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

Sponsor

Takeda (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04840680

Collaborator

(none)

165

Enrollment

Locations

39.2

Anticipated Duration (Months)

7.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: No Intervention

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

165 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Post-Marketing Surveillance (Usage Results Study) of Ixazomib Citrate in Patients With Multiple Myeloma in South Korea

Actual Study Start Date :

Mar 22, 2021

Anticipated Primary Completion Date :

Jun 27, 2024

Anticipated Study Completion Date :

Jun 27, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: No Intervention This is a non-interventional study.

Arm

Intervention/Treatment

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.

Other: No Intervention

This is a non-interventional study.

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up to 6 months]

Secondary Outcome Measures

Progression-free Survival (PFS) [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)]
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.
Overall Response Rate (ORR) [Up to 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with MM.
Participants who are prescribed and initiate ixazomib citrate for the treatment of MM according to the ixazomib citrate South Korean product label.

Exclusion Criteria:

Participants treated with ixazomib citrate outside of the locally approved label in South Korea.
Participants for which ixazomib citrate is contraindicated as per product label.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hallym University Sacred Heart Hospital	Anyang	Korea, Republic of	14068
2	SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon	Bucheon	Korea, Republic of	14584
3	Inje University Busan Paik Hospital	Busan	Korea, Republic of	47392
4	Pusan National University Hospital	Busan	Korea, Republic of	49241
5	Kosin University Gospel Hospital	Busan	Korea, Republic of	49267
6	Kyungpook National University Hospital	Daegu	Korea, Republic of	41944
7	Keimyung University Dongsan Hospital	Daegu	Korea, Republic of	42601
8	Chungnam National Unversity Hospital	Daejeon	Korea, Republic of	35015
9	Chonnam National University Hwasun Hospital	Hwasun	Korea, Republic of	58128
10	The Catholic University of Korea, Incheon ST. Marys Hospital	Incheon	Korea, Republic of	21431
11	Korea University Anam Hospital	Seoul	Korea, Republic of	02841
12	Seoul National University Hospital	Seoul	Korea, Republic of	03080
13	Seoul National University Hospital	Seoul	Korea, Republic of	03080
14	Samsung medical center	Seoul	Korea, Republic of	06351
15	The Catholic University of Korea Seoul ST. Mary's Hospital	Seoul	Korea, Republic of	06591
16	Chung-Ang University Hospital	Seoul	Korea, Republic of	06973
17	Ewha womans university medical center	Seoul	Korea, Republic of	07985
18	Korea University Guro Hospital	Seoul	Korea, Republic of	08308
19	Ajou University Hospital	Suwon	Korea, Republic of	16499
20	Yonsei University Wonju Severance Christian Hospital	Wonju	Korea, Republic of	26426
21	Yongin Severance Hospital	Yongin	Korea, Republic of	16995

Sponsors and Collaborators

Takeda

Investigators

Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain more information on the study, click here/on this link

Publications

None provided.

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT04840680

Other Study ID Numbers:

C16030

First Posted:

Apr 12, 2021

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Takeda

Drug Therapy

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jun 21, 2022