TriangleNCT02441686 · OUTCOME
Median Duration of Response (DOR)
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
- Disease was assessed up to 41.2 months.
What was measured
DOR was defined at the time from the first assessment indicating PR or better response to the first progression (PD) event based on IMWG criteria.
Analysis population: The analysis population is comprised of participants who achieved partial response.
Groups in this outcome
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
| Group | Source count |
|---|---|
| Lenalidomide, Subcutaneous Bortezomib, Dexamethasone | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide, Subcutaneous Bortezomib, Dexamethasone | NA | Not reported | 24.2 | NA | The data are not mature because follow-up for events is not long enough. As such, the median was not reached and the upper bound 95% CI could not be estimated. |
Complete source fields
- classes
- categories
- measurements
- comment
- The data are not mature because follow-up for events is not long enough. As such, the median was not reached and the upper bound 95% CI could not be estimated.
- group Id
- OG000
- lower Limit
- 24.2
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- DOR was defined at the time from the first assessment indicating PR or better response to the first progression (PD) event based on IMWG criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
- id
- OG000
- title
- Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
- param Type
- MEDIAN
- population Description
- The analysis population is comprised of participants who achieved partial response.
- reporting Status
- POSTED
- time Frame
- Disease was assessed up to 41.2 months.
- title
- Median Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice