TriangleNCT01953692 · OUTCOME
Progression-free Survival (PFS) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
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 approximately 78.5 months
What was measured
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. PD was defined as ≥1 of the following: increase of ≥25% from baseline of serum or urine M-component or \>10 mg/dl difference between involved and uninvolved free light chain levels; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; or hypercalcemia. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
Analysis population: All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Groups in this outcome
Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
| Group | Source count |
|---|---|
| Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) | 2.7 | Not reported | 1.4 | 13.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 13.0
- value
- 2.7
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. PD was defined as ≥1 of the following: increase of ≥25% from baseline of serum or urine M-component or \>10 mg/dl difference between involved and uninvolved free light chain levels; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; or hypercalcemia. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
- param Type
- MEDIAN
- population Description
- All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Progression-free Survival (PFS) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice