TriangleNCT02252172 · OUTCOME
Sub-group Analysis: 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
- 95% Confidence Interval
- Time frame
- From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 6.6 years).
What was measured
PFS for participants with cytogenic high risk was reported. PFS was time from date of randomization to either PD or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD: an increase of 25% from lowest response value in one of following: serum and urine M-component (absolute increase must be \>=0.5 g/dL and \>=200 mg/24h respectively); Only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute \>10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to PC proliferative disorder. High risk was defined as positive for any of del17p, t(14;16) or t(4;14) by (corrected serum calcium \>11.5 mg/dL) Fluorescence In Situ Hybridization (FISH)/Karyotype.
Analysis population: Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure.
Groups in this outcome
Lenalidomide + Dexamethasone (Rd)
Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).
Daratumumab + Lenalidomide + Dexamethasone (DRd)
Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
| Group | Source count |
|---|---|
| Lenalidomide + Dexamethasone (Rd) | 31 |
| Daratumumab + Lenalidomide + Dexamethasone (DRd) | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide + Dexamethasone (Rd) | 29.6 | Not reported | 15.6 | 34.5 | Not reported |
| Daratumumab + Lenalidomide + Dexamethasone (DRd) | 45.3 | Not reported | 18.4 | 61.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.6
- upper Limit
- 34.5
- value
- 29.6
- group Id
- OG001
- lower Limit
- 18.4
- upper Limit
- 61.9
- value
- 45.3
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- PFS for participants with cytogenic high risk was reported. PFS was time from date of randomization to either PD or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD: an increase of 25% from lowest response value in one of following: serum and urine M-component (absolute increase must be \>=0.5 g/dL and \>=200 mg/24h respectively); Only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute \>10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to PC proliferative disorder. High risk was defined as positive for any of del17p, t(14;16) or t(4;14) by (corrected serum calcium \>11.5 mg/dL) Fluorescence In Situ Hybridization (FISH)/Karyotype.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).
- id
- OG000
- title
- Lenalidomide + Dexamethasone (Rd)
- description
- Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
- id
- OG001
- title
- Daratumumab + Lenalidomide + Dexamethasone (DRd)
- param Type
- MEDIAN
- population Description
- Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 6.6 years).
- title
- Sub-group Analysis: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice