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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00109109
First received: April 22, 2005
Last updated: May 15, 2014
Last verified: May 2014

April 22, 2005
May 15, 2014
December 2003
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  • 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.
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Complete list of historical versions of study NCT00109109 on ClinicalTrials.gov Archive Site
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.
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A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00109109
0683-004, 2005_013
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP