NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"

Completed

• Conditions: Relapsed/Refractory Multiple Myeloma
• Interventions: Drug: Ixazomib

• Registration Number: NCT03169361
• Lead Sponsor: Takeda

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.

Detailed Description

The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

The study will enroll approximately 480 patients.

• Ixazomib 4 mg

This multi-center trial will be conducted in Japan.

Study Timeline

• Study Start: 2017-05-24
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Status Verified: 2023-03
• Results First Submitted: 2023-03-05
• Results First Submitted QC: 2023-03-05
• Last Update Submitted: 2023-03-05
• Results First Posted: 2023-12-07
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 774

Inclusion Criteria

• All patients who have been confirmed as administration of the drug.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ixazomib 4 mg	Ixazomib	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)	Up to 24 Week (From start of administration to the end of 6 cycles)	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.
Number of Participants Reporting One or More Adverse Events (AEs)	Up to 24 Week (From start of administration to the end of 6 cycles)	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.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan