TriangleNCT03269136 · OUTCOME
Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy whichever occurred first (maximum up to 34.3 months)
What was measured
MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as 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. MRD negativity was defined by two thresholds, 10\^-5 and 10\^-6.
Analysis population: Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.
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 | 15 |
Reported measurements
10^-5 threshold MRD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 33.33 | Not reported | Not reported | Not reported | Not reported |
10^-6 threshold MRD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 13.33 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 33.33
- title
- 10^-5 threshold MRD
- categories
- measurements
- group Id
- OG000
- value
- 13.33
- title
- 10^-6 threshold MRD
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as 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. MRD negativity was defined by two thresholds, 10\^-5 and 10\^-6.
- 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
- NUMBER
- population Description
- Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.
- reporting Status
- POSTED
- time Frame
- Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy whichever occurred first (maximum up to 34.3 months)
- title
- Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice