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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With MM | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with MM who have been newly prescribed with ixazomib citrate in routine clinical practical setting will be observed prospectively.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | 14068 | South Korea | |||
| SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| 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. | Up to 6 months |
| Bucheon-si |
| 14584 |
| South Korea |
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Chungnam National Unversity Hospital | Daejeon | 35015 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | 58128 | South Korea |
| The Catholic University of Korea, Incheon ST. Marys Hospital | Incheon | 21431 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung medical center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Ewha womans university medical center | Seoul | 07985 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| Yongin Severance Hospital | Yongin | 16995 | South Korea |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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