TriangleNCT03180736 · 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
- From informed consent until 30 days after last study treatment, assessed up to approximately 3 years.
What was measured
Duration of response will be restricted to the randomized subjects who achieve a best objective response of PR or better. It is measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).
Analysis population: Subjects achieving a best objective response of PR or better from the intention-to-treat population.
Groups in this outcome
Daratumumab+Pomalidomide+Dexamethasone
Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
Pomalidomide + Dexamethasone
Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
| Group | Source count |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 104 |
| Pomalidomide + Dexamethasone | 71 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | NA | Not reported | 15.21 | NA | Median and upper limit of 95% CI was not estimable due to short follow-up by participants". |
| Pomalidomide + Dexamethasone | 15.90 | Not reported | 8.31 | 24.80 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% CI was not estimable due to short follow-up by participants".
- group Id
- OG000
- lower Limit
- 15.21
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 8.31
- upper Limit
- 24.80
- value
- 15.90
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 71
- units
- Participants
- description
- Duration of response will be restricted to the randomized subjects who achieve a best objective response of PR or better. It is measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG000
- title
- Daratumumab+Pomalidomide+Dexamethasone
- description
- Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
- id
- OG001
- title
- Pomalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- Subjects achieving a best objective response of PR or better from the intention-to-treat population.
- reporting Status
- POSTED
- time Frame
- From informed consent until 30 days after last study treatment, assessed up to approximately 3 years.
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice