TriangleNCT02389517 · OUTCOME
Percentage of Participants With MRD Negativity
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
- Not reported
- Time frame
- At 12 months
What was measured
Rate of MRD negativity after 12 months of treatment with Ixazomib in combination with lenalidomide and dexamethasone compared to MRD negativity rate after 12 months of lenalidomide alone. For the majority of patients, where MRD positivity at screening will be determined by Multi-parameter Flow Cytometry (MFC), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by MFC. Additionally, in the fraction of patients with MRD-negative disease by MFC at screening, who were MRD-positive by Next Generation Sequencing (NGS), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by NGS
Analysis population: The data for 3 patients in Arm 1 AND 4 patients in Arm II were not collected.
Groups in this outcome
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only). Ixazomib Citrate: Given PO Lenalidomide: Given PO Dexamethasone: Given PO
Arm II (Lenalidomide)
Patients receive lenalidomide PO as in Arm I. Lenalidomide: Given PO
| Group | Source count |
|---|---|
| Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone) | 11 |
| Arm II (Lenalidomide) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone) | 18 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Lenalidomide) | 31 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 31
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Rate of MRD negativity after 12 months of treatment with Ixazomib in combination with lenalidomide and dexamethasone compared to MRD negativity rate after 12 months of lenalidomide alone. For the majority of patients, where MRD positivity at screening will be determined by Multi-parameter Flow Cytometry (MFC), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by MFC. Additionally, in the fraction of patients with MRD-negative disease by MFC at screening, who were MRD-positive by Next Generation Sequencing (NGS), an improvement will be defined as a conversion from MRD-positive to MRD-negative disease by NGS
- groups
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only). Ixazomib Citrate: Given PO Lenalidomide: Given PO Dexamethasone: Given PO
- id
- OG000
- title
- Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
- description
- Patients receive lenalidomide PO as in Arm I. Lenalidomide: Given PO
- id
- OG001
- title
- Arm II (Lenalidomide)
- param Type
- NUMBER
- population Description
- The data for 3 patients in Arm 1 AND 4 patients in Arm II were not collected.
- reporting Status
- POSTED
- time Frame
- At 12 months
- title
- Percentage of Participants With MRD Negativity
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice