A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

• Status: Terminated
• Trial end date: 2006-02-14
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are:

• To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;

• To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.

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

Details

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

Criteria

Inclusion Criteria:

• Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)

• Adequate bone marrow reserve

• Adequate hepatic and renal function

• Ability to swallow capsules

• 3 weeks or more from prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

• Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment

• Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism

• Patients with other active/uncontrolled clinically significant illnesses

• Pregnant or nursing female patients