Brief 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.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline

Completed

Started Sep 2005

Typical duration for phase_1 multiple-myeloma

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

First Submitted

Initial submission to the registry

May 25, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2005

Completed

3 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

April 6, 2011

Completed

25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed

Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

4.3 years

First QC Date

May 25, 2005

Results QC Date

March 10, 2011

Last Update Submit

May 5, 2015

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

Mean Duration of Treatment With Vorinostat
Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as: * \>25% increase in the level of serum monoclonal paraprotein. * 25% increase in 24-hour urinary light chain excretion. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy. * Development of new bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia. Intolerable toxicity was based on the clinical judgment of the investigator.
Day 1 to an event causing discontinuation from the study, assessed up to 29 months

Secondary Outcomes (4)

Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
Clinical AE Summary
Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
Laboratory AE Summary
Day 1 up to disease progression, toxicity, or death, assessed up to 29 months

Study Arms (6)

vorinostat 200 mg + bortezomib 0.7 mg/m^2

EXPERIMENTAL

Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.