Preemptive Strike With Bortezomib in Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

— 2007-77  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00657553
• Other study ID #: 100241
• Status: Terminated
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: October 17, 2017
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2017
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Southwest Oncology Group (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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2	The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates.; Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication.	three years