A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)

Takeda191 enrolled

Overview

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.

This is a non-interventional, prospective, observational post-marketing surveillance study of ixazomib citrate in participants with MM. The study will assess the safety and effectiveness of ixazomib citrate for its approved indications in a clinical practice setting under real-world conditions. The study will enroll approximately 165 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group: • Participants With MM The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years and 11 months. Data will be collected over and up to a 6 months-surveillance period (per participant) once enrolled.

Study Type

OBSERVATIONAL

Enrollment

191

Conditions

Multiple Myeloma

Interventions

No InterventionOTHER

This is a non-interventional study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (20)

Hallym University Sacred Heart Hospital

Anyang, South Korea

SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon

Bucheon-si, South Korea

Outcomes

Primary Outcomes

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Up to 6 months

Secondary Outcomes

Progression-free Survival (PFS)

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.

Time frame: 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)

Overall Response Rate (ORR)

ORR is defined as the percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) based on the review of the myeloma response data assessed by IMWG criteria. sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hour; PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required.

Data from ClinicalTrials.gov

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