TriangleNCT02516423 · OUTCOME
Changes in Minimal Residual Disease From Study Entry to the Completion of Adjuvant Treatment (Approximately Six Months Post-registration) and at 1 Year Post-registration
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- at 6 and 12 months post-registration
What was measured
MRD was part of a sub-study which required additional consent and funding. Samples were collected from consenting patients and shipped to Alliance Hematologic Malignancy for release to a central laboratory at the end of the study once funding was obtained.
Analysis population: All eligible patients. In this study, per protocol, flow cytometry was to be performed by the central lab; early study closure and subsequent lack of funding resulted in no samples being processed by the lab, and therefore minimal residual disease at 6 and 12 months post RT was not collected. Changes in minimal residual disease cannot be reported because minimum residual disease was not collected and will never be collected in the future.
Groups in this outcome
Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid
Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
Zoledronic Acid
Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
| Group | Source count |
|---|---|
| Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid | 0 |
| Zoledronic Acid | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- MRD was part of a sub-study which required additional consent and funding. Samples were collected from consenting patients and shipped to Alliance Hematologic Malignancy for release to a central laboratory at the end of the study once funding was obtained.
- groups
- description
- Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
- id
- OG000
- title
- Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid
- description
- Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
- id
- OG001
- title
- Zoledronic Acid
- population Description
- All eligible patients. In this study, per protocol, flow cytometry was to be performed by the central lab; early study closure and subsequent lack of funding resulted in no samples being processed by the lab, and therefore minimal residual disease at 6 and 12 months post RT was not collected. Changes in minimal residual disease cannot be reported because minimum residual disease was not collected and will never be collected in the future.
- reporting Status
- POSTED
- time Frame
- at 6 and 12 months post-registration
- title
- Changes in Minimal Residual Disease From Study Entry to the Completion of Adjuvant Treatment (Approximately Six Months Post-registration) and at 1 Year Post-registration
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice