TriangleNCT03457142 · OUTCOME
Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 1 cycle of 28 days
What was measured
Will be compared to historical controls of ixazomib citrate + dexamethasone. Responses to treatment will be measured by serum immunoglobulins, serum free kappa and lambda light chains, serum protein electrophoresis/immunofixation electrophoresis, and 24-hour urine protein electrophoresis/immunofixation. International uniform response criteria will be used. The anti-myeloma activity will be evaluated on an exploratory basis and will be summarized using descriptive statistics or graphical methods. No formal comparison will be carried forth.
Analysis population: 1 patient experienced death prior to disease response assessment.
Groups in this outcome
Treatment (Abatacept, Ixazomib Citrate, Dexamethasone)
Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 14 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 1 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 4 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 8 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Abatacept, Ixazomib Citrate, Dexamethasone) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 4
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 8
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 1
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Will be compared to historical controls of ixazomib citrate + dexamethasone. Responses to treatment will be measured by serum immunoglobulins, serum free kappa and lambda light chains, serum protein electrophoresis/immunofixation electrophoresis, and 24-hour urine protein electrophoresis/immunofixation. International uniform response criteria will be used. The anti-myeloma activity will be evaluated on an exploratory basis and will be summarized using descriptive statistics or graphical methods. No formal comparison will be carried forth.
- groups
- description
- Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abatacept: Given IV and SC Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies
- id
- OG000
- title
- Treatment (Abatacept, Ixazomib Citrate, Dexamethasone)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 1 patient experienced death prior to disease response assessment.
- reporting Status
- POSTED
- time Frame
- 1 cycle of 28 days
- title
- Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice