TriangleNCT01415882 · OUTCOME
Event-free Survival
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
- From registration to disease progression while receiving ixazomib citrate and dexamethasone, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 2.5 years
What was measured
Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of dexamethasone. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.
Groups in this outcome
Arm A (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (Ixazomib Citrate and Dexamethasone)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A (Ixazomib Citrate and Dexamethasone) | 32 |
| Arm B (Ixazomib Citrate and Dexamethasone) | 35 |
| Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) | 35 |
| Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) | 33 |
| Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab) | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Ixazomib Citrate and Dexamethasone) | 11.5 | Not reported | 9.1 | 20.3 | Not reported |
| Arm B (Ixazomib Citrate and Dexamethasone) | 8.4 | Not reported | 4.5 | 12.8 | Not reported |
| Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) | 7.8 | Not reported | 4.6 | 11.9 | Not reported |
| Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) | 18.8 | Not reported | 10.2 | 30.4 | Not reported |
| Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab) | 29.5 | Not reported | 18.8 | 39.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.1
- upper Limit
- 20.3
- value
- 11.5
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- 12.8
- value
- 8.4
- group Id
- OG002
- lower Limit
- 4.6
- upper Limit
- 11.9
- value
- 7.8
- group Id
- OG003
- lower Limit
- 10.2
- upper Limit
- 30.4
- value
- 18.8
- group Id
- OG004
- lower Limit
- 18.8
- upper Limit
- 39.6
- value
- 29.5
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 33
- group Id
- OG004
- value
- 24
- units
- Participants
- description
- Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of dexamethasone. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm B (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From registration to disease progression while receiving ixazomib citrate and dexamethasone, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 2.5 years
- title
- Event-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice