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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months

Study type: Interventional

Funder types: Industry

Identifiers

NCT00109109

0683-004

2005_013

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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