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

Phase 1TerminatedNCT00109109

Merck Sharp & Dohme LLC60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.