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The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDAâ„¢), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.
Bendamustine (TREANDAâ„¢) has been used in clinical trials to treat multiple myeloma. The results from these trials suggest that it may be beneficial in the treatment of multiple myeloma in a different treatment context. Researchers aim to determine if there may be an improved benefit in the context of bone marrow transplant. This initial clinical trial is intended to help determine how safe it is to use bendamustine as a conditioning regimen for bone marrow transplant, and to look for any initial evidence of benefit.
Bendamustine (TREANDAâ„¢) is approved by the Food and Drug Administration (FDA) for the treatment of Chronic Lymphocytic Leukemia and Melphalan is a type of chemotherapy drug.
The use of Melphalan alone as a conditioning regimen for Autologous Stem Cell Transplant is considered "Standard of Care," that is, the treatment or process that your doctor would normally follow to treat your disease. Although Bendamustine (TREANDAâ„¢) has been used in multiple myeloma research studies, the combination of Bendamustine (TREANDAâ„¢) and Melphalan as treatment for Multiple Myeloma is not approved by the FDA, thus the combination therapy used in this research study is considered "investigational."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | Dose Level 1; Bendamustine 30 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) |
|
| Dose Level 2 | Experimental | Dose Level 2; Bendamustine 60 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) |
|
| Dose Level 3 | Experimental | Dose Level 3; Bendamustine 90 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) |
|
| Dose Level 4 | Experimental | Dose Level 4; Bendamustine 120 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) |
|
| Dose Level 5 | Experimental | Dose Level 5; Bendamustine 150 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | 30 mg/m^2 given on day 2 of melphalan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (Phase 1) | The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm^3 and platelet count of 20,000/mm^3 untransfused by Day 35 post-transplant. | 35 days post-transplant |
| Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant | Number of patients achieving at least a partial response or better in disease status at Day 100 post-transplant, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Partial response in disease status is defined by the IMWG as ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours; If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required | 100 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (Phase 1) | Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of >25% from lowest response value in any one or more of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsiporah Shore, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31190006 | Derived | Gomez-Arteaga A, Mark TM, Guarneri D, Christos PJ, Gergis U, Greenberg JD, Hsu J, Mayer SA, Niesvizky R, Pearse RN, Phillips AA, Rossi A, Coleman M, van Besien K, Shore TB. High-dose bendamustine and melphalan conditioning for autologous stem cell transplantation for patients with multiple myeloma. Bone Marrow Transplant. 2019 Dec;54(12):2027-2038. doi: 10.1038/s41409-019-0587-0. Epub 2019 Jun 12. |
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Four subjects were ineligible and therefore never started treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 | Dose Level 1; Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) Bendamustine: 30 mg/m2 given on day 2 of melphalan Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
|
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|
| Dose Level 6 | Experimental | Dose Level 6; Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) |
|
| Phase 2 | Experimental | Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) |
|
| Melphalan | Drug | 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) |
|
|
| Bendamustine | Drug | 60 mg/m^2 given on the 2nd day of melphalan |
|
|
| Bendamustine | Drug | 90 mg/m^2 given on the 2nd day of melphalan |
|
|
| Bendamustine | Drug | 60 mg/m^2 given on the 1st and 2nd day of melphalan |
|
|
| Bendamustine | Drug | 90 mg/m^2 given on the 1st day of melphalan and 60 mg/m^2 given on the 2nd day of melphalan |
|
|
| Bendamustine | Drug | 125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan |
|
|
| From Day 0 to first incidence of disease progression, up to 1,128 days |
| Progression-Free Survival (Phase 2) | Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of >25% from lowest response value in any one or more of the following:
| From Day 0 to first incidence of disease progression, up to 86 months |
| Overall Survival at 2 Years (Phase 1) | Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years. | From Day 0 until time of death, assessed up to 2 years. |
| Overall Survival at 3 Years (Phase 2) | Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years. | From Day 0 until time of death, assessed up to 3 years. |
| Dose Level 2 |
Dose Level 2; Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 60 mg/m2 given on the 2nd day of melphalan |
| FG002 | Dose Level 3 | Dose Level 3; Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 90 mg/m2 given on the 2nd day of melphalan |
| FG003 | Dose Level 4 | Dose Level 4; Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 60 mg/m2 given on the 1st and 2nd day of melphalan |
| FG004 | Dose Level 5 | Dose Level 5; Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 90 mg/m2 given on the 1st day of melphalan and 60 mg/m2 given on the 2nd day of melphalan |
| FG005 | Dose Level 6 | Dose Level 6; Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan |
| FG006 | Phase 2 | Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 | Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) |
| BG001 | Dose Level 2 | Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) |
| BG002 | Dose Level 3 | Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) |
| BG003 | Dose Level 4 | Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) |
| BG004 | Dose Level 5 | Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) |
| BG005 | Dose Level 6 | Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) |
| BG006 | Phase 2 | Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance <70 ml/min) |
| BG007 | 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Maximum Tolerated Dose (Phase 1) | The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm^3 and platelet count of 20,000/mm^3 untransfused by Day 35 post-transplant. | Phase 1 includes all patients enrolled and treated on Phase 1 of the study (Dose Levels 1 through 6). | Posted | Count of Participants | Participants | 35 days post-transplant |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant | Number of patients achieving at least a partial response or better in disease status at Day 100 post-transplant, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Partial response in disease status is defined by the IMWG as ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours; If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required | Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6. | Posted | Count of Participants | Participants | 100 days post-transplant |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (Phase 1) | Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of >25% from lowest response value in any one or more of the following:
| Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of progression-free survival (PFS), as PFS is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort. | Posted | Median | 95% Confidence Interval | Days | From Day 0 to first incidence of disease progression, up to 1,128 days |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (Phase 2) | Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of >25% from lowest response value in any one or more of the following:
| Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6. | Posted | Median | 95% Confidence Interval | Months | From Day 0 to first incidence of disease progression, up to 86 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 2 Years (Phase 1) | Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years. | Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of overall survival, as overall survival is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort. | Posted | Median | 95% Confidence Interval | Percentage of participants alive | From Day 0 until time of death, assessed up to 2 years. |
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 3 Years (Phase 2) | Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years. | Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6. | Posted | Median | 95% Confidence Interval | Percentage of participants alive | From Day 0 until time of death, assessed up to 3 years. |
|
|
Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
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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 | Dose Level 1 | Dose Level 1; Bendamustine 30 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) Bendamustine: 30 mg/m^2 given on day 2 of melphalan Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) | 2 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Dose Level 2 | Dose Level 2; Bendamustine 60 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 60 mg/m^2 given on the 2nd day of melphalan | 2 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Dose Level 3 | Dose Level 3; Bendamustine 90 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 90 mg/m^2 given on the 2nd day of melphalan | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Dose Level 4 | Dose Level 4; Bendamustine 120 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 60 mg/m^2 given on the 1st and 2nd day of melphalan | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Dose Level 5 | Dose Level 5; Bendamustine 150 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 90 mg/m^2 given on the 1st day of melphalan and 60 mg/m^2 given on the 2nd day of melphalan | 1 | 3 | 0 | 3 | 3 | 3 |
| EG005 | Dose Level 6 | Dose Level 6; Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan | 1 | 7 | 0 | 7 | 7 | 7 |
| EG006 | Phase 2 | Bendamustine 225 mg/m^2 total, Melphalan 200 mg/m^2 total (140 mg/m^2 total for patients with Creatinine Clearance <70 ml/min) Melphalan: 100 mg/m^2 for 2 days (70 mg/m^2 for patients with Creatinine Clearance <70 ml/min) Bendamustine: 125 mg/m^2 given on the 1st day of melphalan and 100mg/m^2 given on the 2nd day of melphalan | 6 | 28 | 8 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral Edema | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Catheter-Related Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Oral Thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline Phopshatase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophospohatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tumor Lysis Syndrome | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Maculopapular Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred Vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Rotavirus Enteritis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Tinea cruris | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Streptococcus mitis Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Tinea pedia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Escherichia coli Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Clostridium difficile Colitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and Infestations - Microsporidia Enteritis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Eye Disorders - Blepharitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Reproductive system and breast disorders - Nipple Sensitivity | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tsiporah Shore | Weill Cornell Medical College | 646-962-7950 | tbs2001@med.cornell.edu |
| 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 |
| D008558 | Melphalan |
| 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 |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| 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 |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|