Not provided
Not provided
Not provided
Not provided
Not provided
Lack of accrual
Not provided
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| Name | Class |
|---|---|
| Hoosier Cancer Research Network | OTHER |
| Cephalon, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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Not provided
This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.
Phase I component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine escalating cohorts IV over 1 hour, Days 1 and 4 1 Cycle = 28 days
Phase II component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine at MTD IV over 1 hour, Days 1 and 4 Filgrastim (if defined in MTD) 5 µg/kg/day SC, Starting day 6 until neutrophil recovery to ANC >1000
1 Cycle = 28 days; Patients will continue treatment for a total of up to 8 cycles.
ECOG Performance Status: 0-2
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Bendamustine in combination with bortezomib and pegylated liposomal doxorubicin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | Phase I component: Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin. | In the first phase, MTD of bendamustine was determined in combination with bortezomib and pegylated liposomal doxorubicin to gain a better idea of safe dosing before proceeding with the second phase to assess efficacy. Assuming myelosuppression being a dose-limiting effect that could have been overcome with growth factor support, MTD of the combination with myeloid growth factor support was also tested. | From C1D1 up to a maximum of 7 months or until death |
| Phase II : Overall Response Rate | Overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin was assessed in patients with relapsed or refractory Multiple Myeloma. Per modified International Myeloma Working Group criteria: Complete Response (CR) : Negative for monoclonal protein by immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow ; PR : 50% or more reduction in serum M-protein and 90% or more reduction in urine M-protein or to <200 mg/24hours or a 50% or more reduction in free light chain level ; Overall Response (OR) = CR +PR. | From C1D1 up to a maximum of 52 months or until death |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I & Phase II : Toxicity of Treatment Regimen | Toxicity profile (for all patients) were presented by rate of overall toxicity and rates of grade 3 or 4 toxicities analyzed separately and combined. | From C1D1 until death or up to a maximum of 54 months |
| Phase II : Time to Progression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherif Farag, M.B., B.S. | Hoosier Cancer Research Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
Not provided
| Label | URL |
|---|---|
| Hoosier Oncology Group Homepage | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Treatment |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2014 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Doxorubicin | Drug | Phase I and II components: Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4 |
|
| Bortezomib | Drug | Phase I and II components: Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 |
|
| Bendamustine | Drug | Phase II component: Bendamustine at at MTD IV over 1 hour, Days 1 and 4 |
|
| Filgrastim | Drug | Phase II component: Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000 |
|
The time from the start of treatment (i.e., first dose) of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin to disease progression, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date for patient without progression/death or date of death due to other diseases for patients' deaths due to other causes.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met: Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; Development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas;Development of hyperc. |
| From C1D1 up to a maximum of 54 months or until death |
| Phase II: Progression-free Survival (PFS) | The time from the start of treatment of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. to disease progression or death (regardless of cause of death), whichever comes first. Censoring date will be the last disease evaluation date.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met: Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; Development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas;Development of hyperc. | From C1D1 up to a maximum of 54 months until death |
| Phase II: Duration of Survival | Duration of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. from first date of at least partial response to the time of progression or death due to disease progression as events, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date or date of death due to other causes as appropriate. | From C1D1 up to a maximum of 52 months |
| Phase II: Overall Survival | The time from the start of treatment to death from any cause with last date known alive as censoring date. | From C1D1 up to a maximum of 54 months or until death |
| IU Health Central Indiana Cancer Centers |
| Indianapolis |
| Indiana |
| 46219 |
| United States |
| Community Regional Cancer Center | Indianapolis | Indiana | 46256 | United States |
| IU Health Arnett Cancer Center | Lafayette | Indiana | 47904 | United States |
| Metro Health Cancer Care | Wyoming | Michigan | 49519 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44106 | United States |
