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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