Preemptive Strike With Bortezomib in Multiple Myeloma Patients (2007-77)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657553
Recruitment Status : Terminated (Due to poor accrual)
First Posted : April 14, 2008
Results First Posted : July 12, 2011
Last Update Posted : November 20, 2017
Information provided by (Responsible Party):
University of Arkansas

April 9, 2008
April 14, 2008
April 14, 2011
July 12, 2011
November 20, 2017
February 2008
January 2009   (Final data collection date for primary outcome measure)
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 ]

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.

The amount of patients on Bortezomib that have maintained event-free survival will be compared to the patients on observation. [ Time Frame: three years ]
Complete list of historical versions of study NCT00657553 on Archive Site
Not Provided
  • To determine if there is any increase in the amount of positive response when given Bortezomib alone. [ Time Frame: Three Years ]
  • To determine if Bortezomib will cause the reduction in MRI-defined focal lesions. [ Time Frame: Three years ]
  • To evaluate whether Bortezomib will induce bone formation. [ Time Frame: Three Years ]
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Preemptive Strike With Bortezomib in Multiple Myeloma Patients
Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)
To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.
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.
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
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
Other Name: Velcade
  • 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
    Intervention: Drug: Bortezomib
  • No Intervention: Observation Arm (watchful waiting)
    monitor myeloma parameters every 3-6 months
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Bart Barlogie, MD, PhD UAMS
University of Arkansas
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP