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

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ClinicalTrials.gov Identifier: NCT00109109

Recruitment Status : Terminated

First Posted : April 25, 2005

Last Update Posted : April 5, 2017

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Tracking Information

First Submitted Date ^ICMJE

April 22, 2005

First Posted Date ^ICMJE

April 25, 2005

Last Update Posted Date

April 5, 2017

Actual Study Start Date ^ICMJE

December 1, 2003

Actual Primary Completion Date

February 14, 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00109109 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

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

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date

February 14, 2006

Actual Primary Completion Date

February 14, 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

United States

Administrative Information

NCT Number ^ICMJE

NCT00109109

Other Study ID Numbers ^ICMJE

0683-004
2005_013

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck Sharp & Dohme Corp.

PRS Account

Merck Sharp & Dohme Corp.

Verification Date

April 2017

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

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