TriangleNCT03450057 · OUTCOME
The Evaluation of Progression Free Survival (PFS) in Subjects With Relapsed or Refractory Multiple Myeloma and Renal Impairment Treated With Daratumumab and Dexamethasone.
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
- Duration from first daratumumab administration until death or last assessment, months.
What was measured
Progression free survival was defined as the time, in months, from treatment initiation (C1D1) to the date of the first documented disease progression or death due to any cause, whichever came first. Clinical deterioration was not considered progression. For patients who neither progressed nor died, the survival time was censored at the date of their last disease assessment. For patients who started a new anti-tumor treatment, survival time was censored at the date of the start of the new treatment.
Analysis population: Kaplan-Meier estimates for progression-free survival (PFS) in months.
Groups in this outcome
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended 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. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 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.
| Group | Source count |
|---|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD) | 11.8 | Not reported | 2.8 | 20.8 | Not reported |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Comment
- The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.
- non Inferiority Type
- OTHER
- other Analysis Description
- The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Comment
- The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.
- non Inferiority Type
- OTHER
- other Analysis Description
- The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 20.8
- value
- 11.8
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- Progression free survival was defined as the time, in months, from treatment initiation (C1D1) to the date of the first documented disease progression or death due to any cause, whichever came first. Clinical deterioration was not considered progression. For patients who neither progressed nor died, the survival time was censored at the date of their last disease assessment. For patients who started a new anti-tumor treatment, survival time was censored at the date of the start of the new treatment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended 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. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 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
- Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
- param Type
- MEDIAN
- population Description
- Kaplan-Meier estimates for progression-free survival (PFS) in months.
- reporting Status
- POSTED
- time Frame
- Duration from first daratumumab administration until death or last assessment, months.
- title
- The Evaluation of Progression Free Survival (PFS) in Subjects With Relapsed or Refractory Multiple Myeloma and Renal Impairment Treated With Daratumumab and Dexamethasone.
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice