TriangleNCT04504825 · OUTCOME
Change From Baseline in Distance Walked During a Six-minute Walk Test (6MWT)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- meters
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 50
What was measured
The 6MWT measures the distance a participant can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated response of all the systems involved during exercise. This is a self-paced test; participants choose their own intensity of exercise and are allowed to stop and rest during the test.
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 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.
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 35 |
| Placebo + Plasma Cell Dyscrasia Treatment | 16 |
Reported measurements
Overall (All Randomized Participants)
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 35 |
| Placebo + Plasma Cell Dyscrasia Treatment | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 32.557 | 145.1971 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 55.692 | 99.7105 | Not reported | Not reported | Not reported |
FLC Subtype Kappa
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 12 |
| Placebo + Plasma Cell Dyscrasia Treatment | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 34.556 | 143.9645 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 26.000 | Not reported | Not reported | Not reported | Not reported |
FLC Subtype Lambda
| Group | Source count |
|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 22 |
| Placebo + Plasma Cell Dyscrasia Treatment | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAEL-101 + Plasma Cell Dyscrasia Treatment | 42.264 | 143.1377 | Not reported | Not reported | Not reported |
| Placebo + Plasma Cell Dyscrasia Treatment | 57.671 | 102.88433 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 145.1971
- value
- 32.557
- group Id
- OG001
- spread
- 99.7105
- value
- 55.692
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Overall (All Randomized Participants)
- categories
- measurements
- group Id
- OG000
- spread
- 143.9645
- value
- 34.556
- group Id
- OG001
- value
- 26.000
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- FLC Subtype Kappa
- categories
- measurements
- group Id
- OG000
- spread
- 143.1377
- value
- 42.264
- group Id
- OG001
- spread
- 102.88433
- value
- 57.671
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- FLC Subtype Lambda
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- The 6MWT measures the distance a participant can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated response of all the systems involved during exercise. This is a self-paced test; participants choose their own intensity of exercise and are allowed to stop and rest during the test.
- 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 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
- 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 Distance Walked During a Six-minute Walk Test (6MWT)
- type
- SECONDARY
- unit Of Measure
- meters
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice