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Trial record 67 of 1147 for:    "Follicular lymphoma"

A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma (VERTICAL)

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ClinicalTrials.gov Identifier: NCT00636792
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : June 22, 2011
Last Update Posted : January 13, 2012
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Follicular Lymphoma
Interventions Drug: VELCADE
Drug: Bendamustine
Drug: Rituximab
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VELCADE, Bendamustine, Rituximab (VBR) Treatment
Hide Arm/Group Description Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
Period Title: Overall Study
Started 73
Completed 40
Not Completed 33
Reason Not Completed
Adverse Event             16
Physician Decision             7
Progressive Disease             4
Withdrawal by Subject             3
Other             3
Arm/Group Title VELCADE, Bendamustine, Rituximab (VBR) Treatment
Hide Arm/Group Description Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
Overall Number of Baseline Participants 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
<=18 years
0
   0.0%
Between 18 and 65 years
49
  67.1%
>=65 years
24
  32.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants
59.8  (10.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
Female
29
  39.7%
Male
44
  60.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 73 participants
73
1.Primary Outcome
Title Number of Participants With Complete Response
Hide Description Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
Time Frame 12 weeks after the last subject completes their end of treatment visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population is defined at patients treated with 90 mg/m^2 bendamustine, received at least one dose of any study drug, and had at least one post baseline response assessment.
Arm/Group Title VELCADE, Bendamustine, Rituximab (VBR) Treatment
Hide Arm/Group Description:
Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
32
2.Secondary Outcome
Title Number of Participants With Overall Response (Complete and Partial Response)
Hide Description Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.
Time Frame 12 weeks after the last subject completes their end of treatment visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VELCADE, Bendamustine, Rituximab (VBR) Treatment
Hide Arm/Group Description:
Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
53
Time Frame Start from first dose of any study drug, end at 30 days post last dose of any study drug, or start of subsequent antineoplastic therapy, whichever occurs first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VELCADE, Bendamustine, Rituximab (VBR) Treatment
Hide Arm/Group Description Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
All-Cause Mortality
VELCADE, Bendamustine, Rituximab (VBR) Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VELCADE, Bendamustine, Rituximab (VBR) Treatment
Affected / at Risk (%)
Total   25/73 (34.25%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  3/73 (4.11%) 
Thrombocytopenia  1  2/73 (2.74%) 
Pancytopenia  1  1/73 (1.37%) 
Leukopenia NOS  1  1/73 (1.37%) 
Cardiac disorders   
Sinus tachycardia  1  1/73 (1.37%) 
Acute myocardial infarction  1  1/73 (1.37%) 
Gastrointestinal disorders   
Diarrhoea NOS  1  3/73 (4.11%) 
Nausea  1  3/73 (4.11%) 
Vomiting NOS  1  2/73 (2.74%) 
Ileus paralytic  1  1/73 (1.37%) 
Upper gastrointestinal haemorrhage  1  1/73 (1.37%) 
General disorders   
Pyrexia  1  3/73 (4.11%) 
Fatigue  1  1/73 (1.37%) 
Weakness  1  1/73 (1.37%) 
Disease progression NOS  1  1/73 (1.37%) 
Hepatobiliary disorders   
