TriangleNCT02316106 · OUTCOME
Progression Free Survival (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
- 90% Confidence Interval
- Time frame
- From randomization (Day -5) until disease progression or death whichever occurred first (up to 7.89 years)
What was measured
PFS: time from dates of randomization to initial documented PD per Sixty percent, bone marrow plasma cells (BMPC), Light chains, focal lesions per MRI, elevated Calcium, Renal failure, Anemia, Bone lesions (SLiM-CRAB) criteria, or date of death, whichever was first. SLiM-CRAB criteria: clonal BM PCs percentage (%): \>=60%, Involved: uninvolved serum free LC ratio \>=100, \>1 focal lesion on MRI studies, calcium:\>0.25 millimole/liter (mmol/L)(\>1 mg/dL) higher than upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); creatinine clearance \<40 mL/min or serum creatinine \>177 micromole/liter (\>2 mg/dL); hemoglobin \<10 g/dL(\<6.5 mmol/L) or \>2 g/dL(\>1.25 mmol/L) lower than lower limit of normal;\>1 osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT). Kaplan-Meier estimate was used.
Analysis population: ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Groups in this outcome
Arm A (Long Intense)
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
Arm B (Intermediate)
Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
Arm C (Short Intense)
Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).
| Group | Source count |
|---|---|
| Arm A (Long Intense) | 20 |
| Arm B (Intermediate) | 18 |
| Arm C (Short Intense) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Long Intense) | 81.12 | Not reported | 58.02 | NA | Here, 'NA' signifies upper limit of 90% CI were not estimable due to low number of participants with events. |
| Arm B (Intermediate) | 84.44 | Not reported | 44.02 | NA | Here, 'NA' signifies upper limit of 90% CI were not estimable due to low number of participants with events. |
| Arm C (Short Intense) | 81.35 | Not reported | 51.45 | NA | Here, 'NA' signifies upper limit of 90% CI were not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here, 'NA' signifies upper limit of 90% CI were not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 58.02
- upper Limit
- NA
- value
- 81.12
- comment
- Here, 'NA' signifies upper limit of 90% CI were not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 44.02
- upper Limit
- NA
- value
- 84.44
- comment
- Here, 'NA' signifies upper limit of 90% CI were not estimable due to low number of participants with events.
- group Id
- OG002
- lower Limit
- 51.45
- upper Limit
- NA
- value
- 81.35
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 16
- units
- Participants
- description
- PFS: time from dates of randomization to initial documented PD per Sixty percent, bone marrow plasma cells (BMPC), Light chains, focal lesions per MRI, elevated Calcium, Renal failure, Anemia, Bone lesions (SLiM-CRAB) criteria, or date of death, whichever was first. SLiM-CRAB criteria: clonal BM PCs percentage (%): \>=60%, Involved: uninvolved serum free LC ratio \>=100, \>1 focal lesion on MRI studies, calcium:\>0.25 millimole/liter (mmol/L)(\>1 mg/dL) higher than upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); creatinine clearance \<40 mL/min or serum creatinine \>177 micromole/liter (\>2 mg/dL); hemoglobin \<10 g/dL(\<6.5 mmol/L) or \>2 g/dL(\>1.25 mmol/L) lower than lower limit of normal;\>1 osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT). Kaplan-Meier estimate was used.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
- id
- OG000
- title
- Arm A (Long Intense)
- description
- Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).
- id
- OG001
- title
- Arm B (Intermediate)
- description
- Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).
- id
- OG002
- title
- Arm C (Short Intense)
- param Type
- MEDIAN
- population Description
- ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From randomization (Day -5) until disease progression or death whichever occurred first (up to 7.89 years)
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice