TriangleNCT01559935 · OUTCOME
MRD Negativity Following CarBiRD Regimen
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 start of study up to Revlimid Maintenance Cycle 4.
What was measured
Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on. MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy. MRD positivity is defined as the presence of residual plasma cells (\<5%) on bone marrow biopsy. The IMWG criteria were used to determine CR and sCR.
Analysis population: 28 participants achieved CR or sCR.
Groups in this outcome
Car-BiRD Therapy
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
| Group | Source count |
|---|---|
| Car-BiRD Therapy | 28 |
Reported measurements
Source class 1
MRD positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Car-BiRD Therapy | 10 | Not reported | Not reported | Not reported | Not reported |
MRD negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Car-BiRD Therapy | 17 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Car-BiRD Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- MRD positive
- measurements
- group Id
- OG000
- value
- 17
- title
- MRD negative
- measurements
- group Id
- OG000
- value
- 1
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 28
- units
- Participants
- description
- Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on. MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy. MRD positivity is defined as the presence of residual plasma cells (\<5%) on bone marrow biopsy. The IMWG criteria were used to determine CR and sCR.
- groups
- description
- Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
- id
- OG000
- title
- Car-BiRD Therapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 28 participants achieved CR or sCR.
- reporting Status
- POSTED
- time Frame
- From start of study up to Revlimid Maintenance Cycle 4.
- title
- MRD Negativity Following CarBiRD Regimen
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice