Status:
COMPLETED
Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 sa...
Eligibility Criteria
Inclusion
- Adults with refractory or relapsed multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
- Adequate bone marrow reserve
- Adequate hepatic and renal function
- Ability to swallow capsules
- 3 weeks or more since prior chemotherapy and have recovered from prior toxicities
Exclusion
- Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
- Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
- Participants with other active/uncontrolled clinically significant illness
- Pregnant or nursing female participants
- Participants who received bortezomib within 3 months of start of this trial
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00111813
Start Date
September 1 2005
End Date
May 1 2011
Last Update
May 21 2015
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