CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
dexamethasone +1 moredrug
Likely dose
Lenalidomide 15 mg/day for 21 days with 7 days rest (28-day cycle), with or without dexamethasone 20 mg daily (10 mg BID) on days 1-4, 9-12, and 17-20 of every other 28-day cycleAI-extracted
Key inclusion· 4
  • ✓Age 18 and older
  • ✓Histologically confirmed primary systemic (AL) amyloidosis with tissue deposits or positive fat aspirate
  • ✓Serum or urine monoclonal protein by immunofixation electrophoresis OR bone marrow plasmacytosis with monoclonal staining
  • ✓SWOG performance status 0-2
Key exclusion· 8
  • ✕Secondary or familial amyloidosis
  • ✕Multiple myeloma (≥30% plasma cells in bone marrow biopsy OR lytic bone lesions)
  • ✕Prior CC-5013 (lenalidomide) treatment
  • ✕Requires dialysis

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

Search/NCT00091260
NCT00091260Phase 2Completed
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A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis

Vaishali Sanchorawala·interventional·Posted Sep 9, 2004·Updated Feb 20, 2017

In Brief

A Phase 2 clinical trial evaluating dexamethasone and lenalidomide for Multiple Myeloma. Completed, enrolled 82 participants across 1 site.

Detailed Summary

RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis. PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2004
Enrollment StartJan 1, 2004
Primary CompletionJul 1, 2012
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 21.8 years ago

Interventions

dexamethasonedrug

dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

lenalidomidedrug

15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone