NCT01842308 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 35
- group Id
- BG005
- value
- 49
- units
- Participants
- groups
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG000
- title
- Phase 1; Dose Level 3
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG001
- title
- Phase 1; Dose Level 2
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG002
- title
- Phase 1; Dose Level 1
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG003
- title
- Phase 1; Dose Level 0
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG004
- title
- Phase 2
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 65
- value
- 52
- group Id
- BG001
- lower Limit
- 44
- upper Limit
- 63
- value
- 61
- group Id
- BG002
- lower Limit
- 60
- upper Limit
- 66
- value
- 61
- group Id
- BG003
- lower Limit
- 50
- upper Limit
- 60
- value
- 55
- group Id
- BG004
- lower Limit
- 46
- upper Limit
- 77
- value
- 61
- group Id
- BG005
- lower Limit
- 42
- upper Limit
- 77
- value
- 60
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 14
- group Id
- BG005
- value
- 17
- title
- Female
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 21
- group Id
- BG005
- value
- 32
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 32
- group Id
- BG005
- value
- 45
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All patients that began treatment
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 35
- group Id
- BG005
- value
- 49
- units
- Participants
- groups
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG000
- title
- Phase 1; Dose Level 3
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG001
- title
- Phase 1; Dose Level 2
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG002
- title
- Phase 1; Dose Level 1
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG003
- title
- Phase 1; Dose Level 0
- description
- CONDITIONING: Patients receive carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
- id
- BG004
- title
- Phase 2
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 65
- value
- 52
- group Id
- BG001
- lower Limit
- 44
- upper Limit
- 63
- value
- 61
- group Id
- BG002
- lower Limit
- 60
- upper Limit
- 66
- value
- 61
- group Id
- BG003
- lower Limit
- 50
- upper Limit
- 60
- value
- 55
- group Id
- BG004
- lower Limit
- 46
- upper Limit
- 77
- value
- 61
- group Id
- BG005
- lower Limit
- 42
- upper Limit
- 77
- value
- 60
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 14
- group Id
- BG005
- value
- 17
- title
- Female
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 21
- group Id
- BG005
- value
- 32
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 32
- group Id
- BG005
- value
- 45
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All patients that began treatment
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Preserved source evidence · Not medical advice
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