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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arms and Interventions
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Arm Intervention/treatment
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
 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
No Intervention: Observation Arm (watchful waiting)
monitor myeloma parameters every 3-6 months


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657553


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Bart Barlogie, MD, PhD UAMS
More Information
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00657553    
Other Study ID Numbers: 100241
First Posted: April 14, 2008    Key Record Dates
Results First Posted: July 12, 2011
Last Update Posted: November 20, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents