Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Bortezomib; Vorinostat

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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