CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 452 enrolled
Drug / intervention
Dexamethasone +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00098475
NCT00098475Phase 3Active

A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders

National Cancer Institute (NCI)·interventional·Posted Dec 8, 2004·Updated May 12, 2026

In Brief

A Phase 3 clinical trial evaluating Dexamethasone, Laboratory Biomarker Analysis, and 2 other interventions for DS Stage I Multiple Myeloma and 2 related conditions. Active but no longer recruiting, targeting 452 participants across 138 sites.

Detailed Summary

This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3Active
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 8, 2004
Enrollment StartNov 3, 2004
Primary CompletionNov 30, 2008
Study CompletionOct 23, 2026
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 21.6 years ago

Interventions

Dexamethasonedrug

Given PO

Laboratory Biomarker Analysisother

Optional correlative studies

Lenalidomidedrug

Given PO

Thalidomidedrug

Given PO