TriangleNCT00932698 · OUTCOME
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
- Not reported
- Time frame
- Cycle 1 through Cycle 115 (Up to 80.1 months)
What was measured
ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg /24 h. MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 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 participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post baseline disease assessment.
Groups in this outcome
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
| Group | Source count |
|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 2 |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 3 |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 3 |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 3 |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 2 |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 6 |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 2 |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 20 |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 11 |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 6 |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 2 |
Reported measurements
CR+PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 33 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 50 | Not reported | Not reported | Not reported | Not reported |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 9 | Not reported | Not reported | Not reported | Not reported |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 33 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
CR+PR+MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 33 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 50 | Not reported | Not reported | Not reported | Not reported |
| Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 18 | Not reported | Not reported | Not reported | Not reported |
| Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 33 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 | 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
- 33
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 50
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 33
- group Id
- OG010
- value
- 0
- title
- CR+PR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 33
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 50
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 18
- group Id
- OG009
- value
- 33
- group Id
- OG010
- value
- 0
- title
- CR+PR+MR
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 2
- units
- Participants
- description
- ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg /24 h. MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks; 25-49% reduction in the size of soft tissue plasmacytomas; no increase in the size or number of lytic bone lesions.
- groups
- description
- Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
- id
- OG000
- title
- Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
- description
- Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
- id
- OG001
- title
- Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
- description
- Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
- id
- OG002
- title
- Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
- description
- Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
- id
- OG003
- title
- Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
- description
- Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
- id
- OG004
- title
- Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
- id
- OG005
- title
- Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
- id
- OG006
- title
- Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
- id
- OG007
- title
- Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
- id
- OG008
- title
- Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determine the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor.
- id
- OG009
- title
- Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
- description
- Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
- id
- OG010
- title
- Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
- param Type
- NUMBER
- population Description
- Response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Cycle 1 through Cycle 115 (Up to 80.1 months)
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice