Pre-Emptive Strike With Bortezomib in Multiple Myeloma Patients - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00657553

Purpose

The purpose of this study is to evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Bortezomib	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Active Control, Efficacy Study, Open Label, Randomized, Single Group Assignment, Treatment
Official Title:	Pre-Emptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-Free on Total Therapy 2 (UARK 98-026)

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

The amount of patients on Bortezomib that have maintained event-free survival will be compared to the patients on observation. [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if there is any increase in the amount of positive response when given Bortezomib alone. [ Time Frame: Three Years ] [ Designated as safety issue: No ]
To determine if Bortezomib will cause the reduction in MRI-defined focal lesions. [ Time Frame: Three years ] [ Designated as safety issue: No ]
To evaluate whether Bortezomib will induce bone formation. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Arm: Active Comparator Bortezomib will be administered every in doses over the course of three years.	Drug: Bortezomib Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks
Observation Arm: No Intervention Patients will simply be observed for progress over the course of three years.

Detailed Description:

Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. Bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and currently event-free at the time of the evaluation.
Performance status of 0-2 based of SWOG criteria
Previously documented platelet count > 75,000/ul within a 35 days prior to enrollment
Previously documented peripheral absolute neutrophil count >1,000/ul within 35 days prior to enrollment.
Adequate renal function
Signed informed consent
Female subject is post-menopausal or willing to use acceptable birth control
Male subjects agree to use acceptable method of contraceptive

Exclusion Criteria:

Hypersensitivity to Bortezomib, boron, or mannitol
Female subject is pregnant or breastfeeding
Experienced myocardial infraction within 6 months prior to enrollment
Received other investigational new drugs within 14 days before enrollment
Received any anti-myeloma therapy within 14 days
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Diagnosed or treated for another malignancy within 3 years of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657553

Contacts

Contact: Bart Barlogie, MD, PhD

501-526-2873

bbarlogie@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy	Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: Bart Barlogie, MD, PhD
Sub-Investigator: Frits van Rhee, MD, PhD
Sub-Investigator: Elias Anaissie, MD
Sub-Investigator: Monica Grazziutti, MD
Sub-Investigator: Mehmet Hakan Kocoglu, MD
Sub-Investigator: Sarah Waheed, MD
Sub-Investigator: Divaya Bhutani, MD
Sub-Investigator: Syed Abbas Ali, MD
Sub-Investigator: Somashekar G Krishna, MD
Sub-Investigator: Yazan Alsayed, MD
Sub-Investigator: Pooja Motwani, MD
Sub-Investigator: Klaus Hollmig, MD
Sub-Investigator: Mauricio Pineda-Roman, MD
Sub-Investigator: Elias Kiwan, MD

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Bart Barlogie, MD, PhD

UAMS

More Information

No publications provided

Responsible Party:	Myeloma Institute for Research and Therapy ( Bart Barlogie, MD, PhD )
Study ID Numbers:	100241
Study First Received:	April 9, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00657553 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

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

Hemostatic Disorders
Multiple Myeloma
Protease Inhibitors
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Bortezomib
Vascular Diseases
Enzyme Inhibitors
Paraproteinemias

Hemostatic Disorders
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on March 13, 2009