At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 353 enrolled

Drug / intervention

CC-5013 +1 moredrug

Likely dose

Lenalidomide 25 mg orally once daily on Days 1–21 of each 28-day cycle, plus dexamethasone 40 mg orally once daily on Days 1–4, 9–12, and 17–20 (Cycles 1–4); 40 mg on Days 1–4, 9–12, and 17–20 beginning Cycle 5AI-extracted

Key inclusion· 4

✓Durie-Salmon stage II or III multiple myeloma (prior or current diagnosis)
✓No more than 3 previous anti-myeloma regimens
✓No high-dose dexamethasone (>200 mg monthly) within 6 months of randomization
✓Measurable serum or urine myeloma paraprotein

Key exclusion· 9

✕Prior disease progression during high-dose dexamethasone-containing therapy
✕Absolute neutrophil count <1,000 cells/mm³
✕Platelet count <75,000/mm³
✕Serum creatinine >2.5 mg/dL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00056160

NCT00056160Phase 3Completed

Compare CT.gov

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

Celgene·interventional·Posted Mar 7, 2003·Updated Oct 19, 2017

In Brief

A Phase 3 clinical trial evaluating CC-5013 and Dexamethasone for Multiple Myeloma. Completed, enrolled 353 participants across 49 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMultiple Myeloma

CountriesCanada, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2003

First PostedMar 2003

Primary CompletionNov 2005

Study CompletionOct 2008

TodayJul 2026

First PostedMar 7, 2003

Enrollment StartJan 1, 2003

Primary CompletionNov 1, 2005

Study CompletionOct 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 23.3 years ago

Interventions

CC-5013drug

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.

Dexamethasonedrug

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.