TriangleNCT01208662 · OUTCOME
5-Year Time to Progression (TTP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median TTP follow-up was 70 months. The probability estimate is at 5 years.
What was measured
TTP was estimated using the KM method and defined as time from randomization to time of documented IMWG disease progression or censoring time (time of last disease evaluation for those alive, time to death among those who died). Patients initiating non-protocol therapy prior to progression or death were censored at the date of non-protocol therapy in the TTP analysis. The 5-year TTP endpoint is a probability.
Analysis population: The analysis population is comprised of all randomized participants.
Groups in this outcome
RVD Alone
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
RVD Plus ASCT
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
| Group | Source count |
|---|---|
| RVD Alone | 357 |
| RVD Plus ASCT | 365 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RVD Alone | 41.6 | Not reported | 35.8 | 47.3 | Not reported |
| RVD Plus ASCT | 58.4 | Not reported | 52.2 | 64.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.29
- ci Upper Limit
- 2.27
- group Description
- Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 1.66
- statistical Comment
- Stratified
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.29
- ci Upper Limit
- 2.27
- group Description
- Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 1.66
- statistical Comment
- Stratified
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.8
- upper Limit
- 47.3
- value
- 41.6
- group Id
- OG001
- lower Limit
- 52.2
- upper Limit
- 64.2
- value
- 58.4
- denoms
- counts
- group Id
- OG000
- value
- 357
- group Id
- OG001
- value
- 365
- units
- Participants
- description
- TTP was estimated using the KM method and defined as time from randomization to time of documented IMWG disease progression or censoring time (time of last disease evaluation for those alive, time to death among those who died). Patients initiating non-protocol therapy prior to progression or death were censored at the date of non-protocol therapy in the TTP analysis. The 5-year TTP endpoint is a probability.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
- id
- OG000
- title
- RVD Alone
- description
- All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
- id
- OG001
- title
- RVD Plus ASCT
- param Type
- NUMBER
- population Description
- The analysis population is comprised of all randomized participants.
- reporting Status
- POSTED
- time Frame
- On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median TTP follow-up was 70 months. The probability estimate is at 5 years.
- title
- 5-Year Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- percent probability
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Preserved source evidence · Not medical advice