Clinical trial · Observational
A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)
Post-Marketing Surveillance (Usage Results Study) of Ixazomib Citrate in Patients With Multiple Myeloma in South Korea
NCT04840680CI-TRIAL-00079100completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, people with MM will be treated with ixazomib citrate according to their clinic's standard practice. The main aim of the study is to check for side effects from ixazomib citrate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants With MM
- description
- Participants with MM who are newly prescribed and will start treatment with ixazomib citrate in a real-world clinical practice setting will be observed prospectively for up to 6 years 11 months.
- interventionNames
- Other: No Intervention
Primary outcomes (1)
- measure
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- timeFrame
- Up to 6 months
Secondary outcomes (2)
- measure
- Progression-free Survival (PFS)
- timeFrame
- From first administration of study drug to the date of disease progression or death due to any cause, whichever occurs first (up to 6 months)
- description
- PFS is defined as the estimated length of time since the start of treatment with ixazomib to disease progression (PD), study end or death, whichever occurs first. PFS will be assessed by International Myeloma Working Group (IMWG) Criteria, PD: increase of greater than or equal to (\>=) 25 percent (%) from lowest response value in any one or more of the following: serum M-component increase \>=0.5 gram per deciliter (g/dL) or urine M-component increase \>=200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (\>) 10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. PFS will be analyzed using Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Participants with MM. 2. Participants who are prescribed and initiate ixazomib citrate for the treatment of MM according to the ixazomib citrate South Korean product label. Exclusion Criteria: 1. Participants treated with ixazomib citrate outside of the locally approved label in South Korea. 2. Participants for which ixazomib citrate is contraindicated as per product label.
References
Publications (0)
Data not yet available
No reference posted for this study.