TriangleNCT03269136 · OUTCOME
Part 2: TTR 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
- Days
- Interval / dispersion
- Full Range
- Time frame
- From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
What was measured
TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum\& urine \& disappearance of soft tissue plasmacytomas \& \<5% plasma cells in bone marrow aspirates. VGPR: serum\& urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein\& reduction in 24hrs urinary M-protein by \>=90% or \<200 mg/24hr. If serum \& urine M-protein unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of M-protein 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.
Groups in this outcome
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection 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.
| Group | Source count |
|---|---|
| Part 2A: PF-06863135 SC | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 40.0 | Not reported | 8 | 262 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8
- upper Limit
- 262
- value
- 40.0
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum\& urine \& disappearance of soft tissue plasmacytomas \& \<5% plasma cells in bone marrow aspirates. VGPR: serum\& urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein\& reduction in 24hrs urinary M-protein by \>=90% or \<200 mg/24hr. If serum \& urine M-protein unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of M-protein 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
- Full Range
- groups
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection 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.
- id
- OG000
- title
- Part 2A: PF-06863135 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.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
- title
- Part 2: TTR as Per IMWG Criteria
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice