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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
Results First Received: April 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Bortezomib

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Treatment Arm Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
Observation Arm Patients will be observed for progress over the course of three years.
Total Total of all reporting groups

Baseline Measures
    Treatment Arm     Observation Arm     Total  
Number of Participants  
[units: participants]
 		  5     5     10  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     2     2     4  
>=65 years     3     3     6  
Age  
[units: years]
Mean ± Standard Deviation 		  61.6  ± 7.89     64.4  ± 7     63  ± 7.3  
Gender  
[units: participants]
 		     
Female     2     3     5  
Male     3     2     5  



  Outcome Measures

1.  Primary:   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 ]
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2.  Secondary:   Response Rate of Participants Given Bortezomib Alone   [ Time Frame: Three Years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed  


Results Point of Contact:  
Name/Title: Nathan M. Petty
Organization: University of Arkansas for Medical Sciences, Myeloma Institute
phone: 501-569-6990 ext 2461
e-mail: pettynathanm@uams.edu


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