| FG001 | Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle. |
| FG002 | Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At phase II, Bendamustine will be administered at 90mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle. |
| BG001 | Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle. |
| BG002 | Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At phase II, Bendamustine will be administered at 90mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle. |
| BG003 | 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, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status (Baseline | ECOG PERFORMANCE STATUS: 0 Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | 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 | Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin. | In the first phase, MTD of bendamustine was determined in combination with bortezomib and pegylated liposomal doxorubicin to gain a better idea of safe dosing before proceeding with the second phase to assess efficacy. Assuming myelosuppression being a dose-limiting effect that could have been overcome with growth factor support, MTD of the combination with myeloid growth factor support was also tested. | Posted | Number | mg/m^2 | From C1D1 up to a maximum of 7 months or until death |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Phase II : Overall Response Rate | Overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin was assessed in patients with relapsed or refractory Multiple Myeloma. Per modified International Myeloma Working Group criteria: Complete Response (CR) : Negative for monoclonal protein by immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow ; PR : 50% or more reduction in serum M-protein and 90% or more reduction in urine M-protein or to <200 mg/24hours or a 50% or more reduction in free light chain level ; Overall Response (OR) = CR +PR. | Two subjects never received treatment. Therefore, they were not included in any assessment of objectives. | Posted | Count of Participants | Participants | From C1D1 up to a maximum of 52 months or until death |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase I & Phase II : Toxicity of Treatment Regimen | Toxicity profile (for all patients) were presented by rate of overall toxicity and rates of grade 3 or 4 toxicities analyzed separately and combined. | Two subjects in phase II never received treatment. Therefore, they were not included in any assessment of objectives. | Posted | Count of Participants | Participants | From C1D1 until death or up to a maximum of 54 months |
| |||||||||||||||||||||||||||||||
| Secondary | Phase II : Time to Progression | The time from the start of treatment (i.e., first dose) of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin to disease progression, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date for patient without progression/death or date of death due to other diseases for patients' deaths due to other causes.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met: Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; Development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas;Development of hyperc. | Two subjects never received treatment. Therefore, they were not included in any assessment of objectives. | Posted | Median | 95% Confidence Interval | months | From C1D1 up to a maximum of 54 months or until death |
| ||||||||||||||||||||||||||||||
| Secondary | Phase II: Progression-free Survival (PFS) | The time from the start of treatment of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. to disease progression or death (regardless of cause of death), whichever comes first. Censoring date will be the last disease evaluation date.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met: Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; Development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas;Development of hyperc. | Two subjects never received treatment. Therefore, they were not included in any assessment of objectives. | Posted | Median | 95% Confidence Interval | months | From C1D1 up to a maximum of 54 months until death |
| ||||||||||||||||||||||||||||||
| Secondary | Phase II: Duration of Survival | Duration of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. from first date of at least partial response to the time of progression or death due to disease progression as events, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date or date of death due to other causes as appropriate. | Two subjects never received treatment. Therefore, they were not included in any assessment of objectives. | Posted | Median | 95% Confidence Interval | months | From C1D1 up to a maximum of 52 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Phase II: Overall Survival | The time from the start of treatment to death from any cause with last date known alive as censoring date. | Two subjects never received treatment. Therefore, they were not included in any assessment of objectives. | Posted | Median | 95% Confidence Interval | months | From C1D1 up to a maximum of 54 months or until death |
|
|
From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 54 months.
Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment.
SAEs must be reported during the course of the study within 24 hours of discovery of the event.
