TriangleNCT02168101 · OUTCOME
Median Progression-Free Survival (PFS) at 2 Years Post-maintenance Therapy
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
- every 8 weeks for approximately 24 weeks then every 3 months thereafter for 2 years
What was measured
PFS is measured from the date of first protocol treatment until date of disease progression or death occurs, or date of last adequate tumor assessment using the International Myeloma Working Group Uniform Response Criteria. IMWG disease progression is defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: 1) serum M-protein, 2) urine M-protein, 3) only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels, 4) Bone marrow plasma cell percentage (absolute % must be ≥10%). OR Disease progression also could include development of new lytic bone lesions or increase from baseline in size of lytic bone lesion(s); development of new soft tissue plasmacytoma(s) or definite increase from nadir in existing soft tissue plasmacytomas; or development of hypercalcemia
Analysis population: All patients with measurable or evaluable disease at baseline who receive at least 1 dose of MLN9708 and undergo at least one post-baseline disease assessment. Pre-specified in Protocol to calculate PFS for all participants and for all patients receiving the MTD. Because the MTD was not reached, this analysis was only performed on all participants.
Groups in this outcome
MLN9708 Combined Dose Escalation
Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of either 2.3, 3, or 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
| Group | Source count |
|---|---|
| MLN9708 Combined Dose Escalation | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MLN9708 Combined Dose Escalation | 6.5 | Not reported | 1.9 | 21.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 21.7
- value
- 6.5
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- PFS is measured from the date of first protocol treatment until date of disease progression or death occurs, or date of last adequate tumor assessment using the International Myeloma Working Group Uniform Response Criteria. IMWG disease progression is defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: 1) serum M-protein, 2) urine M-protein, 3) only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels, 4) Bone marrow plasma cell percentage (absolute % must be ≥10%). OR Disease progression also could include development of new lytic bone lesions or increase from baseline in size of lytic bone lesion(s); development of new soft tissue plasmacytoma(s) or definite increase from nadir in existing soft tissue plasmacytomas; or development of hypercalcemia
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of either 2.3, 3, or 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
- id
- OG000
- title
- MLN9708 Combined Dose Escalation
- param Type
- MEDIAN
- population Description
- All patients with measurable or evaluable disease at baseline who receive at least 1 dose of MLN9708 and undergo at least one post-baseline disease assessment. Pre-specified in Protocol to calculate PFS for all participants and for all patients receiving the MTD. Because the MTD was not reached, this analysis was only performed on all participants.
- reporting Status
- POSTED
- time Frame
- every 8 weeks for approximately 24 weeks then every 3 months thereafter for 2 years
- title
- Median Progression-Free Survival (PFS) at 2 Years Post-maintenance Therapy
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice