TriangleNCT02043847 · OUTCOME
Progression Free Survival (PFS) and in Patients With Multiple Myeloma (Relapsed or Refractory) Undergoing Autologous Stem Cell Transplant Using the Combination of High Dose Melphalan and Total Marrow Irradiation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 1 year post-transplant.
What was measured
The disease status of enrolled patients will be evaluated based on the International Myeloma Working Group Criteria. Response Criteria Stringent Complete Response (sCR) in addition to CR all of the following: 1. Normal free light chain ratio (FLC) 2. Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed Complete Response (CR) requires all of the following: 1. Absence of the original monoclonal paraprotein in the serum or the urine by routine electrophoresis and by immunofixation. The presence of new monoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. 2. Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed. 3. No increase in size or number of lytic bone lesions on radiologic investigation (development of compression fracture does not exclude CR and radiographs are not required to document CR if not clinically indicated) 4. Disappearance of soft tissue plasmacytoma
Analysis population: There was no MTD reached for any Cohort
Groups in this outcome
Cohort 1Total Marrow Irradiation (TMI) 3Gy
3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
| Group | Source count |
|---|---|
| Cohort 1Total Marrow Irradiation (TMI) 3Gy | 3 |
| Cohort 2 Total Marrow Irradiation (TMI) 6Gy | 3 |
| Cohort 3 Total Marrow Irradiation (TMI) 9Gy | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1Total Marrow Irradiation (TMI) 3Gy | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Total Marrow Irradiation (TMI) 6Gy | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 Total Marrow Irradiation (TMI) 9Gy | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- The disease status of enrolled patients will be evaluated based on the International Myeloma Working Group Criteria. Response Criteria Stringent Complete Response (sCR) in addition to CR all of the following: 1. Normal free light chain ratio (FLC) 2. Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed Complete Response (CR) requires all of the following: 1. Absence of the original monoclonal paraprotein in the serum or the urine by routine electrophoresis and by immunofixation. The presence of new monoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. 2. Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed. 3. No increase in size or number of lytic bone lesions on radiologic investigation (development of compression fracture does not exclude CR and radiographs are not required to document CR if not clinically indicated) 4. Disappearance of soft tissue plasmacytoma
- groups
- description
- 3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
- id
- OG000
- title
- Cohort 1Total Marrow Irradiation (TMI) 3Gy
- description
- 6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
- id
- OG001
- title
- Cohort 2 Total Marrow Irradiation (TMI) 6Gy
- description
- 9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
- id
- OG002
- title
- Cohort 3 Total Marrow Irradiation (TMI) 9Gy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- There was no MTD reached for any Cohort
- reporting Status
- POSTED
- time Frame
- Up to 1 year post-transplant.
- title
- Progression Free Survival (PFS) and in Patients With Multiple Myeloma (Relapsed or Refractory) Undergoing Autologous Stem Cell Transplant Using the Combination of High Dose Melphalan and Total Marrow Irradiation
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice