TriangleNCT04756401 · OUTCOME
Overall Response Rate (ORR)
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
- 95% Confidence Interval
- Time frame
- 2 years
What was measured
Will be estimated by the total number of patients who achieve a confirmed response at any time divided by the total number of evaluable patients. A confirmed response is defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) noted as the objective status on two consecutive evaluations at least two weeks apart. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. The depth of response (PR versus VGPR versus CR versus sCR) will also be summarized.
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) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor) | 75.0 | Not reported | 34.9 | 96.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.9
- upper Limit
- 96.8
- value
- 75.0
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- Will be estimated by the total number of patients who achieve a confirmed response at any time divided by the total number of evaluable patients. A confirmed response is defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) noted as the objective status on two consecutive evaluations at least two weeks apart. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. The depth of response (PR versus VGPR versus CR versus sCR) will also be summarized.
- 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
- NUMBER
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice