NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
2 other identifiers
observational
774
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2017
CompletedStudy Start
First participant enrolled
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2022
CompletedResults Posted
Study results publicly available
December 7, 2023
CompletedDecember 7, 2023
March 1, 2023
4.8 years
May 24, 2017
March 5, 2023
March 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Reporting One or More Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to 24 Week (From start of administration to the end of 6 cycles)
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug.
Up to 24 Week (From start of administration to the end of 6 cycles)
Study Arms (1)
Ixazomib 4 mg
The usual adult dosage for oral administration is 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle will be repeated for 6 cycles. The dose may be reduced appropriately according to the patient's condition. Participants will receive interventions as part of routine medical care.
Interventions
Eligibility Criteria
The study population will consist of all participants with a diagnosis of multiple myeloma and received their first dose of NINLARO/lenalidomide, and dexamethasone.
You may qualify if:
- All patients who have been confirmed as administration of the drug.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda Selected Site
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2017
First Posted
May 30, 2017
Study Start
May 24, 2017
Primary Completion
March 8, 2022
Study Completion
March 8, 2022
Last Updated
December 7, 2023
Results First Posted
December 7, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- 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.
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.