Preemptive Strike With Bortezomib in Multiple Myeloma Patients (2007-77)
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility 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 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
Sites / Locations
- University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Bortezomib/Treatment Arm
Observation Arm (watchful waiting)
Arm Description
Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months
monitor myeloma parameters every 3-6 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00657553
Brief Title
Preemptive Strike With Bortezomib in Multiple Myeloma Patients
Acronym
2007-77
Official Title
Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to poor accrual
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib/Treatment Arm
Arm Type
Active Comparator
Arm Description
Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months
Arm Title
Observation Arm (watchful waiting)
Arm Type
No Intervention
Arm Description
monitor myeloma parameters every 3-6 months
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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
Primary Outcome Measure Information:
Title
Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2
Description
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.
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Barlogie, MD, PhD
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
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Preemptive Strike With Bortezomib in Multiple Myeloma Patients
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