TriangleNCT01045460 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years
What was measured
Median number of months that participants were alive without disease relapse or progression (progression-free survival).
Analysis population: Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.
Groups in this outcome
ASCT + MILs
Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0.
ASCT + MILs + Vaccine
Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2
| Group | Source count |
|---|---|
| ASCT + MILs | 14 |
| ASCT + MILs + Vaccine | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ASCT + MILs | 15.5 | Not reported | 13 | 37 | Not reported |
| ASCT + MILs + Vaccine | 18.6 | Not reported | 13 | 27 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13
- upper Limit
- 37
- value
- 15.5
- group Id
- OG001
- lower Limit
- 13
- upper Limit
- 27
- value
- 18.6
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- Median number of months that participants were alive without disease relapse or progression (progression-free survival).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0.
- id
- OG000
- title
- ASCT + MILs
- description
- Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2
- id
- OG001
- title
- ASCT + MILs + Vaccine
- param Type
- MEDIAN
- population Description
- Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice