NCT03622775 · OUTCOME
Number of Participants With Complete Remission
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
- Within 9 months post salvage auto transplant
What was measured
Number of participants that achieved Complete remission (CR) 9 months post auto transplant. Complete remission (CR) (all of the following): 1. Negative immunofixation in serum and urine. 2. \< 5% plasma cells in the bone marrow. 3. Disappearance of any soft tissue plasmacytomas.
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
Source class 1
| 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 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- Number of participants that achieved Complete remission (CR) 9 months post auto transplant. Complete remission (CR) (all of the following): 1. Negative immunofixation in serum and urine. 2. \< 5% plasma cells in the bone marrow. 3. Disappearance of any soft tissue plasmacytomas.
- 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
- Within 9 months post salvage auto transplant
- title
- Number of Participants With Complete Remission
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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