TriangleNCT02874742 · OUTCOME
Percentage of Participants With Negative Minimal Residual Disease (MRD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to end of following: induction treatment, post-ASCT consolidation (after Cycle 6) (up to 4.5 months), and at the end of maintenance period of 24 months (overall duration up to 34 months)
What was measured
Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. Minimal residual disease was evaluated in participants who achieved CR or sCR (including participants with VGPR or better and suspected daratumumab interference) using next-generation sequencing which utilizes multiple myeloma cell DNA from bone marrow aspirates at a threshold of less than (\<) 10\^5.
Analysis population: Intent to treat (ITT) analysis set which included all randomized participants.
Groups in this outcome
Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)
Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy \[HDT\] and autologous stem cell transplantation \[ASCT\]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week \[until disease progression/up to maximum of 2 years\])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
Randomized: Daratumumab+RVd (D-RVd)
Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator.
Safety Run-in: D-RVd
Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
| Group | Source count |
|---|---|
| Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd) | 103 |
| Randomized: Daratumumab+RVd (D-RVd) | 104 |
| Safety Run-in: D-RVd | 16 |
Reported measurements
MRD from randomization to prior to ASCT (10^5)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd) | 7.8 | Not reported | 3.4 | 14.7 | Not reported |
| Randomized: Daratumumab+RVd (D-RVd) | 22.1 | Not reported | 14.6 | 31.3 | Not reported |
| Safety Run-in: D-RVd | 18.8 | Not reported | 4.0 | 45.6 | Not reported |
Post ASCT consolidation (10^5)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd) | 20.4 | Not reported | 13.1 | 29.5 | Not reported |
| Randomized: Daratumumab+RVd (D-RVd) | 50.0 | Not reported | 40.0 | 60.0 | Not reported |
| Safety Run-in: D-RVd | 50.0 | Not reported | 24.7 | 75.3 | Not reported |
At the End of Maintenance Period (up to 24 Months) (10^5)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd) | 30.1 | Not reported | 21.5 | 39.9 | Not reported |
| Randomized: Daratumumab+RVd (D-RVd) | 64.4 | Not reported | 54.4 | 73.6 | Not reported |
| Safety Run-in: D-RVd | 81.3 | Not reported | 54.4 | 96.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.4
- upper Limit
- 14.7
- value
- 7.8
- group Id
- OG001
- lower Limit
- 14.6
- upper Limit
- 31.3
- value
- 22.1
- group Id
- OG002
- lower Limit
- 4.0
- upper Limit
- 45.6
- value
- 18.8
- title
- MRD from randomization to prior to ASCT (10^5)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.1
- upper Limit
- 29.5
- value
- 20.4
- group Id
- OG001
- lower Limit
- 40.0
- upper Limit
- 60.0
- value
- 50.0
- group Id
- OG002
- lower Limit
- 24.7
- upper Limit
- 75.3
- value
- 50.0
- title
- Post ASCT consolidation (10^5)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.5
- upper Limit
- 39.9
- value
- 30.1
- group Id
- OG001
- lower Limit
- 54.4
- upper Limit
- 73.6
- value
- 64.4
- group Id
- OG002
- lower Limit
- 54.4
- upper Limit
- 96.0
- value
- 81.3
- title
- At the End of Maintenance Period (up to 24 Months) (10^5)
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 104
- group Id
- OG002
- value
- 16
- units
- Participants
- description
- Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. Minimal residual disease was evaluated in participants who achieved CR or sCR (including participants with VGPR or better and suspected daratumumab interference) using next-generation sequencing which utilizes multiple myeloma cell DNA from bone marrow aspirates at a threshold of less than (\<) 10\^5.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Induction and Consolidation Phase (12-week induction phase followed by autologous stem cell mobilization, high-dose chemotherapy \[HDT\] and autologous stem cell transplantation \[ASCT\]; 6-week consolidation phase)- participants received lenalidomide 25 milligrams (mg) orally on Days 1 to 14 of Cycles 1 through 6), bortezomib 1.3 mg per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11 and dexamethasone 40 mg orally weekly (20 mg on Days 1, 2, 8, 9, 15 and 16); Maintenance phase (up to 104 week \[until disease progression/up to maximum of 2 years\])- participants received lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, lenalidomide dose was increased to 15 mg, unless there was tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
- id
- OG000
- title
- Randomized: Lenalidomide+Bortezomib+Dexamethasone (RVd)
- description
- Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 milligrams per kilogram (mg/kg) intravenously (IV) weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study. Per protocol amendment 4, to provide flexibility and prioritize safety during the global coronavirus-19 (COVID-19) pandemic, participants were given the option to switch from daratumumab IV to daratumumab SC at the discretion of the investigator.
- id
- OG001
- title
- Randomized: Daratumumab+RVd (D-RVd)
- description
- Induction and Consolidation Phase (12 week induction phase followed by autologous stem cell mobilization, HDT and ASCT; a 6-week consolidation phase)-participants received RVd with daratumumab 16 mg/kg IV weekly on Days 1, 8, and 15 of Cycles 1 to 4 during induction treatment and every 3 weeks on Day 1 of Cycles 5 and 6 during consolidation treatment; Maintenance phase (up to 104-week \[until disease progression/up to maximum of 2 years\])- participants received daratumumab 16 mg/kg every 4 weeks/8 weeks plus lenalidomide 10 mg orally on Days 1 to 21 throughout each 28-day cycle on Cycles 7 through 9 during maintenance treatment. Beginning at Cycle 10, the lenalidomide dose was increased to 15 mg, unless there was a tolerability concern. After 2 years of maintenance therapy, participants could continue to lenalidomide monotherapy per standard of care. Long-term follow-up phase- all participants were followed for at least 1 year after last dose of study drug and to continue until death, withdrawal of consent or end of study.
- id
- OG002
- title
- Safety Run-in: D-RVd
- param Type
- NUMBER
- population Description
- Intent to treat (ITT) analysis set which included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization to end of following: induction treatment, post-ASCT consolidation (after Cycle 6) (up to 4.5 months), and at the end of maintenance period of 24 months (overall duration up to 34 months)
- title
- Percentage of Participants With Negative Minimal Residual Disease (MRD)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice