TriangleNCT02937571 · OUTCOME
Number of Patients With Dose Limiting Toxicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1, up to 28 days
What was measured
To find the maximum tolerated dose.A DLT is defined as any of the below toxicities with attribution to one or more of the study drugs that occur during Cycle 1. All AEs should be considered relevant to determining dose-limiting toxicities and to reporting unless the event can clearly be determined to be UNRELATED to the drug. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Groups in this outcome
Dose Level 1: Carfilzomib 45mg/m2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
Dose Level 2: Carfilzomib 56mg/m2/Dose
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
MTD: Carfilzomib
* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
| Group | Source count |
|---|---|
| Dose Level 1: Carfilzomib 45mg/m2/Dose | 3 |
| Dose Level 2: Carfilzomib 56mg/m2/Dose | 3 |
| MTD: Carfilzomib | 23 |
Reported measurements
Source class 1
Number of participants with DLT
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1: Carfilzomib 45mg/m2/Dose | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2: Carfilzomib 56mg/m2/Dose | 0 | Not reported | Not reported | Not reported | Not reported |
| MTD: Carfilzomib | 0 | Not reported | Not reported | Not reported | Not reported |
Number of participants without DLT
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1: Carfilzomib 45mg/m2/Dose | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2: Carfilzomib 56mg/m2/Dose | 3 | Not reported | Not reported | Not reported | Not reported |
| MTD: Carfilzomib | 23 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Number of participants with DLT
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 23
- title
- Number of participants without DLT
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 23
- units
- Participants
- description
- To find the maximum tolerated dose.A DLT is defined as any of the below toxicities with attribution to one or more of the study drugs that occur during Cycle 1. All AEs should be considered relevant to determining dose-limiting toxicities and to reporting unless the event can clearly be determined to be UNRELATED to the drug. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
- groups
- description
- * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
- id
- OG000
- title
- Dose Level 1: Carfilzomib 45mg/m2/Dose
- description
- * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
- id
- OG001
- title
- Dose Level 2: Carfilzomib 56mg/m2/Dose
- description
- * Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23 Carfilzomib Lenalidomide Dexamethasone
- id
- OG002
- title
- MTD: Carfilzomib
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Cycle 1, up to 28 days
- title
- Number of Patients With Dose Limiting Toxicity
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice