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

This study has been terminated.
(Due to poor accrual)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00657553
First received: April 9, 2008
Last updated: June 13, 2011
Last verified: June 2011
History of Changes

April 9, 2008
June 13, 2011
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 ] [ 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.
The amount of patients on Bortezomib that have maintained event-free survival will be compared to the patients on observation. [ Time Frame: three years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00657553 on ClinicalTrials.gov Archive Site
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
  • To determine if there is any increase in the amount of positive response when given Bortezomib alone. [ Time Frame: Three Years ] [ Designated as safety issue: No ]
  • To determine if Bortezomib will cause the reduction in MRI-defined focal lesions. [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • To evaluate whether Bortezomib will induce bone formation. [ Time Frame: Three years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00657553
100241
Yes
Bart Barlogie, MD, PhD, Myeloma Institute for Research and Therapy
University of Arkansas
Not Provided
Principal Investigator: Bart Barlogie, MD, PhD UAMS
University of Arkansas
June 2011

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