NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) “Relapsed/Refractory Multiple Myeloma”
Overview
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
Full Title of Study: “NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) “Relapsed/Refractory Multiple Myeloma””
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 8, 2022
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.
Interventions
- Drug: Ixazomib
- Ixazomib capsules
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
Primary Measures
- Number of Participants Reporting One or More Adverse Events (AEs)
- Time Frame: 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.
- Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
- Time Frame: 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.
Participating in This Clinical Trial
Inclusion Criteria
- All patients who have been confirmed as administration of the drug. Exclusion Criteria:
- None
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Takeda
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Study Director, Study Director, Takeda
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