TriangleNCT05090566 · OUTCOME
SSB: Number of Participants With DLTs- Phase 1b
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
- From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days)
What was measured
Hematological: G4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia with infection; G4 thrombocytopenia; G3 thrombocytopenia with G\>=2 bleeding. Non-hematological: G\>=4 AEs; G3 CRS (except CRS events: not been maximally treated or improved to grade \<=1 within 48 hours); G3 AEs (except: AEs attributed to CRS, G3 nausea, vomiting and diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G 3-4 laboratory abnormalities (except: not associated with clinical sequelae and improve to G=\<2 within 72 hours); Other clinically important/persistent AEs (that cause significant dose delay/reduction) may be DLT; G3 injection site reaction. CTCAE version 5.0: G1: Mild AE, G2: Moderate, G3: Severe, G4: Life-threatening consequences; urgent intervention indicated, G5: Death related to AE.
Analysis population: DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each IP were not evaluable for DLTs.
Groups in this outcome
SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1
Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.
| Group | Source count |
|---|---|
| SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- Hematological: G4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia with infection; G4 thrombocytopenia; G3 thrombocytopenia with G\>=2 bleeding. Non-hematological: G\>=4 AEs; G3 CRS (except CRS events: not been maximally treated or improved to grade \<=1 within 48 hours); G3 AEs (except: AEs attributed to CRS, G3 nausea, vomiting and diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G 3-4 laboratory abnormalities (except: not associated with clinical sequelae and improve to G=\<2 within 72 hours); Other clinically important/persistent AEs (that cause significant dose delay/reduction) may be DLT; G3 injection site reaction. CTCAE version 5.0: G1: Mild AE, G2: Moderate, G3: Severe, G4: Life-threatening consequences; urgent intervention indicated, G5: Death related to AE.
- groups
- description
- Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.
- id
- OG000
- title
- SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each IP were not evaluable for DLTs.
- reporting Status
- POSTED
- time Frame
- From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days)
- title
- SSB: Number of Participants With DLTs- Phase 1b
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice