TriangleNCT03622775 · OUTCOME
Number of Participants That Relapsed With Progression-free Survival (PFS)
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
- From the date of initiation of maintenance therapy assessed up to 5 years
What was measured
Progression-free survival is defined as the interval from the date of initiation of maintenance therapy after salvage ASCT to the earlier of the first documentation of objective disease progression or death from any cause.
Groups in this outcome
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide. Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression. Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
| Group | Source count |
|---|---|
| Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. | 13 |
Reported measurements
PFS at 20 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. | 11 | Not reported | Not reported | Not reported | Not reported |
PFS at 36 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. | 8 | Not reported | Not reported | Not reported | Not reported |
PFS at 60 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- title
- PFS at 20 months
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- PFS at 36 months
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- PFS at 60 months
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- Progression-free survival is defined as the interval from the date of initiation of maintenance therapy after salvage ASCT to the earlier of the first documentation of objective disease progression or death from any cause.
- groups
- description
- Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide. Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression. Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
- id
- OG000
- title
- Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From the date of initiation of maintenance therapy assessed up to 5 years
- title
- Number of Participants That Relapsed With Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice