Status:
COMPLETED
Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study of the efficacy and safety of bortezomib administered in combination with vorinostat in patients with relapsed or refractory multiple myeloma. Histone deacetylases (HDAC) facilitate gene transcr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2015
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT00773747
Start Date
December 1 2008
End Date
June 30 2015
Last Update
April 30 2021
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