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
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

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 [ 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.



Secondary Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657553

Locations
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
Principal Investigator: Bart Barlogie, MD, PhD UAMS
  More Information

No publications provided

Responsible Party: Bart Barlogie, MD, PhD, Myeloma Institute for Research and Therapy
ClinicalTrials.gov Identifier: NCT00657553     History of Changes
Other Study ID Numbers: 100241
Study First Received: April 9, 2008
Results First Received: April 14, 2011
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014