TriangleNCT03269136 · OUTCOME
Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03
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 (21 Days)
What was measured
Hematological: Grade 4 neutropenia lasting \>5 days; Febrile neutropenia \<1000/mm\^3 with a single temperature of \>38.3 degree Celsius (C) or a sustained temperature of \>=38 degree C for more than one hour; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with \>= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting \>=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to \<=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.
Analysis population: DLT evaluable set included all participants that had experienced a DLT in the DLT observation period or received all of their planned doses of PF-06863135 in the initial DLT observation period if Q2W dosing was being evaluated or at least all but one of their planned doses of PF-0686135 if Q1W dosing was being evaluated, provided a dose was not missed due to toxicity attributed to study drug.
Groups in this outcome
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 3 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 6 |
| Part 1: PF-06863135 80 mcg/kg SC | 6 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 4 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 5 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 9 |
| Part 1C: PF-06863135 + Lenalidomide SC | 2 |
| Part 1D: PF-06863135 + Pomalidomide SC | 6 |
| Part 1: PF-06863135 Total IV | 23 |
| Part 1: PF-06863135 Total SC | 30 |
| Part 1.1: PF-06863135 Total SC | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 0.3 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 3 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 30 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 Total SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Total SC | 1 | 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
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Hematological: Grade 4 neutropenia lasting \>5 days; Febrile neutropenia \<1000/mm\^3 with a single temperature of \>38.3 degree Celsius (C) or a sustained temperature of \>=38 degree C for more than one hour; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with \>= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting \>=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to \<=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.
- groups
- description
- Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG000
- title
- Part 1: PF-06863135 0.1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG001
- title
- Part 1: PF-06863135 0.3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG002
- title
- Part 1: PF-06863135 1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG003
- title
- Part 1: PF-06863135 3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG004
- title
- Part 1: PF-06863135 10 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG005
- title
- Part 1: PF-06863135 30 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG006
- title
- Part 1: PF-06863135 50 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG007
- title
- Part 1: PF-06863135 80 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG008
- title
- Part 1: PF-06863135 130 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG009
- title
- Part 1: PF-06863135 215 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG010
- title
- Part 1: PF-06863135 360 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG011
- title
- Part 1: PF-06863135 600 mcg/kg SC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT evaluable set included all participants that had experienced a DLT in the DLT observation period or received all of their planned doses of PF-06863135 in the initial DLT observation period if Q2W dosing was being evaluated or at least all but one of their planned doses of PF-0686135 if Q1W dosing was being evaluated, provided a dose was not missed due to toxicity attributed to study drug.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (21 Days)
- title
- Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice