NCT04756401 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2 years
What was measured
Duration of response (DOR) is defined as time from date at which the patient's confirmed objective status is noted to the earliest date of progression or death. The DOR will be estimated using the method of Kaplan-Meier.
Analysis population: Only patients with a confirmed response are included in analysis
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) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor) | NA | Not reported | NA | NA | Median duration or response and CI are not able to be estimated due to a low number of progression or death events |
Complete source fields
- classes
- categories
- measurements
- comment
- Median duration or response and CI are not able to be estimated due to a low number of progression or death events
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Duration of response (DOR) is defined as time from date at which the patient's confirmed objective status is noted to the earliest date of progression or death. The DOR will be estimated using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- 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)
- param Type
- MEDIAN
- population Description
- Only patients with a confirmed response are included in analysis
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice
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