NCT03713294 · OUTCOME
Percentage of Patients Achieving CR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients who achieve CR
- Interval / dispersion
- Not reported
- Time frame
- 3 years
What was measured
Will be estimated by the number of patients who achieve a sCR or CR divided by the total number of evaluable patients. Complete Response (CR) is defined by all of the following: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma; \<5% PCs in bone marrow; and if the only measurable disease is Free Light Chain (FLC), a normal FLC ratio. Stringent Complete Response (sCR) is defined as CR plus normal FLC ratio and absence of clonal circulating plasma cells (PCs) immunohistochemistry or 2- to 4- color flow cytometry.
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 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 37
- units
- Participants
- description
- Will be estimated by the number of patients who achieve a sCR or CR divided by the total number of evaluable patients. Complete Response (CR) is defined by all of the following: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma; \<5% PCs in bone marrow; and if the only measurable disease is Free Light Chain (FLC), a normal FLC ratio. Stringent Complete Response (sCR) is defined as CR plus normal FLC ratio and absence of clonal circulating plasma cells (PCs) immunohistochemistry or 2- to 4- color flow cytometry.
- 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
- Percentage of Patients Achieving CR
- type
- SECONDARY
- unit Of Measure
- percentage of patients who achieve CR
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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