A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00109109

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	60
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109109

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00109109 History of Changes
Other Study ID Numbers:	2005_013
Study First Received:	April 22, 2005
Last Updated:	January 26, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012