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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00424047
First received: January 17, 2007
Last updated: April 22, 2014
Last verified: April 2014

January 17, 2007
April 22, 2014
January 2003
November 2005   (final data collection date for primary outcome measure)
Time to tumor progression (TTP) [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
Time from randomization to the first documentation of progressive disease based on the Myeloma response determination criteria developed by Bladé et al 1998
Not Provided
Complete list of historical versions of study NCT00424047 on ClinicalTrials.gov Archive Site
  • Number of patients who survived [ Time Frame: Up to 23 months ] [ Designated as safety issue: Yes ]
    Time from randomization to death from any cause
  • Number of participants with adverse events [ Time Frame: Up to 23 months ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events
  • Myeloma response rate [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
    Myeloma response determination criteria developed by Bladé et al 1998
  • Time to first symptomatic skeletal-related event (SRE) (clinical need for radiation or surgery to bone) [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
    Time for randomization to the date of the first occurred of a symptomatic SRE (clinical need for radiotherapy or surgery to bone)
  • Time to first worsening on the Eastern Cooperative Oncology Group (ECOG) performance scale [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
    Time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization
Not Provided
Not Provided
Not Provided
 
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: CC-5013 plus dexamethasone
    25 mg daily for 21 days every 28 days.
    Other Names:
    • Revlimid
    • lenalidomide
  • Drug: Dexamethasone plus Placebo
    Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
    Other Names:
    • Dexamethasone
    • Placebo
  • Experimental: CC-5013 plus dexamethasone
    Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle.
    Intervention: Drug: CC-5013 plus dexamethasone
  • Experimental: Dexamethasone plus placebo
    Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
    Intervention: Drug: Dexamethasone plus Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
351
November 2013
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
  • Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2
  • Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug

Exclusion Criteria:

  • Prior development of disease progression during high-dose dexamethasone containing therapy
  • Pregnant or lactating females
  • The development of a desquamating rash while taking thalidomide
  • Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
  • Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3
  • Laboratory abnormalities: Platelet count < 75,000/mm3
  • Laboratory abnormalities: Serum creatinine > 2.5 mg/dL
  • Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal
  • Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL
  • Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Italy,   Ireland,   Australia,   United Kingdom,   France,   Switzerland,   Ukraine,   Belgium,   Spain,   Israel,   Poland,   Germany,   Sweden,   Austria
 
NCT00424047
CC-5013-MM-010
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Robert Knight, MD Celgene Corporation
Celgene Corporation
April 2014

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