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

Phase 1

Terminated

• Conditions: Multiple Myeloma

• Registration Number: NCT00109109
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-01
• Study First Submitted: 2005-04-22
• Study First Submitted QC: 2005-04-22
• Study First Posted: 2005-04-25
• Primary Completion: 2006-02-14
• Study Completion: 2006-02-14
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.

Secondary Outcome Measures

Name	Time	Method
1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.