NCT04756401 · OUTCOME
MRD Negativity Rate at 10^-6 of Sensitivity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- 2 years
What was measured
Will be assessed in the bone marrow by flow cytometry estimated as the number of patients who have achieved MRD negative result at 10\^-6 level of sensitivity at any time divided by the total number of evaluable patients. Exact 95% binomial confidence intervals for the true rate of MRD negative response will also be calculated.
Analysis population: Flow cytometry was not performed on collected samples and will never be performed due to early trial closure. Therefore, MRD is able to be assessed for 0 patients.
Groups in this outcome
Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)
Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15 and daratumumab IV on days 1 and 2 of cycle 1 then days 8, 15, and 22 of cycle 1, then, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8 15, and 22, and selinexor PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Carfilzomib: Given IV \> \> Daratumumab: Given IV \> \> Dexamethasone: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> Selinexor: Given PO
| Group | Source count |
|---|---|
| Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- Will be assessed in the bone marrow by flow cytometry estimated as the number of patients who have achieved MRD negative result at 10\^-6 level of sensitivity at any time divided by the total number of evaluable patients. Exact 95% binomial confidence intervals for the true rate of MRD negative response will also be calculated.
- groups
- description
- Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15 and daratumumab IV on days 1 and 2 of cycle 1 then days 8, 15, and 22 of cycle 1, then, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8 15, and 22, and selinexor PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Carfilzomib: Given IV \> \> Daratumumab: Given IV \> \> Dexamethasone: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> Selinexor: Given PO
- id
- OG000
- title
- Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)
- population Description
- Flow cytometry was not performed on collected samples and will never be performed due to early trial closure. Therefore, MRD is able to be assessed for 0 patients.
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- MRD Negativity Rate at 10^-6 of Sensitivity
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
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