TriangleNCT01864018 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
What was measured
The distribution of PFS will be estimated using the method of Kaplan Meier.
Groups in this outcome
Phase I/II, Cohort A
Patients with multiple myeloma\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies\> \>\> \> \>\> Patient has multiple myeloma at baseline
Phase II, Cohort B
Patients with biopsy proven light chain amyloidosis with organ involvement requiring therapy\> \> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies\> \>\> \> \>\> Patient has light chain amyloidosis at baseline
| Group | Source count |
|---|---|
| Phase I/II, Cohort A | 48 |
| Phase II, Cohort B | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I/II, Cohort A | NA | Not reported | 31.3 | NA | Median and upper 95% CI PFS was not reached due to the low number of progressions (11) |
| Phase II, Cohort B | NA | Not reported | 39.6 | NA | Median and upper 95% CI PFS was not reached due to the low number of progressions (5) |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper 95% CI PFS was not reached due to the low number of progressions (11)
- group Id
- OG000
- lower Limit
- 31.3
- upper Limit
- NA
- value
- NA
- comment
- Median and upper 95% CI PFS was not reached due to the low number of progressions (5)
- group Id
- OG001
- lower Limit
- 39.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 35
- units
- Participants
- description
- The distribution of PFS will be estimated using the method of Kaplan Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with multiple myeloma\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies\> \>\> \> \>\> Patient has multiple myeloma at baseline
- id
- OG000
- title
- Phase I/II, Cohort A
- description
- Patients with biopsy proven light chain amyloidosis with organ involvement requiring therapy\> \> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies\> \>\> \> \>\> Patient has light chain amyloidosis at baseline
- id
- OG001
- title
- Phase II, Cohort B
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice