TriangleNCT06655818 · OUTCOME
DE Phase: Number of Participants With Dose Limiting Toxicities (DLT)
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 21 days
What was measured
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLTs. Severity was graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (version 5.0).
Analysis population: DLT Evaluable Population included participants in DE who have received the first course of treatment containing both agents within a sub-study and followed up within cycle 1 (Each cycle is of 21 days) or withdrew within cycle 1 due to an AE meeting the definition of a DLT.
Groups in this outcome
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).
| Group | Source count |
|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- units
- Participants
- description
- Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLTs. Severity was graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (version 5.0).
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).
- id
- OG000
- title
- 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT Evaluable Population included participants in DE who have received the first course of treatment containing both agents within a sub-study and followed up within cycle 1 (Each cycle is of 21 days) or withdrew within cycle 1 due to an AE meeting the definition of a DLT.
- reporting Status
- POSTED
- time Frame
- Up to 21 days
- title
- DE Phase: Number of Participants With Dose Limiting Toxicities (DLT)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice