CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,913 enrolled
Drug / intervention
lenalidomide +1 moredrug
Likely dose
Lenalidomide 5-25 mg orally once daily for 21 days every 28 days, with or without dexamethasone 20-40 mg orally once dailyAI-extracted
Key inclusion· 4
  • ✓Diagnosed with multiple myeloma that is progressing after at least 2 cycles of prior anti-myeloma treatment or that has relapsed with progressive disease after treatment
  • ✓Measurable myeloma paraprotein: serum ≥0.5 g/dL or urine ≥0.2 g in 24-hour collection
  • ✓ECOG performance status 0, 1, or 2
  • ✓Age ≥18 years
Key exclusion· 10
  • ✕Pregnant or lactating females
  • ✕Known hypersensitivity to thalidomide or dexamethasone
  • ✕Prior history of uncontrollable side effects to dexamethasone therapy
  • ✕Development of desquamating rash while taking thalidomide

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

Search/NCT00179647
NCT00179647Phase 3Completed
CompareCT.gov

A Multicenter, Single-Arm, Open-Label, Expanded Access Program for Lenalidomide With or Without Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Celgene Corporation·interventional·Posted Sep 16, 2005·Updated Mar 16, 2010

In Brief

A Phase 3 clinical trial evaluating lenalidomide and dexamethasone for Multiple Myeloma. Completed, enrolled 1,913 participants across 69 sites in 2 countries.

Detailed Summary

Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for the indication of multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesCanada, United States
CollaboratorsPrologue Research International

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

lenalidomidedrug

Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone

dexamethasonedrug

Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens