Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00084747
First received: June 10, 2004
Last updated: February 17, 2016
Last verified: February 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma and Plasma Cell Neoplasm
Intervention: Drug: bortezomib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bortezomib bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities

Participant Flow:   Overall Study
    Bortezomib  
STARTED     30  
COMPLETED     17  
NOT COMPLETED     13  
Relapsed                 8  
Death                 3  
Withdrawal by Subject                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bortezomib bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities

Baseline Measures
    Bortezomib  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     27  
>=65 years     3  
Gender  
[units: participants]
 
Female     16  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: signed consent to progression or end of trial. Up to 5 years. ]

2.  Secondary:   Overall Survival   [ Time Frame: up to 5 years from time of consent ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Dr. Gary Schiller
Organization: UCLA
phone: 310-206-5755
e-mail: gschiller@mednet.ucla.edu


Publications of Results:
Schiller GJ, Sohn JP, Malone P, et al.: Phase I/II trial of bortezomib maintenance following autologous peripheral blood progenitor cell transplantation as treatment for intermediate- and advanced-stage multiple myeloma. [Abstract] Biol Blood Marrow Transplant 13 (2 Suppl 1): A-153, 57, 2007.


Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00084747     History of Changes
Other Study ID Numbers: CDR0000365583
P30CA016042 ( US NIH Grant/Contract Award Number )
UCLA-0306106
MILLENNIUM-MM2003
Study First Received: June 10, 2004
Results First Received: January 20, 2016
Last Updated: February 17, 2016
Health Authority: United States: Food and Drug Administration