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
  Hide 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
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
  Hide 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 + 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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide Other Adverse Events

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     232/339  
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
  Hide 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
No text entered.


  More Information