TriangleNCT02375555 · OUTCOME
4 Cycle Ever Dose Modification (DM) Rate
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
- Participants were followed up to 12 weeks.
What was measured
The 4 cycle ever DM rate is the proportion of participants who started therapy and required dose modification of any study drug during the first four cycles of E-RVD.
Analysis population: The analysis dataset is comprised of participants who were dosed (parallel with the safety population).
Groups in this outcome
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
| Group | Source count |
|---|---|
| Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone | .40 | Not reported | .25 | .57 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- .25
- upper Limit
- .57
- value
- .40
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- The 4 cycle ever DM rate is the proportion of participants who started therapy and required dose modification of any study drug during the first four cycles of E-RVD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
- id
- OG000
- title
- Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
- param Type
- NUMBER
- population Description
- The analysis dataset is comprised of participants who were dosed (parallel with the safety population).
- reporting Status
- POSTED
- time Frame
- Participants were followed up to 12 weeks.
- title
- 4 Cycle Ever Dose Modification (DM) Rate
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice