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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bortezomib
Hide Arm/Group Description bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
Period Title: Overall Study
Started 30
Completed 17
Not Completed 13
Reason Not Completed
Relapsed             8
Death             3
Withdrawal by Subject             2
Arm/Group Title Bortezomib
Hide Arm/Group Description bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  90.0%
>=65 years
3
  10.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
16
  53.3%
Male
14
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Progression-free Survival
Hide Description Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.
Time Frame signed consent to progression or end of trial. Up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib
Hide Arm/Group Description:
autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: months
29
(18 to 45)
2.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame up to 5 years from time of consent
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib
Hide Arm/Group Description:
bortezomib
Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: months
55
(16 to 86)
Time Frame Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bortezomib
Hide Arm/Group Description bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
All-Cause Mortality
Bortezomib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib
Affected / at Risk (%) # Events
Total   2/30 (6.67%)    
General disorders   
Nausea/Dehydration *  1/30 (3.33%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  1/30 (3.33%)  2
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bortezomib
Affected / at Risk (%) # Events
Total   19/30 (63.33%)    
Gastrointestinal disorders   
Dyspepsia *  1/30 (3.33%)  1
Diarrhea *  7/30 (23.33%)  7
Constipation *  3/30 (10.00%)  3
General disorders   
Fatigue *  19/30 (63.33%)  19
Anorexia *  1/30 (3.33%)  1
nausea/vomiting *  9/30 (30.00%)  9
Neuropathy *  11/30 (36.67%)  11
Pain *  17/30 (56.67%)  17
Peripheral Edema *  1/30 (3.33%)  1
Rash *  2/30 (6.67%)  2
Neutrophils *  6/30 (20.00%)  6
Platelets *  10/30 (33.33%)  10
Right extremity swelling, with no DVT * [1]  1/30 (3.33%)  1
Immune system disorders   
Herpes Zoster Reactivation *  7/30 (23.33%)  7
Infections and infestations   
Fever *  1/30 (3.33%)  1
Cough *  4/30 (13.33%)  4
Upper Respiratory Infection *  2/30 (6.67%)  2
Transaminits 2/2 Hep A from contaminated food * [2]  1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
not drug related
[2]
not related
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
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