TriangleNCT03201965 · OUTCOME
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
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
- From date of first randomization (Day -3) upto 6.5 years
What was measured
MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first. Per international amyloidosis consensus criteria (IACC), hematologic progression was defined as satisfying any one of the following criteria: 1) From CHR, abnormal free light chain ratio (light chain must be double and \>ULN); 2) From CHR/VGPR/PR, 50 percent (%) increase in serum M-protein to \>0.5 grams per deciliter (g/dL) or 50% increase in urine M-protein to 200 milligrams (mg)/day; 3) free light chain increase of 50% to 100 milligrams (mg)/Liter (L).
Analysis population: The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Groups in this outcome
CyBorD
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
Daratumumab Plus CyBorD
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
| Group | Source count |
|---|---|
| CyBorD | 193 |
| Daratumumab Plus CyBorD | 195 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CyBorD | 30.23 | Not reported | 16.66 | 48.89 | Not reported |
| Daratumumab Plus CyBorD | NA | Not reported | NA | NA | Here, 'NA' signifies that Median, lower limit and upper limit of 95% confidence interval (CI) could not be estimated due to an insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.66
- upper Limit
- 48.89
- value
- 30.23
- comment
- Here, 'NA' signifies that Median, lower limit and upper limit of 95% confidence interval (CI) could not be estimated due to an insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 193
- group Id
- OG001
- value
- 195
- units
- Participants
- description
- MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first. Per international amyloidosis consensus criteria (IACC), hematologic progression was defined as satisfying any one of the following criteria: 1) From CHR, abnormal free light chain ratio (light chain must be double and \>ULN); 2) From CHR/VGPR/PR, 50 percent (%) increase in serum M-protein to \>0.5 grams per deciliter (g/dL) or 50% increase in urine M-protein to 200 milligrams (mg)/day; 3) free light chain increase of 50% to 100 milligrams (mg)/Liter (L).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
- id
- OG000
- title
- CyBorD
- description
- Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
- id
- OG001
- title
- Daratumumab Plus CyBorD
- param Type
- MEDIAN
- population Description
- The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
- reporting Status
- POSTED
- time Frame
- From date of first randomization (Day -3) upto 6.5 years
- title
- Major Organ Deterioration Progression-Free Survival (MOD-PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice