TriangleNCT02990338 · OUTCOME
Progression Free Survival (PFS)
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 the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)
What was measured
PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of \>=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be \>=0.5gram(g)/dL), serum M-protein increase \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute increase must be \>=200mg/24hour), appearance of new lesion(s),\>=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in the longest diameter of a previous lesion \>1 centimeter in short axis.
Analysis population: Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants.
Groups in this outcome
Pd (Pomalidomide + Dexamethasone)
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
IPd (Isatuximab + Pomalidomide + Dexamethasone)
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
| Group | Source count |
|---|---|
| Pd (Pomalidomide + Dexamethasone) | 153 |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pd (Pomalidomide + Dexamethasone) | 6.47 | Not reported | 4.468 | 8.279 | Not reported |
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 11.53 | Not reported | 8.936 | 13.897 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.436
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.814
- estimate Comment
- Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.
- group Description
- Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- p Value Comment
- One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.596
- statistical Comment
- Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.436
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.814
- estimate Comment
- Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.
- group Description
- Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- p Value Comment
- One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.596
- statistical Comment
- Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.468
- upper Limit
- 8.279
- value
- 6.47
- group Id
- OG001
- lower Limit
- 8.936
- upper Limit
- 13.897
- value
- 11.53
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of \>=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be \>=0.5gram(g)/dL), serum M-protein increase \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute increase must be \>=200mg/24hour), appearance of new lesion(s),\>=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in the longest diameter of a previous lesion \>1 centimeter in short axis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
- id
- OG000
- title
- Pd (Pomalidomide + Dexamethasone)
- description
- Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
- id
- OG001
- title
- IPd (Isatuximab + Pomalidomide + Dexamethasone)
- param Type
- MEDIAN
- population Description
- Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice