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

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ClinicalTrials.gov Identifier: NCT00084747
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma and Plasma Cell Neoplasm
Intervention: Drug: bortezomib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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.
No text entered.

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 
Overall Participants Analyzed 
[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

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

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

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 ( U.S. NIH Grant/Contract )
UCLA-0306106
MILLENNIUM-MM2003
First Submitted: June 10, 2004
First Posted: June 11, 2004
Results First Submitted: January 20, 2016
Results First Posted: March 15, 2016
Last Update Posted: March 15, 2016