TriangleNCT03713294 · OUTCOME
Overall Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- Not reported
- Time frame
- 3 years
What was measured
Overall response rate (ORR) defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR). CR and sCR are defined in Outcome 2. VGPR requires: serum and urine M-protein detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-protein and urine M-protein \<100 mg/24 h. If the only measurable disease is FLC, a \>90% reduction in the difference between involved and uninvolved FLC levels. PR requires: if present at baseline, \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \<200 mg/24hrs. If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and uninvolved FLC levels. If the only measurable disease is BM, a ≥ 50% reduction in BM PCs (provided the baseline PCs was ≥ 30%). If present at baseline, ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas.
Groups in this outcome
Treatment
Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Treatment | 37 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment | 0.35 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.35
- denoms
- counts
- group Id
- OG000
- value
- 37
- units
- Participants
- description
- Overall response rate (ORR) defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR). CR and sCR are defined in Outcome 2. VGPR requires: serum and urine M-protein detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-protein and urine M-protein \<100 mg/24 h. If the only measurable disease is FLC, a \>90% reduction in the difference between involved and uninvolved FLC levels. PR requires: if present at baseline, \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \<200 mg/24hrs. If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and uninvolved FLC levels. If the only measurable disease is BM, a ≥ 50% reduction in BM PCs (provided the baseline PCs was ≥ 30%). If present at baseline, ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas.
- groups
- description
- Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Treatment
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice