TriangleNCT03710603 · OUTCOME
Overall MRD Negativity Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization to the clinical cutoff date. Maximum follow up was 54.41 months.
What was measured
Overall MRD-negativity rate was defined as the percentage of participants in the ITT population who achieved both MRD-negativity by NGS (at or below a sensitivity threshold of 10-5) in bone marrow aspirate and a CR or better response at any time after the date of randomization (and prior to disease progression, receipt of subsequent therapy, or both).
Analysis population: Randomized population, intention-to-treat
Groups in this outcome
Velcade Lenalidomide Dexamethasone (VRd)
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
Daratumumab + VRd (D-VRd)
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
| Group | Source count |
|---|---|
| Velcade Lenalidomide Dexamethasone (VRd) | 354 |
| Daratumumab + VRd (D-VRd) | 355 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade Lenalidomide Dexamethasone (VRd) | 168 | Not reported | Not reported | Not reported | Not reported |
| Daratumumab + VRd (D-VRd) | 267 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 267
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 355
- units
- Participants
- description
- Overall MRD-negativity rate was defined as the percentage of participants in the ITT population who achieved both MRD-negativity by NGS (at or below a sensitivity threshold of 10-5) in bone marrow aspirate and a CR or better response at any time after the date of randomization (and prior to disease progression, receipt of subsequent therapy, or both).
- groups
- description
- Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
- id
- OG000
- title
- Velcade Lenalidomide Dexamethasone (VRd)
- description
- Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
- id
- OG001
- title
- Daratumumab + VRd (D-VRd)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Randomized population, intention-to-treat
- reporting Status
- POSTED
- time Frame
- From randomization to the clinical cutoff date. Maximum follow up was 54.41 months.
- title
- Overall MRD Negativity Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice