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Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00312845
First Posted: April 11, 2006
Last Update Posted: June 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
Results First Submitted: June 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Interventions: Drug: Bortezomib + Rituximab
Drug: Rituximab

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bortezomib + Rituximab 1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
Rituximab 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).

Participant Flow:   Overall Study
    Bortezomib + Rituximab   Rituximab
STARTED   336   340 
COMPLETED   237   245 
NOT COMPLETED   99   95 
Adverse Event                19                5 
Death                2                2 
Withdrawal by Subject                14                6 
Disease Progression                56                77 
Lost to Follow-up                2                0 
Other                6                5 



  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.
No text entered.

Reporting Groups
  Description
Bortezomib + Rituximab 1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
Rituximab 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
Total Total of all reporting groups

Baseline Measures
   Bortezomib + Rituximab   Rituximab   Total 
Overall Participants Analyzed 
[Units: Participants]
 336   340   676 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   243   242   485 
>=65 years   93   98   191 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.8  (11.12)   57.3  (12)   57  (11.56) 
Gender 
[Units: Participants]
     
Female   164   203   367 
Male   172   137   309 
Region of Enrollment 
[Units: Participants]
     
United States   14   16   30 
Portugal   11   12   23 
Slovakia   7   8   15 
Greece   1   1   2 
Thailand   2   1   3 
Spain   9   5   14 
Ukraine   13   11   24 
Israel   7   7   14 
Russian Federation   52   55   107 
Italy   14   15   29 
India   17   24   41 
France   13   10   23 
Australia   5   3   8 
South Africa   2   2   4 
China   46   40   86 
Korea, Republic of   4   3   7 
Finland   1   2   3 
United Kingdom   9   10   19 
Hungary   3   6   9 
Czech Republic   18   17   35 
Mexico   9   8   17 
Canada   9   10   19 
Argentina   2   5   7 
Brazil   18   21   39 
Belgium   18   19   37 
Poland   24   21   45 
Romania   6   2   8 
Germany   0   3   3 
Sweden   2   3   5 


  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information