Cholecystitis acute NOS  1  1/73 (1.37%) 
Infections and infestations   
Pneumonia NOS  1  2/73 (2.74%) 
Bronchitis NOS  1  1/73 (1.37%) 
Pulmonary mycosis  1  1/73 (1.37%) 
Herpes zoster  1  1/73 (1.37%) 
Bacteraemia  1  1/73 (1.37%) 
Urinary tract infection NOS  1  1/73 (1.37%) 
Metabolism and nutrition disorders   
Dehydration  1  2/73 (2.74%) 
Hypercalcaemia  1  1/73 (1.37%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness NOS  1  1/73 (1.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour lysis syndrome  1  1/73 (1.37%) 
Nervous system disorders   
Syncope  1  1/73 (1.37%) 
Peripheral neuropathy NOS  1  1/73 (1.37%) 
Renal and urinary disorders   
Renal failure acute  1  1/73 (1.37%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  3/73 (4.11%) 
Dyspnoea NOS  1  2/73 (2.74%) 
Pneumonitis NOS  1  1/73 (1.37%) 
Skin and subcutaneous tissue disorders   
Dermatitis exfoliative NOS  1  1/73 (1.37%) 
Vascular disorders   
Orthostatic hypotension  1  1/73 (1.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VELCADE, Bendamustine, Rituximab (VBR) Treatment
Affected / at Risk (%)
Total   72/73 (98.63%) 
Blood and lymphatic system disorders   
Anaemia NOS  1  26/73 (35.62%) 
Neutropenia  1  25/73 (34.25%) 
Lymphopenia  1  4/73 (5.48%) 
Cardiac disorders   
Palpitations  1  4/73 (5.48%) 
Eye disorders   
Vision blurred  1  5/73 (6.85%) 
Eye irritation  1  4/73 (5.48%) 
Gastrointestinal disorders   
Constipation  1  33/73 (45.21%) 
Abdominal pain NOS  1  13/73 (17.81%) 
Abdominal pain upper  1  4/73 (5.48%) 
Stomatitis  1  9/73 (12.33%) 
Mouth ulceration  1  4/73 (5.48%) 
Pharyngolaryngeal pain  1  6/73 (8.22%) 
Flatulence  1  4/73 (5.48%) 
Dyspepsia  1  5/73 (6.85%) 
General disorders   
Rigors  1  27/73 (36.99%) 
Chest pain  1  4/73 (5.48%) 
Oedema lower limb  1  7/73 (9.59%) 
Infections and infestations   
Upper respiratory tract infection NOS  1  6/73 (8.22%) 
Herpes simplex  1  7/73 (9.59%) 
Oral candidiasis  1  7/73 (9.59%) 
Metabolism and nutrition disorders   
Anorexia  1  17/73 (23.29%) 
Appetite decreased NOS  1  4/73 (5.48%) 
Hypokalaemia  1  14/73 (19.18%) 
Hypomagnesaemia  1  6/73 (8.22%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  10/73 (13.70%) 
Pain in limb  1  6/73 (8.22%) 
Myalgia  1  9/73 (12.33%) 
Arthralgia  1  7/73 (9.59%) 
Nervous system disorders   
Dizziness (excl vertigo)  1  17/73 (23.29%) 
Dysgeusia  1  5/73 (6.85%) 
Headache NOS  1  20/73 (27.40%) 
Peripheral sensory neuropathy  1  10/73 (13.70%) 
Hypoaesthesia  1  4/73 (5.48%) 
Psychiatric disorders   
Insomnia  1  16/73 (21.92%) 
Anxiety NEC  1  9/73 (12.33%) 
Depression NOS  1  8/73 (10.96%) 
Renal and urinary disorders   
Urinary frequency  1  4/73 (5.48%) 
Dysuria  1  4/73 (5.48%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  14/73 (19.18%) 
Rhinitis allergic NOS  1  4/73 (5.48%) 
Skin and subcutaneous tissue disorders   
Pruritus NOS  1  6/73 (8.22%) 
Rash NOS  1  6/73 (8.22%) 
Night sweats  1  5/73 (6.85%) 
Skin lesion NOS  1  4/73 (5.48%) 
Vascular disorders   
Hypotension NOS  1  7/73 (9.59%) 
Phlebitis NOS  1  4/73 (5.48%) 
Hypertension NOS  1  4/73 (5.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (4.0)
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
Layout table for Results Point of Contact information
Name/Title: Carol Satler
Organization: Millennium Pharmaceutical Inc
Phone: (617) 551-3729
Layout table for additonal information
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00636792     History of Changes
Other Study ID Numbers: C05011
First Submitted: March 11, 2008
First Posted: March 14, 2008
Results First Submitted: May 31, 2011
Results First Posted: June 22, 2011
Last Update Posted: January 13, 2012