TriangleNCT00963820 · OUTCOME
Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time
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 354 days
What was measured
Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Partial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas. Minimal Response (MR)= 25-49% reduction in serum paraprotein for 6 weeks. 50-89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25-49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25-49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions.
Analysis population: Response-Evaluable Population included all participants who had measurable disease at Baseline, had received at least 1 dose of study drug, and had at least 1 post-baseline response assessment.
Groups in this outcome
0.24 mg/m^2
Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
0.48 mg/m^2
Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
0.80 mg/m^2
Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
1.20 mg/m^2
Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
1.68 mg/m^2
Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
2.23 mg/m^2
Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
2.97 mg/m^2
Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
3.95 mg/m^2
Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
Relapsed and Refractory (RR)
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
VELCADE-relapsed (VR)
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
PI naïve
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
Carfilzomib
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
| Group | Source count |
|---|---|
| 0.24 mg/m^2 | 2 |
| 0.48 mg/m^2 | 3 |
| 0.80 mg/m^2 | 2 |
| 1.20 mg/m^2 | 3 |
| 1.68 mg/m^2 | 2 |
| 2.23 mg/m^2 | 3 |
| 2.97 mg/m^2 | 4 |
| 3.95 mg/m^2 | 4 |
| Relapsed and Refractory (RR) | 11 |
| VELCADE-relapsed (VR) | 9 |
| PI naïve | 6 |
| Carfilzomib | 4 |
Reported measurements
CR + PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.24 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 0.48 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 0.80 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 1.20 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 1.68 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 2.23 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 2.97 mg/m^2 | 25 | Not reported | 0 | 81 | Not reported |
| 3.95 mg/m^2 | 25 | Not reported | 0 | 81 | Not reported |
| Relapsed and Refractory (RR) | 9 | Not reported | 0 | 41 | Not reported |
| VELCADE-relapsed (VR) | 22 | Not reported | 3 | 60 | Not reported |
| PI naïve | 17 | Not reported | 0 | 64 | Not reported |
| Carfilzomib | 25 | Not reported | 0 | 81 | Not reported |
CR + PR + MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.24 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 0.48 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 0.80 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 1.20 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 1.68 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 2.23 mg/m^2 | 0 | Not reported | 0 | 0 | Not reported |
| 2.97 mg/m^2 | 25 | Not reported | 0 | 81 | Not reported |
| 3.95 mg/m^2 | 25 | Not reported | 0 | 81 | Not reported |
| Relapsed and Refractory (RR) | 18 | Not reported | 2 | 52 | Not reported |
| VELCADE-relapsed (VR) | 33 | Not reported | 7 | 70 | Not reported |
| PI naïve | 17 | Not reported | 0 | 64 | Not reported |
| Carfilzomib | 25 | Not reported | 0 | 81 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG006
- lower Limit
- 0
- upper Limit
- 81
- value
- 25
- group Id
- OG007
- lower Limit
- 0
- upper Limit
- 81
- value
- 25
- group Id
- OG008
- lower Limit
- 0
- upper Limit
- 41
- value
- 9
- group Id
- OG009
- lower Limit
- 3
- upper Limit
- 60
- value
- 22
- group Id
- OG010
- lower Limit
- 0
- upper Limit
- 64
- value
- 17
- group Id
- OG011
- lower Limit
- 0
- upper Limit
- 81
- value
- 25
- title
- CR + PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG006
- lower Limit
- 0
- upper Limit
- 81
- value
- 25
- group Id
- OG007
- lower Limit
- 0
- upper Limit
- 81
- value
- 25
- group Id
- OG008
- lower Limit
- 2
- upper Limit
- 52
- value
- 18
- group Id
- OG009
- lower Limit
- 7
- upper Limit
- 70
- value
- 33
- group Id
- OG010
- lower Limit
- 0
- upper Limit
- 64
- value
- 17
- group Id
- OG011
- lower Limit
- 0
- upper Limit
- 81
- value
- 25
- title
- CR + PR + MR
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 6
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Partial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas. Minimal Response (MR)= 25-49% reduction in serum paraprotein for 6 weeks. 50-89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25-49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25-49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG000
- title
- 0.24 mg/m^2
- description
- Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG001
- title
- 0.48 mg/m^2
- description
- Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG002
- title
- 0.80 mg/m^2
- description
- Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG003
- title
- 1.20 mg/m^2
- description
- Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG004
- title
- 1.68 mg/m^2
- description
- Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG005
- title
- 2.23 mg/m^2
- description
- Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG006
- title
- 2.97 mg/m^2
- description
- Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG007
- title
- 3.95 mg/m^2
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG008
- title
- Relapsed and Refractory (RR)
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG009
- title
- VELCADE-relapsed (VR)
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG010
- title
- PI naïve
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG011
- title
- Carfilzomib
- param Type
- NUMBER
- population Description
- Response-Evaluable Population included all participants who had measurable disease at Baseline, had received at least 1 dose of study drug, and had at least 1 post-baseline response assessment.
- reporting Status
- POSTED
- time Frame
- Up to 354 days
- title
- Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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