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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:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00312845
First received: April 7, 2006
Last updated: June 19, 2012
Last verified: June 2012
Results First Received: June 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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
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Time Frame the end of study
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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).

Other Adverse Events
    Bortezomib + Rituximab   Rituximab
Total, other (not including serious) adverse events     
# participants affected / at risk   288/334 (86.23%)   232/339 (68.44%) 
Blood and lymphatic system disorders     
Thrombocytopenia † 1     
# participants affected / at risk   32/334 (9.58%)   13/339 (3.83%) 
Gastrointestinal disorders     
Abdominal pain upper † 1     
# participants affected / at risk   20/334 (5.99%)   7/339 (2.06%) 
General disorders     
Chills † 1     
# participants affected / at risk   28/334 (8.38%)   17/339 (5.01%) 
Fatigue † 1     
# participants affected / at risk   75/334 (22.46%)   27/339 (7.96%) 
Hepatobiliary disorders     
Hepatic function abnormal † 1     
# participants affected / at risk   16/334 (4.79%)   11/339 (3.24%) 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   22/334 (6.59%)   8/339 (2.36%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   37/334 (11.08%)   25/339 (7.37%) 
Pain in extremity † 1     
# participants affected / at risk   46/334 (13.77%)   15/339 (4.42%) 
Muscle spasms † 1     
# participants affected / at risk   16/334 (4.79%)   8/339 (2.36%) 
Myalgia † 1     
# participants affected / at risk   18/334 (5.39%)   5/339 (1.47%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   42/334 (12.57%)   24/339 (7.08%) 
Paraesthesia † 1     
# participants affected / at risk   39/334 (11.68%)   10/339 (2.95%) 
Dizziness † 1     
# participants affected / at risk   20/334 (5.99%)   9/339 (2.65%) 
Neuralgia † 1     
# participants affected / at risk   23/334 (6.89%)   1/339 (0.29%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   30/334 (8.98%)   18/339 (5.31%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   51/334 (15.27%)   31/339 (9.14%) 
Skin and subcutaneous tissue disorders     
Pruritus † 1     
# participants affected / at risk   25/334 (7.49%)   15/339 (4.42%) 
Rash † 1     
# participants affected / at risk   24/334 (7.19%)   10/339 (2.95%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   21/334 (6.29%)   9/339 (2.65%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)



  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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