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This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VELCADE | Drug | VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. | 12 weeks after the last subject completes their end of treatment visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Response (Complete and Partial Response) | 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. | 12 weeks after the last subject completes their end of treatment visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20057 | United States | ||
| MidDakota Clinic - Cancer Treatment and Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | VELCADE, Bendamustine, Rituximab (VBR) Treatment | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bendamustine | Drug | Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle |
|
| Rituximab | Drug | Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5 |
|
| Bismarck |
| North Dakota |
| 58501 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VELCADE, Bendamustine, Rituximab (VBR) Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Complete Response | Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. | 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. | Posted | Number | participants | 12 weeks after the last subject completes their end of treatment visit. |
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| Secondary | Number of Participants With Overall Response (Complete and Partial Response) | 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. | Posted | Number | participants | 12 weeks after the last subject completes their end of treatment visit |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VELCADE, Bendamustine, Rituximab (VBR) Treatment | 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. | 25 | 73 | 72 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Bronchitis NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Urinary tract infection NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
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| Leukopenia NOS | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Vomiting NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (4.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (4.0) | Systematic Assessment |
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| Weakness | General disorders | MedDRA (4.0) | Systematic Assessment |
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| Disease progression NOS | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Peripheral neuropathy NOS | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
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| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
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| Cholecystitis acute NOS | Hepatobiliary disorders | MedDRA (4.0) | Systematic Assessment |
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| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
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| Tumour lysis syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (4.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Pharyngolaryngeal pain | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Rigors | General disorders | MedDRA (4.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Oedema lower limb | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dizziness (excl vertigo) | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
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| Headache NOS | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
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| Anaemia NOS | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pruritus NOS | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
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| Skin lesion NOS | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
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| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
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| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
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| Upper respiratory tract infection NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Rhinitis allergic NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
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| Anxiety NEC | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
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| Depression NOS | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
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| Hypotension NOS | Vascular disorders | MedDRA (4.0) | Systematic Assessment |
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| Phlebitis NOS | Vascular disorders | MedDRA (4.0) | Systematic Assessment |
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| Hypertension NOS | Vascular disorders | MedDRA (4.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (4.0) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (4.0) | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol Satler | Millennium Pharmaceutical Inc | (617) 551-3729 |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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