Study of Vorinostat (MK0683, SAHA) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00111813

Purpose

The purposes of this study are:

To determine the maximum tolerated dose (MTD) for the combination of oral SAHA and bortezomib in patients with advanced multiple myeloma.
To assess the safety and tolerability of this regimen and to document the patient's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Suberoylanilide Hydroxamic Acid (SAHA) Drug: Bortezomib	Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Suberoylanilide hydroxamic acid Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma.

Further study details as provided by Merck:

Primary Outcome Measures:

Maximum tolerated dose (MTD) after 14 consecutive day treatment for 21 day cycles as measured by unacceptable toxicity. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability as measured by disease progression or unacceptable toxicity during each treatment cycle. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	33
Study Start Date:	October 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 vorinostat; bortezomib	Drug: Suberoylanilide Hydroxamic Acid (SAHA) Dose escalation study starting with vorinostat 200 mg b.i.d. capsules and rising up to vorinostat 300 mg b.i.d. capsules, twice daily. Treatment in 21 day cycles. Up to 24 weeks of treatment. Drug: Bortezomib Dose escalation with bortezomib 0.7 mg/m2 injection rising up to 1.3 mg/m2 injection, twice weekly. Treatment in 21 day cycles. Up to 24 weeks of treatment.

Arms

Assigned Interventions

1

vorinostat; bortezomib

Drug: Suberoylanilide Hydroxamic Acid (SAHA)

Dose escalation study starting with vorinostat 200 mg b.i.d. capsules and rising up to vorinostat 300 mg b.i.d. capsules, twice daily. Treatment in 21 day cycles. Up to 24 weeks of treatment.

Drug: Bortezomib

Dose escalation with bortezomib 0.7 mg/m2 injection rising up to 1.3 mg/m2 injection, twice weekly. Treatment in 21 day cycles. Up to 24 weeks of treatment.

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
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine patient's ability to perform daily activities)
Adequate bone marrow reserve
Adequate hepatic and renal function
Ability to swallow capsules
3 weeks or more since prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

Patients who plan to have a 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 illness
Pregnant or nursing female patients
Patients who received bortezomib within 3 months of start of this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111813

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_018, MK0683-015
Study First Received:	May 25, 2005
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00111813
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vorinostat
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Protease Inhibitors

Neoplasms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009