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Preemptive Strike With Bortezomib in Multiple Myeloma Patients

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Bortezomib (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: University of Arkansas

Official(s) and/or principal investigator(s):
Bart Barlogie, MD, PhD, Principal Investigator, Affiliation: UAMS

Summary

To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

Clinical Details

Official title: Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2

Secondary outcome: Response Rate of Participants Given Bortezomib Alone

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy, Little Rock, Arkansas 72205, United States
Additional Information

Starting date: February 2008
Last updated: June 13, 2011

Page last updated: August 23, 2015

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