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 | Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle. | 2 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At phase II, Bendamustine will be administered at 90mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle. | 7 | 26 | 8 | 26 | 24 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Colon | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| CALCIUM, SERUM-HIGH (HYPERCALCEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DEHYDRATION | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ENTERITIS (INFLAMMATION OF THE SMALL BOWEL) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| GASTROINTESTINAL - OTHER (SPECIFY, __) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HYPOTENSION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION (MENINGITIS) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION - OTHER (SPECIFY, __) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SODIUM, SERUM-LOW (HYPONATREMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Hearing: patients without baseline audiogram and not enrolled in a monitoring program | Ear and labyrinth disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Esophagus | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Back | Renal and urinary disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Bone | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Chest wall | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Extremity-limb | Injury, poisoning and procedural complications | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Eye | Eye disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Head/headache | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Oral cavity | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Stomach | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Trismus (difficulty, restriction or pain when opening mouth) | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Weight loss | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Infection - Urinary tract NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __) | Eye disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pain - Other (Specify, __) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | Immune system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ALLERGY/IMMUNOLOGY - OTHER (SPECIFY, __) | Immune system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ANOREXIA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ARTHRITIS (NON-SEPTIC) | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| AUDITORY/EAR - OTHER (SPECIFY, __) | Ear and labyrinth disorders | CTCAEv3 | Non-systematic Assessment |
| |
| BILIRUBIN (HYPERBILIRUBINEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA) | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CALCIUM, SERUM-HIGH (HYPERCALCEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CALCIUM, SERUM-LOW (HYPOCALCEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTEREMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CONFUSION | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CREATININE | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DEHYDRATION | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DERMATOLOGY/SKIN - OTHER (SPECIFY, __) | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DISTENSION/BLOATING, ABDOMINAL | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DRY EYE SYNDROME | Eye disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| EDEMA:HEAD AND NECK | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| EDEMA:LIMB | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ENDOCRINE - OTHER (SPECIFY, __) | Endocrine disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| GASTROINTESTINAL - OTHER (SPECIFY, __) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| GLOMERULAR FILTRATION RATE | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HEMOGLOBIN | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI - ANUS | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HYPERTENSION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HYPOTENSION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION- SKIN (CELLULITIS) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION - OTHER (SPECIFY, __) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - DUODENUM | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - MUCOSA | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - NERVE-PERIPHERAL | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ORAL CAVITY-GUMS (GINGIVITIS) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AERODIGESTIVE NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INJECTION SITE REACTION/EXTRAVASATION CHANGES | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| INSOMNIA | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| LEUKOCYTES (TOTAL WBC) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| LYMPHATICS - OTHER (SPECIFY, __) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| METABOLIC/LABORATORY - OTHER (SPECIFY, __) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MOOD ALTERATION - AGITATION | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MOOD ALTERATION - ANXIETY | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MOOD ALTERATION - DEPRESSION | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ESOPHAGUS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ESOPHAGUS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - WHOLE BODY/GENERALIZED | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| NEUROLOGY - OTHER (SPECIFY, __) | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| NEUROPATHY: SENSORY | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| NEUTROPHILS/GRANULOCYTES (ANC/AGC) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - ABDOMEN NOS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - BACK | Renal and urinary disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - BONE | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - CHEST/THORAX NOS | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - EXTREMITY-LIMB | Injury, poisoning and procedural complications | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - HEAD/HEADACHE | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - JOINT | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - MUSCLE | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - NECK | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - OTHER (SPECIFY, __) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - PAIN NOS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - THROAT/PHARYNX/LARYNX | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS) | Vascular disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PLATELETS | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION (NON-MALIGNANT) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS) | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SODIUM, SERUM-LOW (HYPONATREMIA) | Metabolism and nutrition disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SYNCOPE (FAINTING) | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| THROMBOTIC MICROANGIOPATHY | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ULCER, GI - ESOPHAGUS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| URINARY FREQUENCY/URGENCY | Renal and urinary disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VASCULAR - OTHER (SPECIFY, __) | Vascular disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VISION-BLURRED VISION | Eye disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| WEIGHT LOSS | General disorders | CTCAEv3 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annesha Majumdar | Hoosier Cancer Research Network | 3179212050 | amajumdar@hoosiercancer.org |
| Aug 18, 2023 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D004317 | Doxorubicin |
| D000069286 | Bortezomib |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Study closed by Sponsor due slow enrollment. |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| Participants |
|
|
| OG002 | Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | Bendamustine: At phase II, Bendamustine will be administered at 90mg/m^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|