Trial Information
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2005_013
NCT ID:
NCT00109109
Start Date:
December 2003
Completion Date:
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell