TriangleNCT02880228 · OUTCOME
Proportion of Complete Response Plus Very Good Partial Response (VGPR)
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 International Myeloma Working Group response criteria was used to assess response to therapy. The proportion of VGPR response at any time during treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients achieving a VGPR, CR, or sCR at any time divided by the total number of evaluable patients. A very good partial response (VGPR) is defined as as a demonstration of: * Serum and urine M-component detectable by immunofixation but not on electrophoresis c or * greater than 90% reduction in serum m-component and urine m-component \<100 mg/24 h * If the only measurable disease is FLC, a ≥90% reduction in the difference between involved and involved FLC levels The proportion of successes will be estimated by the number of patients demonstrating a VGPR or better divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
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) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | 0 | Not reported | 0 | 0.28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0.28
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- The International Myeloma Working Group response criteria was used to assess response to therapy. The proportion of VGPR response at any time during treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients achieving a VGPR, CR, or sCR at any time divided by the total number of evaluable patients. A very good partial response (VGPR) is defined as as a demonstration of: * Serum and urine M-component detectable by immunofixation but not on electrophoresis c or * greater than 90% reduction in serum m-component and urine m-component \<100 mg/24 h * If the only measurable disease is FLC, a ≥90% reduction in the difference between involved and involved FLC levels The proportion of successes will be estimated by the number of patients demonstrating a VGPR or better divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
- 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
- reporting Status
- POSTED
- time Frame
- Up to 112 days
- title
- Proportion of Complete Response Plus Very Good Partial Response (VGPR)
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice