NCT03417284 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG000
- title
- Group1_Dose 1 200mgm2
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG001
- title
- Group 1_Dose 2 225mgm2
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG002
- title
- Group 2_Dose 1 200mgm2
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG003
- title
- Group 2_Dose 225mgm2
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Inadequate supply on study drug
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 27
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 27
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 27
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- All participants were registered in MD Anderson Cancer Center.
Complete source fields
- groups
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG000
- title
- Group1_Dose 1 200mgm2
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG001
- title
- Group 1_Dose 2 225mgm2
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG002
- title
- Group 2_Dose 1 200mgm2
- description
- PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
- id
- FG003
- title
- Group 2_Dose 225mgm2
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Inadequate supply on study drug
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 27
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 27
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 27
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 27
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- All participants were registered in MD Anderson Cancer Center.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle