Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
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Time Frame the end of study
Additional Description 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).

Serious Adverse Events
    Bortezomib + Rituximab   Rituximab
Total, serious adverse events     
# participants affected / at risk   59/334 (17.66%)   37/339 (10.91%) 
Blood and lymphatic system disorders     
Febrile neutropenia † 1     
# participants affected / at risk   5/334 (1.50%)   3/339 (0.88%) 
Neutropenia † 1     
# participants affected / at risk   2/334 (0.60%)   2/339 (0.59%) 
Bone marrow failure † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Leukopenia † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Anaemia † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Lymphadenopathy † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Cardiac disorders     
Left entricular dysfunction † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Palpitations † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Pericardial effusion † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Right ventricular dysfunction † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Acute myocardial infarction † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Angina unstable † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Cardiac failure acute † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Cardiogenic shock † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Coronary artery disease † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Cyanosis † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Tachycardia † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   5/334 (1.50%)   2/339 (0.59%) 
Vomiting † 1     
# participants affected / at risk   4/334 (1.20%)   1/339 (0.29%) 
Abdominal pain † 1     
# participants affected / at risk   2/334 (0.60%)   2/339 (0.59%) 
Colonic obstruction † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Enteritis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Gastrointestinal obstruction † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Constipation † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Dysphagia † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Nausea † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Periodontitis † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Toothache † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
General disorders     
Pyrexia † 1     
# participants affected / at risk   6/334 (1.80%)   2/339 (0.59%) 
Asthenia † 1     
# participants affected / at risk   1/334 (0.30%)   2/339 (0.59%) 
Chest pain † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Oedema peripheral † 1     
# participants affected / at risk   1/334 (0.30%)   1/339 (0.29%) 
Pain † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Chest discomfort † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Hepatobiliary disorders     
Cholangitis acute † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Cholecystitis acute † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Cirrhosis alcoholic † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Immune system disorders     
Hypersensitivity † 1     
# participants affected / at risk   4/334 (1.20%)   1/339 (0.29%) 
Anaphylactic reaction † 1     
# participants affected / at risk   2/334 (0.60%)   0/339 (0.00%) 
Infections and infestations     
Pneumonia † 1     
# participants affected / at risk   7/334 (2.10%)   3/339 (0.88%) 
Herpes zoster † 1     
# participants affected / at risk   4/334 (1.20%)   0/339 (0.00%) 
Sepsis † 1     
# participants affected / at risk   3/334 (0.90%)   0/339 (0.00%) 
Urinary tract infection † 1     
# participants affected / at risk   0/334 (0.00%)   2/339 (0.59%) 
Bronchopneumonia † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Clostridial infection † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Empyema † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Laryngitis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Lower respiratory tract infection † 1     
# participants affected / at risk   1/334 (0.30%)   1/339 (0.29%) 
Meningitis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Necrotixing fasciitis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Pharyngitis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Tracheobronchitis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Aspergillosis † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Gastroenteritis salmonella † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Hepatitis B † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Hepatitis viral † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Herpes virus infection † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Pyelonephritis † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Respiratory tract infection † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Septic shock † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Injury, poisoning and procedural complications     
Collapse of lung † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Concussion † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Pelvic fracture † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Upper limb fracture † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   2/334 (0.60%)   0/339 (0.00%) 
Decreased appetite † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Hyperglycaemia † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Hyperkalaemia † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Hyponatraemia † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign breast neoplasm † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Tumour necrosis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Rectal cancer † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Nervous system disorders     
Cerebrovascular accident † 1     
# participants affected / at risk   2/334 (0.60%)   0/339 (0.00%) 
Convulsion † 1     
# participants affected / at risk   1/334 (0.30%)   1/339 (0.29%) 
Dementia † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Somnolence † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Loss of consciousness † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Myelopathy † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Peripheral sensory neuropathy † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Syncope † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Toxic encephalopathy † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Psychiatric disorders     
Confusional state † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Renal and urinary disorders     
Renal failure † 1     
# participants affected / at risk   2/334 (0.60%)   0/339 (0.00%) 
Calculus urinary † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Renal failure acute † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Renal impairment † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion † 1     
# participants affected / at risk   2/334 (0.60%)   2/339 (0.59%) 
Hypoxia † 1     
# participants affected / at risk   2/334 (0.60%)   0/339 (0.00%) 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Chylothorax † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Dyspnoea † 1     
# participants affected / at risk   1/334 (0.30%)   1/339 (0.29%) 
Epistaxis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Pulmonary embolism † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Acute respiratory failure † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Pleural haemorrhage † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Pneumothorax † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Seborrhoeic dermatitis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Urticaria † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Hyperhidrosis † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Vascular disorders     
Hypotension † 1     
# participants affected / at risk   4/334 (1.20%)   0/339 (0.00%) 
Deep vein thrombosis † 1     
# participants affected / at risk   0/334 (0.00%)   1/339 (0.29%) 
Orthostatic hypotension † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Subclavian vein thrombosis † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Thrombosis † 1     
# participants affected / at risk   1/334 (0.30%)   0/339 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)




  Other Adverse Events


  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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