Preemptive Strike With Bortezomib in Multiple Myeloma Patients (2007-77)
To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)|
- Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2 [ Time Frame: three years ] [ Designated as safety issue: No ]
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.
- Response Rate of Participants Given Bortezomib Alone [ Time Frame: Three Years ] [ Designated as safety issue: No ]Fraction of participants on the PIB arm who convert from PR (Partial Response) to VGPR (very good Partial Response) or CR (Complete Response) and those in VGPR to CR
|Study Start Date:||February 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Bortezomib/Treatment Arm
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
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
Other Name: Velcade
No Intervention: Observation Arm (watchful waiting)
monitor myeloma parameters every 3-6 months
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.
|United States, Arkansas|
|University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Bart Barlogie, MD, PhD||UAMS|