TriangleNCT03269136 · OUTCOME
Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 63.31 months)
What was measured
DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum \& urine \&disappearance of any soft tissue plasmacytomas \&\<5% plasma cells in bone marrow aspirates. VGPR: serum \& urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hours urinary Mp by \>=90% or\<200 mg/24 hr. If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Analysis population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arm where it is "0" signifies there was no participant with stable disease.
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 | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 1 |
| Part 1: PF-06863135 3 mcg/kg IV | 2 |
| Part 1: PF-06863135 10 mcg/kg IV | 1 |
| Part 1: PF-06863135 30 mcg/kg IV | 3 |
| Part 1: PF-06863135 50 mcg/kg IV | 4 |
| Part 1: PF-06863135 80 mcg/kg SC | 4 |
| Part 1: PF-06863135 130 mcg/kg SC | 2 |
| Part 1: PF-06863135 215 mcg/kg SC | 4 |
| Part 1: PF-06863135 360 mcg/kg SC | 3 |
| Part 1: PF-06863135 600 mcg/kg SC | 5 |
| Part 1: PF-06863135 1000 mcg/kg SC | 5 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 9 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
| Part 1: PF-06863135 Total IV | 13 |
| Part 1: PF-06863135 Total SC | 23 |
| Part 1.1: PF-06863135 Total SC | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.3 mcg/kg IV | 1.3 | Not reported | 0.5 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | Not reported | NA | NA | Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 0.7 months. |
| Part 1: PF-06863135 3 mcg/kg IV | 0.8 | Not reported | 0.6 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 10 mcg/kg IV | NA | Not reported | NA | NA | Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.8 months. |
| Part 1: PF-06863135 30 mcg/kg IV | 3.4 | Not reported | 1.0 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 50 mcg/kg IV | 3.0 | Not reported | 2.2 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 80 mcg/kg SC | 0.4 | Not reported | 0.3 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 130 mcg/kg SC | 0.6 | Not reported | 0.5 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 215 mcg/kg SC | 18.4 | Not reported | 4.2 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 360 mcg/kg SC | 13.6 | Not reported | 5.4 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 600 mcg/kg SC | 32.2 | Not reported | 2.1 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 1000 mcg/kg SC | NA | Not reported | 7.0 | NA | The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 7.4 | Not reported | 3.7 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 17.6 | Not reported | 11.5 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1C: PF-06863135 + Lenalidomide SC | 17.9 | Not reported | 1.5 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1D: PF-06863135 + Pomalidomide SC | 5.6 | Not reported | 0.7 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 Total IV | 1.8 | Not reported | 0.6 | 3.4 | Not reported |
| Part 1: PF-06863135 Total SC | 7.3 | Not reported | 1.4 | 32.3 | Not reported |
| Part 1.1: PF-06863135 Total SC | 12.0 | Not reported | 7.4 | 20.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- NA
- value
- 1.3
- comment
- Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 0.7 months.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG003
- lower Limit
- 0.6
- upper Limit
- NA
- value
- 0.8
- comment
- Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.8 months.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG005
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 3.4
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG006
- lower Limit
- 2.2
- upper Limit
- NA
- value
- 3.0
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG007
- lower Limit
- 0.3
- upper Limit
- NA
- value
- 0.4
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG008
- lower Limit
- 0.5
- upper Limit
- NA
- value
- 0.6
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG009
- lower Limit
- 4.2
- upper Limit
- NA
- value
- 18.4
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG010
- lower Limit
- 5.4
- upper Limit
- NA
- value
- 13.6
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG011
- lower Limit
- 2.1
- upper Limit
- NA
- value
- 32.2
- comment
- The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG012
- lower Limit
- 7.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum \& urine \&disappearance of any soft tissue plasmacytomas \&\<5% plasma cells in bone marrow aspirates. VGPR: serum \& urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hours urinary Mp by \>=90% or\<200 mg/24 hr. If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arm where it is "0" signifies there was no participant with stable disease.
- reporting Status
- POSTED
- time Frame
- Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 63.31 months)
- title
- Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice