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

Takeda

Status: Completed

Conditions: Relapsed/Refractory Multiple Myeloma

Treatments: Drug: Ixazomib

Study type: Observational

Funder types: Industry

Identifiers

NCT03169361

JapicCTI-173592 (Registry Identifier)

C16025

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

Full 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.

Enrollment: 774 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

774 participants in 1 patient group

Ixazomib 4 mg

Description:

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.

Treatment:

Drug: Ixazomib