Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

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

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