TriangleNCT03269136 · OUTCOME
Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135
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 first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 63.31 months)
What was measured
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).
Analysis population: The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
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.
| 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 | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 13 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
Reported measurements
ADA positive
| 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 | 1 | 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 | 2 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 1 | 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 | 1 | 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 0 | Not reported | Not reported | Not reported | Not reported |
NAb positive
| 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 | 1 | 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 | 1 | 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 0 | 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
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- title
- ADA positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- NAb positive
- 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
- Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).
- 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
- The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 63.31 months)
- title
- Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice