CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Vorinostat +2 moredrug
Likely dose
Vorinostat 300 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/NCT00642954
NCT00642954Phase 1Completed
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A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Merck Sharp & Dohme LLC·interventional·Posted Mar 25, 2008·Updated Nov 18, 2020

In Brief

A Phase 1 clinical trial evaluating Vorinostat, Lenalidomide, and 1 other intervention for Relapsed or Refractory Multiple Myeloma. Completed, enrolled 31 participants.

Detailed Summary

The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) as estimated by the incidence of dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D) as estimated by the incidence of drug-related adverse events (AEs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed or Refractory Multiple Myeloma
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 25, 2008
Enrollment StartFeb 13, 2008
Primary CompletionSep 3, 2012
Study CompletionAug 20, 2013
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.3 years ago

Interventions

Vorinostatdrug

Vorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.

Lenalidomidedrug

Lenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.

Dexamethasonedrug

Dexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.