CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
vorinostat +1 moredrug
Likely dose
Vorinostat capsules daily × 14 days per 21-day cycle; bortezomib injection twice weekly × 2 weeks per 21-day cycle (specific doses not stated)AI-extracted
Key inclusion· 6
  • Adults with refractory or relapsed multiple myeloma
  • ECOG performance status 0–2
  • Adequate bone marrow reserve
  • Adequate hepatic and renal function
Key exclusion· 5
  • Planned bone marrow transplant within 4 weeks of treatment start
  • Prior treatment with other investigational agents with similar anti-tumor mechanism
  • Active/uncontrolled clinically significant illness
  • Pregnant or nursing

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

Search/NCT00111813
NCT00111813Phase 1Completed

Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma

Merck Sharp & Dohme LLC·interventional·Posted May 26, 2005·Updated May 21, 2015

In Brief

A Phase 1 clinical trial evaluating vorinostat and bortezomib for Multiple Myeloma. Completed, enrolled 34 participants.

Detailed Summary

The purposes of this study are: * To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma * To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2005
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2009
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 21.1 years ago

Interventions

vorinostatdrug

Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).

bortezomibdrug

Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.