TriangleNCT03269136 · OUTCOME
Part 1: Duration of Complete Response (DoCR) 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
- From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 63.31 months)
What was measured
DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or 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 arms where it is "0" signifies there was no participant with complete response.
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 | 0 |
| Part 1: PF-06863135 1 mcg/kg IV | 0 |
| Part 1: PF-06863135 3 mcg/kg IV | 0 |
| Part 1: PF-06863135 10 mcg/kg IV | 0 |
| Part 1: PF-06863135 30 mcg/kg IV | 0 |
| Part 1: PF-06863135 50 mcg/kg IV | 0 |
| Part 1: PF-06863135 80 mcg/kg SC | 0 |
| Part 1: PF-06863135 130 mcg/kg SC | 0 |
| Part 1: PF-06863135 215 mcg/kg SC | 2 |
| Part 1: PF-06863135 360 mcg/kg SC | 1 |
| Part 1: PF-06863135 600 mcg/kg SC | 3 |
| Part 1: PF-06863135 1000 mcg/kg SC | 3 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 1 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 6 |
| Part 1C: PF-06863135 + Lenalidomide SC | 2 |
| Part 1D: PF-06863135 + Pomalidomide SC | 3 |
| Part 1: PF-06863135 Total IV | 0 |
| Part 1: PF-06863135 Total SC | 9 |
| Part 1.1: PF-06863135 Total SC | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 215 mcg/kg SC | 25.3 | Not reported | 18.4 | 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 | NA | Not reported | NA | NA | Median and CI could not be reported as participant did not have event. |
| Part 1: PF-06863135 600 mcg/kg SC | NA | Not reported | NA | NA | Only one participant had event, hence median and CI not reported. Individual participant data was 31.5 months. |
| 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 | NA | Not reported | NA | NA | Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.9 months. |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | NA | Not reported | 6.5 | NA | The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events |
| Part 1C: PF-06863135 + Lenalidomide SC | NA | Not reported | 10.3 | NA | The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1D: PF-06863135 + Pomalidomide SC | NA | Not reported | 3.7 | NA | The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
| Part 1: PF-06863135 Total SC | 31.5 | Not reported | 7.0 | NA | The upper limit of 95% CI was not estimable due to low number of participants with events. |
| Part 1.1: PF-06863135 Total SC | 11.5 | Not reported | 1.9 | NA | The upper limit of 95% CI was not estimable due to low number of participants with events. |
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
- OG009
- lower Limit
- 18.4
- upper Limit
- NA
- value
- 25.3
- comment
- Median and CI could not be reported as participant did not have event.
- group Id
- OG010
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Only one participant had event, hence median and CI not reported. Individual participant data was 31.5 months.
- group Id
- OG011
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- 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
- comment
- Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.9 months.
- group Id
- OG013
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events
- group Id
- OG014
- lower Limit
- 6.5
- upper Limit
- NA
- value
- NA
- comment
- The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG015
- lower Limit
- 10.3
- upper Limit
- NA
- value
- NA
- comment
- The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG016
- lower Limit
- 3.7
- upper Limit
- NA
- value
- NA
- comment
- The upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG018
- lower Limit
- 7.0
- upper Limit
- NA
- value
- 31.5
- comment
- The upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG019
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 11.5
- denoms
- counts
- 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
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or 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 arms where it is "0" signifies there was no participant with complete response.
- reporting Status
- POSTED
- time Frame
- From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 63.31 months)
- title
- Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice