CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Pomalidomide +2 moredrug
Likely dose
Pomalidomide 4 mgfrom 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/NCT01432600
NCT01432600Phase 2Completed
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Evaluation of Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide in Patients With Relapsed and Refractory Myeloma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Sep 13, 2011·Updated May 23, 2017

In Brief

A Phase 2 clinical trial evaluating Pomalidomide, Dexamethasone, and 1 other intervention for Myeloma. Completed, enrolled 80 participants across 3 sites.

Detailed Summary

The main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloma
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2011
Enrollment StartNov 1, 2011
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.8 years ago

Interventions

Pomalidomidedrug

Pomalidomide at 4 mg by mouth (PO) as outlined in the treatment arms.

Dexamethasonedrug

Dexamethasone at 40 mg (20 mg) PO as outlined in the treatment arms.

Cyclophosphamidedrug

The dose escalation uses a standard "3x3" design: Ex: If none of the first 3 participants have a DLT, enter 3 participants at the next higher dose level. Once the maximum tolerated dose (MTD) of oral weekly cyclophosphamide in combination with pomalidomide and dexamethasone was determined, investigators proceeded with the second phase of the trial, a randomized phase II study comparing pomalidomide and dexamethasone with pomalidomide, dexamethasone and oral weekly cyclophosphamide delivered at the MTD determined in the phase I study.