TriangleNCT01953692 · OUTCOME
Duration of Response (DOR) 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
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 78.5 months
What was measured
For participants who demonstrated a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), DOR was defined as the time from sCR, CR, VGPR, or PR to documented disease progression or death. Response was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p \<100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to \<200 mg/24 hours. DOR as assessed by the investigator is presented.
Analysis population: All participants in Cohort 2 with a baseline efficacy evaluation, at least 1 post-baseline efficacy evaluation, and who demonstrated a VGPR, PR, sCR, or CR. DOR was not analyzed because there were no participants who demonstrated a VGPR, PR, sCR, or CR in Cohort 2.
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) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- For participants who demonstrated a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), DOR was defined as the time from sCR, CR, VGPR, or PR to documented disease progression or death. Response was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p \<100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to \<200 mg/24 hours. DOR as assessed by the investigator is presented.
- 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)
- population Description
- All participants in Cohort 2 with a baseline efficacy evaluation, at least 1 post-baseline efficacy evaluation, and who demonstrated a VGPR, PR, sCR, or CR. DOR was not analyzed because there were no participants who demonstrated a VGPR, PR, sCR, or CR in Cohort 2.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Duration of Response (DOR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice