TriangleNCT01889420 · OUTCOME
Anti-tumor Effect
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- 3.5 years
What was measured
Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement. Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved. Partial response (PR): \>50% reduction in M-protein and \>50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by \>50%. Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: \>25% increase from baseline in serum or urine M-protein (serum M-protein must increase by \> 0.5 gm/dl; urine M-protein must increase by \>200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (\>11.5 mg/dl) attributed to MM.
Analysis population: There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.
Groups in this outcome
Combination Therapy
Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone. Cycles will span 28 days. Dosage schedules will be: 1. Everolimus daily for 28 days of a 28 day cycle; 2. Pomalidomide daily for 21 days of a 28 day cycle 3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.
| Group | Source count |
|---|---|
| Combination Therapy | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement. Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved. Partial response (PR): \>50% reduction in M-protein and \>50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by \>50%. Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: \>25% increase from baseline in serum or urine M-protein (serum M-protein must increase by \> 0.5 gm/dl; urine M-protein must increase by \>200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (\>11.5 mg/dl) attributed to MM.
- groups
- description
- Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone. Cycles will span 28 days. Dosage schedules will be: 1. Everolimus daily for 28 days of a 28 day cycle; 2. Pomalidomide daily for 21 days of a 28 day cycle 3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.
- id
- OG000
- title
- Combination Therapy
- population Description
- There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.
- reporting Status
- POSTED
- time Frame
- 3.5 years
- title
- Anti-tumor Effect
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice