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| ID | Type | Description | Link |
|---|---|---|---|
| STU00004871 | Other Identifier | Northwestern University IRB |
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Study was closed permanently before the accrual goal was met due to slow accrual
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| Name | Class |
|---|---|
| Robert H. Lurie Cancer Center | OTHER |
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Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
This phase I/II trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.
This is a phase I, dose-escalation study of bortezomib followed by a phase II study.
Phase I:
- Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22, rituximab IV on days 8 and 15, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 15.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
- Consolidation therapy: Beginning 6-7 weeks after completing induction therapy, patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Phase II: Patients receive induction therapy and consolidation therapy as in phase I, with bortezomib administered at the MTD determined in phase I.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
A total of 24 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bortezomib, Ibritumomab tiuxetan, rituximab | Experimental | Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Drug | Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Tolerability of Bortezomib Combined With Y-90-Ibritumomab Tiuxetan Determined by Number of Dose Limiting Toxicities in a Cohort. | To determine the MTD using a 3+3 dose escalating design. There will be 3 dose cohorts:1.0mg/m2,1.3mg/m2 and1.6 mg/m2. 3 patients will be enrolled at dose of 1.0mg/m2 bortezomib. If no dose limiting toxicities (DLTs) are seen in the first 3 patients then dose will be escalated to next level and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0. DLTs=grade 3 nausea, vomiting, diarrhea or ileus more than 96h; grade 4 nausea, vomiting, diarrhea or ileus,neuropathic pain, peripheral sensory neuropathy, neutropenia, thrombocytopenia. | During induction therapy, the first 28 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events Related to Treatment of Bortezomib Combined With Y-90-ibritumomab Tiuxetan | To further explore the toxicity bortezomib combined with Y-90-ibritumomab tiuxetan by collecting data on adverse events (AE) reported by patient or collected lab results that are grade 3 or grade 4 that were determined to be at least possible related to any of the studies drugs. Toxicity will be collected on treatment days according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Winter, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States | ||
| Northwestern University |
Not provided
The study opened for accrual on August 11, 2006 with an accrual goal of up to 24 patients. Accrual was suspended on September 9 2009 and reopened on November 30, 2009. The study was closed permanently on August 15, 2013 due to slow accrual with 18 patients enrolled and 17 patients treated on study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: 1.0mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| FG001 | Cohort 2: 1.3mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| FG002 | Cohort 3: 1.6mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| FG003 | Expansion Phase: 1.3mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose (MTD), or as the determined MTD in the expansion phase. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1: Dose Level 1.0mg/m2 |
|
| |||||||||||||||||||||||||||
| Cohort 2: Dose Level 1.3mg/m2 |
| ||||||||||||||||||||||||||||
| Cohort 3: Dose Level 1.6mg/m2 |
| ||||||||||||||||||||||||||||
| Expansion Phase at Dose 1.3mg/m2 |
| ||||||||||||||||||||||||||||
| Follow up Until Relapse or Progression |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bortezomib, Ibritumomab Tiuxetan, Rituximab | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Tolerated Dose (MTD) and Tolerability of Bortezomib Combined With Y-90-Ibritumomab Tiuxetan Determined by Number of Dose Limiting Toxicities in a Cohort. | To determine the MTD using a 3+3 dose escalating design. There will be 3 dose cohorts:1.0mg/m2,1.3mg/m2 and1.6 mg/m2. 3 patients will be enrolled at dose of 1.0mg/m2 bortezomib. If no dose limiting toxicities (DLTs) are seen in the first 3 patients then dose will be escalated to next level and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0. DLTs=grade 3 nausea, vomiting, diarrhea or ileus more than 96h; grade 4 nausea, vomiting, diarrhea or ileus,neuropathic pain, peripheral sensory neuropathy, neutropenia, thrombocytopenia. | Patients enrolled in dose escalation cohorts 1, 2 and 3 analyzed for this outcome measure. | Posted | Number | DLT | During induction therapy, the first 28 days of treatment. |
Adverse events (AE) for the study were collected over a 5 year period. AEs for each patient were collected during treatment through 30 days post last treatment. Treatment consisted of one 28 day induction cycle followed by 71 day recovery period and then a maximum of 3 consolidation cycles each of 28 days.
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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 | Cohort 1: 1.0mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis (non infectious) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
The study closed permanently due to slow accrual with only 17 patients treated on study. This was before the expected accrual goal of 24 patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Winter, MD | Northwestern University | 312 695 4033 | Jwinter@nm.org |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069286 | Bortezomib |
| C422802 | ibritumomab tiuxetan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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Not provided
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Not provided
|
|
| bortezomib | Drug | Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
|
|
| Ibritumomab tiuxetan | Drug | Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
|
|
| At start of treatment on days 1, 8, 15, 22 of induction, days 36 and 50 of recovery, days 1, 8, 15 of consolidation cycles for up to 3 cycles and 4 weeks after the completion of treatment. |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Registered to Study |
|
| Treated 1 Cycle of Induction Therapy |
|
| Completed 3 Cycles of Consolidation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Registered |
|
| Treated 1 Cycle of Induction Therapy |
|
| Completed 3 Cycles of Consolidation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Registration |
|
| Treated 1 Cycle Induction Therapy |
|
| Completed 3 Cycles of Consolidation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Cohort 1: 1.0mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| OG001 | Cohort 2: 1.3mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
| OG002 | Cohort 3: 1.6mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. |
|
|
| Secondary | Number of Patients With Adverse Events Related to Treatment of Bortezomib Combined With Y-90-ibritumomab Tiuxetan | To further explore the toxicity bortezomib combined with Y-90-ibritumomab tiuxetan by collecting data on adverse events (AE) reported by patient or collected lab results that are grade 3 or grade 4 that were determined to be at least possible related to any of the studies drugs. Toxicity will be collected on treatment days according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Toxicity data for 9 patients enrolled in the dose escalating cohorts 1, 2 and 3 was collected and analyzed only. Data for the 3 cohorts are presented combined as the objective is to report grade 3 and 4 toxicities with this combination of drugs (dose of bortezomib is irrelevant) | Posted | Count of Participants | Participants | At start of treatment on days 1, 8, 15, 22 of induction, days 36 and 50 of recovery, days 1, 8, 15 of consolidation cycles for up to 3 cycles and 4 weeks after the completion of treatment. |
|
|
|
| Post-Hoc | Overall Response Rate | The overall response rate at the completion of treatment was defined as complete response plus partial response. Complete response (CR)=A post-treatment residual mass of any size is permitted as long as it is PET-negative and normalization of those biochemical abnormalities. Partial response (PR)=50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in the size of the other nodes, liver or spleen, and no new sites of disease. Stable disease=Failing to attain the criteria for PR or CR, but not fulfilling those for progressive disease. Progressive disease(PD)=At least a 50% increase from nadir in the SPD of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. | Data for first 9 patients enrolled in phase I dose escalation portion of the study were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the ORR of patients with this drug combination (dose was irrelevant) | Posted | Number | percentage of patients | At baseline, after induction cycle (1 cycle =28 days) and consolidation therapy of a maximum of 3 cycles (1cycle =28 days), up to approximately 6 months |
|
|
|
| Post-Hoc | Median Progression Free Survival | Median progression free survival (PFS) will be assessed by CT scans after induction therapy, consolidation therapy, every 3 months for the first year following treatment and every 6 months for the second year. Progressive disease is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size or at least a 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. | The first 9 patients data that were enrolled in the phase I dose escalation portion were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the PFS of patients with this drug combination (dose was irrelevant) | Posted | Median | Full Range | Months | At start of treatment, at completion of induction therapy, at completion of consolidation therapy, every 3 months for 1 year, and every 6 months for 1 year |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2: 1.3mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. | 1 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Cohort 3: 1.6mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Expansion Phase: 1.3mg/m2 Bortezomib | Induction therapy will last one cycle of 28 days. Bortezomib will be given on days 1, 8, 15, and 22. 250mg/m2 of Rituximab will be given on days 8 and 15. 0.4mCi/kg of y-90-ibritumomab tiuxetan will be given on day 15. During induction therapy patients will receive either 1.0mg/m2, 1.3mg/m2, or 1.6mg/m2 of bortezomib as the study is designed as a 3+3 dose escalation of bortezomib to find the maximum tolerated dose (MTD) or at the determined MTD in the expansion phase. Consolidation therapy will last a maximum of 3 cycles and will start on day 71 (1 cycle = 28 days) During consolidation therapy, 1.6mg/m2 of Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy. | 1 | 8 | 1 | 8 | 8 | 8 |
| Hearing loss | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin (anemia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils (neutropenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes (total white blood cells) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets (thrombocytopenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac NOS | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Brusing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritis/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shingles | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes/flushes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cavity - Root canal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Distension/bloating abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stomach upset | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematoma | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nose bleed | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Bronchus infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Sinus infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Cellulitis (skin rash) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Edema in limb(s) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema of trunk/gential | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema of head/neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Transaminase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT increase (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilirubin increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lactic acid dehydrogenase increase (LDH) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Potassium, serum high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Potassium, serum low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium, serum high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Uric acid, serum high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety (Mood alteration) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Agitation (Mood alteration) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Syncope (Fainting episode) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flank pain | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mid thoracic pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain in groin | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shortness of breath (dyspnea) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 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 |
| Title | Measurements |
|---|---|
|
| Thrombocytopenia |
|
| Cardiac |
|