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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
Not Enrolling
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

Exclusion Criteria:

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

- 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:


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:


Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

October 2008

Related Keywords:

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



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