CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
azacitidine +8 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/NCT01155583
NCT01155583Phase 2Completed

A Phase I/II Trial Of Very Low to Low-Doses of Continuous Azacitidine in Combination With Standard Doses of Lenalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Case Comprehensive Cancer Center·interventional·Posted Jul 2, 2010·Updated Nov 16, 2020

In Brief

A Phase 2 clinical trial evaluating azacitidine, lenalidomide, and 7 other interventions for Refractory Multiple Myeloma. Completed, enrolled 45 participants across 2 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine and dexamethasone, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving azacitidine together with lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when given together with lenalidomide and low-dose dexamethasone in treating patients with relapsed or refractory multiple myeloma.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2010
Enrollment StartJun 1, 2010
Primary CompletionMay 28, 2016
Study CompletionNov 6, 2018
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 16 years ago

Interventions

azacitidinedrug

Given by subcutaneous injection (SC)

lenalidomidedrug

Given orally

dexamethasonedrug

Given orally

DNA methylation analysisother

Correlative studies

gene expression analysisother

Correlative studies

bone marrow aspirationother

Correlative studies

immunohistochemistry staining methodother

Correlative studies

reverse transcriptase-polymerase chain reactionother

Correlative studies

flow cytometryother

Correlative studies