TriangleNCT01001442 · OUTCOME
Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months).
What was measured
sCR:CR+normal FLC+absence of clonal cells in BM; CR:Negative immunofixation,disappearance of soft tissue plasmacytomas +≤5% plasma cells in BM+normal FLC; VGPR:M-protein detectable by immunofixation,not on electrophoresis or 90% or greater reduction in serum M-protein+urine M-protein level \<100mg per 24h,\>90% decrease in the difference between involved/uninvolved FLC; PR:≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h or ≥50% decrease in the difference between involved/uninvolved FLC or ≥50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%, ≥50% size reduction of soft tissue plasmacytomas; MR:25%-49% reduction of serum M-protein+reduction in 24h urinary M-protein by 50-89%(still \>200 mg/24h),25-49% soft tissue plasmacytomas size reduction,no increase in size or number of lytic bone lesions; SD:no response or PD ORR: %of subjects with MR+PR+VGPR+CR+sCR CBR:ORR + %of subjects with SD.
Analysis population: ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
Groups in this outcome
BT062 40 mg/m²
40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 50 mg/m²
50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 65 mg/m²
65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 80 mg/m²
80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 100 mg/m²
100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 120 mg/m²
120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 140 mg/m²
140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 160 mg/m²
160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Total
BT062 administration (all dose levels)
| Group | Source count |
|---|---|
| BT062 40 mg/m² | 4 |
| BT062 50 mg/m² | 3 |
| BT062 65 mg/m² | 4 |
| BT062 80 mg/m² | 3 |
| BT062 100 mg/m² | 3 |
| BT062 120 mg/m² | 3 |
| BT062 140 mg/m² | 10 |
| BT062 160 mg/m² | 4 |
| Total | 34 |
Reported measurements
Objective Response rate
yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 50 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 65 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 80 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| BT062 100 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 120 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 140 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| BT062 160 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Total | 2 | Not reported | Not reported | Not reported | Not reported |
no
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 4 | Not reported | Not reported | Not reported | Not reported |
| BT062 50 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| BT062 65 mg/m² | 4 | Not reported | Not reported | Not reported | Not reported |
| BT062 80 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| BT062 100 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| BT062 120 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| BT062 140 mg/m² | 9 | Not reported | Not reported | Not reported | Not reported |
| BT062 160 mg/m² | 4 | Not reported | Not reported | Not reported | Not reported |
| Total | 32 | Not reported | Not reported | Not reported | Not reported |
Clinical Benefit rate
yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 50 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 65 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 80 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| BT062 100 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 120 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| BT062 140 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| BT062 160 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| Total | 5 | Not reported | Not reported | Not reported | Not reported |
no
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 4 | Not reported | Not reported | Not reported | Not reported |
| BT062 50 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| BT062 65 mg/m² | 4 | Not reported | Not reported | Not reported | Not reported |
| BT062 80 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| BT062 100 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| BT062 120 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| BT062 140 mg/m² | 9 | Not reported | Not reported | Not reported | Not reported |
| BT062 160 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| Total | 29 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 2
- title
- yes
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 32
- title
- no
- title
- Objective Response rate
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 5
- title
- yes
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 29
- title
- no
- title
- Clinical Benefit rate
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 34
- units
- Participants
- description
- sCR:CR+normal FLC+absence of clonal cells in BM; CR:Negative immunofixation,disappearance of soft tissue plasmacytomas +≤5% plasma cells in BM+normal FLC; VGPR:M-protein detectable by immunofixation,not on electrophoresis or 90% or greater reduction in serum M-protein+urine M-protein level \<100mg per 24h,\>90% decrease in the difference between involved/uninvolved FLC; PR:≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 h or ≥50% decrease in the difference between involved/uninvolved FLC or ≥50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%, ≥50% size reduction of soft tissue plasmacytomas; MR:25%-49% reduction of serum M-protein+reduction in 24h urinary M-protein by 50-89%(still \>200 mg/24h),25-49% soft tissue plasmacytomas size reduction,no increase in size or number of lytic bone lesions; SD:no response or PD ORR: %of subjects with MR+PR+VGPR+CR+sCR CBR:ORR + %of subjects with SD.
- groups
- description
- 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG000
- title
- BT062 40 mg/m²
- description
- 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG001
- title
- BT062 50 mg/m²
- description
- 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG002
- title
- BT062 65 mg/m²
- description
- 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG003
- title
- BT062 80 mg/m²
- description
- 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG004
- title
- BT062 100 mg/m²
- description
- 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG005
- title
- BT062 120 mg/m²
- description
- 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG006
- title
- BT062 140 mg/m²
- description
- 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG007
- title
- BT062 160 mg/m²
- description
- BT062 administration (all dose levels)
- id
- OG008
- title
- Total
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
- reporting Status
- POSTED
- time Frame
- On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months).
- title
- Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice