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| Name | Class |
|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
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The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VDR | Experimental | VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) |
|
| VDCR | Experimental | VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) |
|
| VDC | Experimental | VELCADE (bortezomib), dexamethasone, cyclophosphamide |
|
| VDC-mod | Experimental | Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VELCADE (bortezomib) | Drug | bortezomib 1.3 mg/m^2 given via IV on days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on days 1, 8, 15 and 22 of a 6-week cycle for 4 cycles (maintenance). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Combined Complete Response and Very Good Partial Response | Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h | Up to 48 weeks or until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | Evaluate the safety and tolerability of the combination therapy | From first dose of study drug through the 30 day post-treatment AE assessment visit |
| Number of Patients With Overall Response |
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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 |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22422823 | Derived | Kumar S, Flinn I, Richardson PG, Hari P, Callander N, Noga SJ, Stewart AK, Turturro F, Rifkin R, Wolf J, Estevam J, Mulligan G, Shi H, Webb IJ, Rajkumar SV. Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma. Blood. 2012 May 10;119(19):4375-82. doi: 10.1182/blood-2011-11-395749. Epub 2012 Mar 15. | |
| 20508619 |
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| ID | Title | Description |
|---|---|---|
| FG000 | V-DR | VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| dexamethasone | Drug | dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop |
|
| cyclophosphamide | Drug | cyclophosphamide 500 mg/m^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop |
|
| Revlimid (lenalidomide) | Drug | lenalidomide 25 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDR arm) lenalidomide 15 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDCR arm) |
|
Overall Response includes complete response and partial response.
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour.
| Up to 48 weeks or until disease progression |
| Number of Patients With Stringent Complete Response Rate | Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. | Up to 48 weeks or until disease progression |
| Number of Patients With Complete Response Rate + Near Complete Response Rate | Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. | Up to 48 weeks or until disease progression |
| Duration of Response | Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments. Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas. | Up to 48 weeks or until disease progression |
| Time to Disease Progression | Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease. Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas. | Up to 48 weeks or until disease progression |
| Time to Response | Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments. | Up to 48 weeks or until disease response |
| Progression-free Survival | Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death. Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas. | Up to 48 weeks or until disease progression/death |
| Probability of 1-year Survival | survival probability at 1 year after randomization |
| Overall Survival | Overall survival is defined as time from the date of randomization to the date of death | Up to 48 weeks or until death |
| Rochester |
| Minnesota |
| 55904-0001 |
| United States |
| Derived |
| Kumar SK, Flinn I, Noga SJ, Hari P, Rifkin R, Callander N, Bhandari M, Wolf JL, Gasparetto C, Krishnan A, Grosman D, Glass J, Sahovic EA, Shi H, Webb IJ, Richardson PG, Rajkumar SV. Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study. Leukemia. 2010 Jul;24(7):1350-6. doi: 10.1038/leu.2010.116. Epub 2010 May 27. |
| FG001 | VDCR | VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop. |
| FG002 | V-DC | VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| FG003 | VDC-mod | Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V-DR | VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop. |
| BG001 | VDCR | VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop. |
| BG002 | V-DC | VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| BG003 | VDC-mod | Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Patients With Combined Complete Response and Very Good Partial Response | Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h | The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment. | Posted | Number | participants | Up to 48 weeks or until disease progression |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events (AEs) | Evaluate the safety and tolerability of the combination therapy | The safety population includes patients received any dose of any study drug. | Posted | Number | participants | From first dose of study drug through the 30 day post-treatment AE assessment visit |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Overall Response | Overall Response includes complete response and partial response. Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour. | The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment. | Posted | Number | participants | Up to 48 weeks or until disease progression |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Stringent Complete Response Rate | Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. | The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment. | Posted | Number | participants | Up to 48 weeks or until disease progression |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Complete Response Rate + Near Complete Response Rate | Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. | The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment. | Posted | Number | participants | Up to 48 weeks or until disease progression |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments. Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas. | Responders (patients achieved complete and partial response) in the response evaluable population. | Posted | Median | 95% Confidence Interval | days | Up to 48 weeks or until disease progression |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease. Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas. | The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug. | Posted | Median | 95% Confidence Interval | days | Up to 48 weeks or until disease progression |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments. | Responders (patients achieved complete and partial response) in the response evaluable population. | Posted | Median | Full Range | days | Up to 48 weeks or until disease response |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death. Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas. | The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug. | Posted | Median | 95% Confidence Interval | days | Up to 48 weeks or until disease progression/death |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Probability of 1-year Survival | The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug. | Posted | Number | percentage of patients | survival probability at 1 year after randomization |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as time from the date of randomization to the date of death | The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug. | Posted | Median | 95% Confidence Interval | days | Up to 48 weeks or until death |
|
From first dose of any study drug to 30-day post-treatment adverse event assessment, up to 48 weeks and 30 days
From first dose of any study drug to end of treatment period
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V-DR | VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop. | 17 | 42 | 41 | 42 | ||
| EG001 | VDCR | VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop. | 26 | 66 | 65 | 66 | ||
| EG002 | V-DC | VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. | 7 | 33 | 33 | 33 | ||
| EG003 | VDC-mod | Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. | 7 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Lobar pneumonia NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Urinary tract infection NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Respiratory syncytial virus infection NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Arthritis infective NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Colitis pseudomembranous | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Stye | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Small intestinal obstruction NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Diverticular perforation NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Antibiotic associated colitis | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Weakness | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Fall | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Neuralgia NOS | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Malnutrition NOS | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Back pain aggravated | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Venous thrombosis deep limb | Vascular disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pulmonary oedema NOS | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pericarditis NOS | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Renal impairment NOS | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Headache NOS | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Convulsions NOS | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (4.0) | Systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA (4.0) | Systematic Assessment |
| |
| Haemothorax | Injury, poisoning and procedural complications | MedDRA (4.0) | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (4.0) | Systematic Assessment |
| |
| Muscle injury NOS | Injury, poisoning and procedural complications | MedDRA (4.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (4.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (4.0) | Systematic Assessment |
| |
| Angioneurotic oedema | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypoproteinaemia | Hepatobiliary disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Caecitis | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Anaemia NOS | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Leukopenia NOS | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral neuropathy NOS | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dizziness (excl vertigo) | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hiccups | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Oedema lower limb | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Rigors | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pain NOS | General disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pruritus NOS | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Sweating increased | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Chest wall pain | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hyperglycaemia NOS | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Anxiety NEC | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Depression NOS | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (4.0) | Systematic Assessment |
| |
| Weight increased | Psychiatric disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (4.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (4.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (4.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Muscle cramps | Musculoskeletal and connective tissue disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Day mouth | Gastrointestinal disorders | MedDRA (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dixie-Lee Esseltine, MD | Millennium Pharmaceuticals, Inc | (617) 679-7000 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| D003520 | Cyclophosphamide |
| D000077269 | Lenalidomide |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| OG003 | VDC-mod | Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| OG002 | V-DC | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| V-DC |
Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| OG002 | V-DC | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| OG002 | V-DC | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| OG002 | V-DC | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.
Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| OG002 | V-DC | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|
| OG003 | VDC-mod | Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. |
|
|