NCT02880228 · OUTCOME
Progression-free Survival
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
- From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
What was measured
Progression-free survival is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients who receive subsequent treatment for myeloma before disease progression will be censored on the date of their last disease assessment prior to initiation of the subsequent treatment. Transplant will not be considered subsequent treatment. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Analysis population: All patients that began protocol treatment were included in this analysis.
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) | NA | Not reported | NA | NA | Too few events occurred to estimate the median and confidence interval. |
Complete source fields
- classes
- categories
- measurements
- comment
- Too few events occurred to estimate the median and confidence interval.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- Progression-free survival is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients who receive subsequent treatment for myeloma before disease progression will be censored on the date of their last disease assessment prior to initiation of the subsequent treatment. Transplant will not be considered subsequent treatment. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
- 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
- MEDIAN
- population Description
- All patients that began protocol treatment were included in this analysis.
- reporting Status
- POSTED
- time Frame
- From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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