NCT03030261 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 1 year
What was measured
-Overall response rate (ORR) will be defined as the proportion of evaluable patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).
Analysis population: Only 18 patients were evaluable for this outcome measure. 6 patients did not have ASCT and 1 patient had ASCT but did not start continuation treatment.
Groups in this outcome
Elotuzumab + Pomalidomide + Dexamethasone
* Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study. * Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol. * Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression.
| Group | Source count |
|---|---|
| Elotuzumab + Pomalidomide + Dexamethasone | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab + Pomalidomide + Dexamethasone | 18 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 18
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- -Overall response rate (ORR) will be defined as the proportion of evaluable patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).
- groups
- description
- * Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study. * Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol. * Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression.
- id
- OG000
- title
- Elotuzumab + Pomalidomide + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Only 18 patients were evaluable for this outcome measure. 6 patients did not have ASCT and 1 patient had ASCT but did not start continuation treatment.
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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