TriangleNCT02441686 · OUTCOME
4-Cycle Induction Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Participants were followed up to 12 weeks.
What was measured
4-cycle ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during the first 4 cycles of induction therapy.
Analysis population: Evaluable for disease response analysis having started therapy and assessed for disease post-baseline.
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 | 95 | Not reported | 85 | 99 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85
- upper Limit
- 99
- value
- 95
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- 4-cycle ORR was defined as the percentage of participants who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during the first 4 cycles of induction therapy.
- dispersion Type
- 90% 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
- NUMBER
- population Description
- Evaluable for disease response analysis having started therapy and assessed for disease post-baseline.
- reporting Status
- POSTED
- time Frame
- Participants were followed up to 12 weeks.
- title
- 4-Cycle Induction Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice