TriangleNCT01864018 · OUTCOME
Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)
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 48 weeks
What was measured
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Analysis population: Includes only patients with biopsy proven light chain amyloidosis with organ involvement\>\> requiring therapy at baseline
Groups in this outcome
Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
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
| Group | Source count |
|---|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 63 | Not reported | 45 | 79 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45
- upper Limit
- 79
- value
- 63
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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
- id
- OG000
- title
- Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)
- param Type
- NUMBER
- population Description
- Includes only patients with biopsy proven light chain amyloidosis with organ involvement\>\> requiring therapy at baseline
- reporting Status
- POSTED
- time Frame
- Up to 48 weeks
- title
- Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice