TriangleNCT03652064 · OUTCOME
Primary Analysis: Overall Minimal Residual Disease (MRD) Negative Rate
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 (Day 1) up to 27.9 months
What was measured
Overall MRD negativity rate was defined as the percentage of participants who achieved complete response (CR) or better response and had MRD negative status (at 10\^5) by bone marrow biopsy or aspirate after randomization but prior to progressive disease (PD), subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent anti-myeloma therapy in accordance with the International Myeloma Working Group (IMWG) criteria during or after the study treatment. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (\<) 5 percent (%) plasma cells (PCs) in bone marrow. sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Analysis population: The intent-to-treat (ITT) analysis set included all participants who had been randomly assigned to the D-VRd or VRd group.
Groups in this outcome
Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
| Group | Source count |
|---|---|
| Arm A: Bortezomib-lenalidomide-dexamethasone (VRd) | 198 |
| Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd) | 197 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Bortezomib-lenalidomide-dexamethasone (VRd) | 35.4 | Not reported | 28.7 | 42.4 | Not reported |
| Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd) | 53.3 | Not reported | 46.1 | 60.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.10
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.0004
- param Type
- Odds Ratio (OR)
- param Value
- 2.07
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Lower Limit
- 1.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.10
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.0004
- param Type
- Odds Ratio (OR)
- param Value
- 2.07
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.7
- upper Limit
- 42.4
- value
- 35.4
- group Id
- OG001
- lower Limit
- 46.1
- upper Limit
- 60.4
- value
- 53.3
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 197
- units
- Participants
- description
- Overall MRD negativity rate was defined as the percentage of participants who achieved complete response (CR) or better response and had MRD negative status (at 10\^5) by bone marrow biopsy or aspirate after randomization but prior to progressive disease (PD), subsequent anti-myeloma therapy, or both. CR or better rate was defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent anti-myeloma therapy in accordance with the International Myeloma Working Group (IMWG) criteria during or after the study treatment. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (\<) 5 percent (%) plasma cells (PCs) in bone marrow. sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with multiple myeloma received a single dose of bortezomib 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 milligrams (mg) capsule were administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single dose oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 during Cycle 1 to 8. Participants aged greater than \[\>\]75 years or underweight (body mass index \[BMI\] less than \[\<\]18.5 kilograms per meters \[kg/m\^2\]) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
- id
- OG000
- title
- Arm A: Bortezomib-lenalidomide-dexamethasone (VRd)
- description
- Participants with multiple myeloma received a single dose of daratumumab 1800 mg as SC injection once every week in Cycles 1-2, every 3 weeks in Cycles 3-8, and every 4 weeks in Cycle 9 and beyond until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m\^2 SC injection was administered twice weekly on Days 1, 4, 8 and 11 of Cycles 1 to 8. Lenalidomide 25 mg capsule was administered orally once daily from Day 1 to Day 14 of Cycles 1 to 8. Starting from Cycle 9, Lenalidomide capsules were administered orally once daily from Day 1 to Day 21 of each cycle until disease progression or unacceptable toxicity during treatment phase. Dexamethasone 20 mg was administered as a single oral tablet on Days 1, 2, 4, 5, 8, 9, 11, 12 of Cycle 1 to 8. Participants aged \>75 years or underweight (BMI \<18.5 kg/m\^2) were administered with Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle. Starting from Cycle 9, Dexamethasone 40 mg was administered as a single tablet orally on Days 1, 8, 15, and 22 of each cycle until disease progression or unacceptable toxicity during treatment phase. Cycles 1 to 8 were 21 days each while Cycles 9 and beyond were 28 days each.
- id
- OG001
- title
- Arm B: Daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd)
- param Type
- NUMBER
- population Description
- The intent-to-treat (ITT) analysis set included all participants who had been randomly assigned to the D-VRd or VRd group.
- reporting Status
- POSTED
- time Frame
- From randomization (Day 1) up to 27.9 months
- title
- Primary Analysis: Overall Minimal Residual Disease (MRD) Negative Rate
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice