TriangleNCT03180736 · OUTCOME
Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years).
What was measured
Progression Free Survival (PFS) is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first. PFS2 is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first, after the next line of therapy. PD is assessed by the investigator based on the analysis of serum and urine protein electrophoresis (sPEP and uPEP), serum and urine immunofixation (sIFE and uIFE), serum free light chain protein (sFLC),corrected serum calcium assessment, imaging and bone marrow assessments as per modified IMWG guidelines.
Analysis population: The intent-to-treat (ITT) analysis set includes all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.
Groups in this outcome
Daratumumab+Pomalidomide+Dexamethasone
Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
Pomalidomide + Dexamethasone
Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
| Group | Source count |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 151 |
| Pomalidomide + Dexamethasone | 153 |
Reported measurements
PFS2
| Group | Source count |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 88 |
| Pomalidomide + Dexamethasone | 105 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 24.41 | Not reported | 17.05 | 35.71 | Not reported |
| Pomalidomide + Dexamethasone | 17.58 | Not reported | 13.57 | 21.98 | Not reported |
Primary Efficacy of PFS
| Group | Source count |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 151 |
| Pomalidomide + Dexamethasone | 153 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 12.42 | Not reported | 8.34 | 19.32 | Not reported |
| Pomalidomide + Dexamethasone | 6.93 | Not reported | 5.52 | 9.26 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.05
- upper Limit
- 35.71
- value
- 24.41
- group Id
- OG001
- lower Limit
- 13.57
- upper Limit
- 21.98
- value
- 17.58
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 105
- units
- Participants
- title
- PFS2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.34
- upper Limit
- 19.32
- value
- 12.42
- group Id
- OG001
- lower Limit
- 5.52
- upper Limit
- 9.26
- value
- 6.93
- denoms
- counts
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 153
- units
- Participants
- title
- Primary Efficacy of PFS
- denoms
- counts
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- Progression Free Survival (PFS) is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first. PFS2 is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first, after the next line of therapy. PD is assessed by the investigator based on the analysis of serum and urine protein electrophoresis (sPEP and uPEP), serum and urine immunofixation (sIFE and uIFE), serum free light chain protein (sFLC),corrected serum calcium assessment, imaging and bone marrow assessments as per modified IMWG guidelines.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG000
- title
- Daratumumab+Pomalidomide+Dexamethasone
- description
- Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
- id
- OG001
- title
- Pomalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- The intent-to-treat (ITT) analysis set includes all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.
- reporting Status
- POSTED
- time Frame
- PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years).
- title
- Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice