TriangleNCT01745588 · OUTCOME
Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- up to 94 months
What was measured
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Groups in this outcome
Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell
All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion. Pomalidomide stem cell Clarithromycin
Clarithromycin + Pomalidomide + Dexamethasone Alone
All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD. Pomalidomide Dexamethasone Clarithromycin
| Group | Source count |
|---|---|
| Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell | 12 |
| Clarithromycin + Pomalidomide + Dexamethasone Alone | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell | 16 | Not reported | 2 | 94 | Not reported |
| Clarithromycin + Pomalidomide + Dexamethasone Alone | 9 | Not reported | 3 | 88 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 94
- value
- 16
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 88
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 11
- units
- Participants
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- dispersion Type
- Full Range
- groups
- description
- All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion. Pomalidomide stem cell Clarithromycin
- id
- OG000
- title
- Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell
- description
- All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD. Pomalidomide Dexamethasone Clarithromycin
- id
- OG001
- title
- Clarithromycin + Pomalidomide + Dexamethasone Alone
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- up to 94 months
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice