TriangleNCT02880228 · OUTCOME
Partial Response (PR)
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
- 95% Confidence Interval
- Time frame
- Up to 112 days
What was measured
The PR response after 4 cycles of induction treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients who achieve a PR, VGPR, CR, or sCR after 4 cycles divided by the total number of evaluable patients. A PR is defined by the following criteria:\> * If present at baseline, ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to \<200 mg/24hrs\> * If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and involved FLC levels\> * If the only measurable disease is BM, a ≥50% reduction in BM PC's (provided the baseline PC's was ≥30%)\> * If present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas\> Exact binomial 95% confidence intervals for the true success rate will be calculated.
Analysis population: Only patients that completed 4 cycles of treatment were included in this endpoint.
Groups in this outcome
Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
| Group | Source count |
|---|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | 0 | Not reported | 0 | 0.52 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0.52
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- The PR response after 4 cycles of induction treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients who achieve a PR, VGPR, CR, or sCR after 4 cycles divided by the total number of evaluable patients. A PR is defined by the following criteria:\> * If present at baseline, ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to \<200 mg/24hrs\> * If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and involved FLC levels\> * If the only measurable disease is BM, a ≥50% reduction in BM PC's (provided the baseline PC's was ≥30%)\> * If present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas\> Exact binomial 95% confidence intervals for the true success rate will be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
- id
- OG000
- title
- Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
- param Type
- NUMBER
- population Description
- Only patients that completed 4 cycles of treatment were included in this endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 112 days
- title
- Partial Response (PR)
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice