date  ICMJE January 1, 2003
Actual Primary Completion Date November 1, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
Time to Tumor Progression (TTP) [ Time Frame: 60 weeks (median Time To Progression of CC-5013/Dex treatment group) ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00056160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
  • Overall Survival [ Time Frame: 170 weeks (median overall survival of CC-5013/Dex treatment group) ]
    Overall survival was calculated as the time from randomization to death from any cause.
  • Myeloma Response [ Time Frame: Up to Unblinding (07 Jun 2005) ]
    The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
  • Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.) [ Time Frame: 30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group) ]
    The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Official Title  ICMJE 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
Brief Summary Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: CC-5013
    Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide 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.
    Other Names:
    • lenalidomide
    • Revlimid
  • Drug: Dexamethasone
    Subjects in the CC-5013/Dex and Placebo/Dex 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.
    Other Name: Decadron
Study Arms  ICMJE
  • Experimental: CC-5013/Dex
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    Interventions:
    • Drug: CC-5013
    • Drug: Dexamethasone
  • Experimental: Placebo/Dex
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    Intervention: Drug: Dexamethasone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2010)
353
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
302
Actual Study Completion Date  ICMJE October 1, 2008
Actual Primary Completion Date November 1, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00056160
Other Study ID Numbers  ICMJE CC-5013-MM-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Knight, MD Celgene Corporation
PRS Account Celgene
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP