TriangleNCT03439280 · OUTCOME
Phase 1: Overall Response Rate (ORR)
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
- 95% Confidence Interval
- Time frame
- Up to approximately 3.7 years
What was measured
ORR is defined as the percentage of participants who achieved a partial response (PR) or better during the study. PR is defined as \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours. If the serum and urine M-protein were not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum FLC was also not measurable, ≥50% reduction in bone marrow plasma cells was required in place of M-protein, provided the baseline percentage was ≥30%. In addition to the above criteria, if present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas was also required. Two consecutive assessments were needed; no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages are rounded off to whole number at the nearest decimal.
Analysis population: Response-evaluable analysis set is a subset of the safety analysis set including participants with measurable disease at baseline and at least 1 posttreatment evaluation.
Groups in this outcome
Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 4 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 3 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 12 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 19 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 3 |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 25 | Not reported | 0.6 | 80.6 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 0 | Not reported | 0 | 0 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 42 | Not reported | 15.2 | 72.3 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 47 | Not reported | 24.4 | 71.1 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 33 | Not reported | 0.8 | 90.6 | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 83 | Not reported | 35.9 | 99.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 80.6
- value
- 25
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 15.2
- upper Limit
- 72.3
- value
- 42
- group Id
- OG003
- lower Limit
- 24.4
- upper Limit
- 71.1
- value
- 47
- group Id
- OG004
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33
- group Id
- OG005
- lower Limit
- 35.9
- upper Limit
- 99.6
- value
- 83
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- ORR is defined as the percentage of participants who achieved a partial response (PR) or better during the study. PR is defined as \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours. If the serum and urine M-protein were not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. If serum and urine M-protein were not measurable, and serum FLC was also not measurable, ≥50% reduction in bone marrow plasma cells was required in place of M-protein, provided the baseline percentage was ≥30%. In addition to the above criteria, if present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas was also required. Two consecutive assessments were needed; no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages are rounded off to whole number at the nearest decimal.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.
- id
- OG000
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
- description
- Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG001
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
- description
- Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG002
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
- description
- Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG003
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
- description
- Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG004
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
- description
- Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
- id
- OG005
- title
- Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
- param Type
- NUMBER
- population Description
- Response-evaluable analysis set is a subset of the safety analysis set including participants with measurable disease at baseline and at least 1 posttreatment evaluation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 3.7 years
- title
- Phase 1: Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice