TriangleNCT02036502 · OUTCOME
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
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
- Up to 28 days in Cycle 1
What was measured
DLTs were assessed during Cycle 1 (28 days) and were defined as the occurrence of any of the following judged by the investigator to be possibly, probably or definitely related to study drug: Grade (Gr) 4 non-hematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days; Gr 3 non-hematologic toxicity lasting \>3 days; Gr 3 non-hematologic laboratory value if: medical intervention was required, abnormality led to hospitalization, was renal or liver function related, or persisted for \>1 week; Gr 3/4 febrile neutropenia; thrombocytopenia \<25,000 cells/mm\^3 (associated with bleeding requiring platelet transfusion or life-threatening bleeding); Gr 5 toxicity; or delay of \>1 week in initiating Cycle 2 or unable to complete 80% of treatment during the first course of therapy due to drug-related toxicity. DLTs for the rMM cohort were any drug-related adverse events that cannot be managed by dose modification. DLTs are reported for the maximum tolerated dose.
Analysis population: All DLT-evaluable participants in Parts 1 and 2 who received ≥1 dose of study treatment, completed Cycle 1 (28 days), or who had a DLT during the DLT evaluation period. Per protocol, DLT was not planned to be evaluated in Part 3.
Groups in this outcome
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
| Group | Source count |
|---|---|
| Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg | 6 |
| Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg | 3 |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg | 6 |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg | 1 |
| Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg | 1 |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg | 0 |
| Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg | 0 |
| Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- units
- Participants
- description
- DLTs were assessed during Cycle 1 (28 days) and were defined as the occurrence of any of the following judged by the investigator to be possibly, probably or definitely related to study drug: Grade (Gr) 4 non-hematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days; Gr 3 non-hematologic toxicity lasting \>3 days; Gr 3 non-hematologic laboratory value if: medical intervention was required, abnormality led to hospitalization, was renal or liver function related, or persisted for \>1 week; Gr 3/4 febrile neutropenia; thrombocytopenia \<25,000 cells/mm\^3 (associated with bleeding requiring platelet transfusion or life-threatening bleeding); Gr 5 toxicity; or delay of \>1 week in initiating Cycle 2 or unable to complete 80% of treatment during the first course of therapy due to drug-related toxicity. DLTs for the rMM cohort were any drug-related adverse events that cannot be managed by dose modification. DLTs are reported for the maximum tolerated dose.
- groups
- description
- Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
- id
- OG000
- title
- Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
- description
- Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG001
- title
- Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG002
- title
- Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG003
- title
- Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
- description
- Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
- id
- OG004
- title
- Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
- description
- Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
- id
- OG005
- title
- Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
- description
- Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
- id
- OG006
- title
- Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
- description
- Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
- id
- OG007
- title
- Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All DLT-evaluable participants in Parts 1 and 2 who received ≥1 dose of study treatment, completed Cycle 1 (28 days), or who had a DLT during the DLT evaluation period. Per protocol, DLT was not planned to be evaluated in Part 3.
- reporting Status
- POSTED
- time Frame
- Up to 28 days in Cycle 1
- title
- Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice