Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN)

Plain-language summary

This study evaluates Vorinostat (MK-0683) or placebo, combined with Bortezomib, in patients with multiple myeloma (a bone marrow cancer) that progressed after prior treatment. It included patients with confirmed myeloma who had failed 1-3 prior regimens. It was a Phase 3 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Merck Sharp & Dohme LLC

Intervention

Vorinostat, bortezomib, placebo to vorinostat

Start date

12/1/2008

Estimated completion

6/30/2015

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion criteria

* Participant has an established diagnosis of multiple myeloma based on the myeloma diagnostic criteria.
* Participant has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen.
* Participant must have adequate organ function.

Exclusion criteria:

* Participant has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation within 4 weeks of the initiation of study therapy.
* Participant has known hypersensitivity to any components of bortezomib or vorinostat.
* Participant has active Hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive.
* Participant has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors.