TriangleNCT04512235 · OUTCOME
Change From Baseline in Global Longitudinal Strain (GLS%)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of myocardial shortening
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 50
What was measured
Change in heart function was measured by GLS%, a noninvasive imaging technique that uses echocardiography to assess heart. GLS% expresses longitudinal shortening as a percentage (change in length as a proportion to baseline length) and is reported as a negative value. A more negative value is usually associated with cardiac enhancement.
Analysis population: Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signifies those participants evaluable for this outcome measure.
Groups in this outcome
CAEL-101 + Plasma Cell Dyscrasia Treatment
During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
Placebo + Plasma Cell Dyscrasia Treatment
During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 105 |
| Placebo + Plasma Cell Dyscrasia Treatment | 54 |
Reported measurements
Overall (All Randomized Participants)
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 105 |
| Placebo + Plasma Cell Dyscrasia Treatment | 54 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 0.05 | 3.666 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | -0.60 | 4.148 | Not reported | Not reported | Not reported |
FLC Subtype Kappa
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 12 |
| Placebo + Plasma Cell Dyscrasia Treatment | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 0.41 | 4.595 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | -1.11 | 4.669 | Not reported | Not reported | Not reported |
FLC Subtype Lambda
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 91 |
| Placebo + Plasma Cell Dyscrasia Treatment | 42 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | -0.09 | 3.501 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | -0.45 | 4.100 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.666
- value
- 0.05
- group Id
- OG001
- spread
- 4.148
- value
- -0.60
- denoms
- counts
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 54
- units
- Participants
- title
- Overall (All Randomized Participants)
- categories
- measurements
- group Id
- OG000
- spread
- 4.595
- value
- 0.41
- group Id
- OG001
- spread
- 4.669
- value
- -1.11
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- FLC Subtype Kappa
- categories
- measurements
- group Id
- OG000
- spread
- 3.501
- value
- -0.09
- group Id
- OG001
- spread
- 4.100
- value
- -0.45
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 42
- units
- Participants
- title
- FLC Subtype Lambda
- denoms
- counts
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- Change in heart function was measured by GLS%, a noninvasive imaging technique that uses echocardiography to assess heart. GLS% expresses longitudinal shortening as a percentage (change in length as a proportion to baseline length) and is reported as a negative value. A more negative value is usually associated with cardiac enhancement.
- dispersion Type
- Standard Deviation
- groups
- description
- During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
- id
- OG000
- title
- CAEL-101 + Plasma Cell Dyscrasia Treatment
- description
- During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
- id
- OG001
- title
- Placebo + Plasma Cell Dyscrasia Treatment
- param Type
- MEAN
- population Description
- Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signifies those participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 50
- title
- Change From Baseline in Global Longitudinal Strain (GLS%)
- type
- SECONDARY
- unit Of Measure
- percentage of myocardial shortening
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice