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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsed/Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Ixazomib

Drug

Ixazomib capsules

Other names: NINLARO capsules, MLN9708

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: May 30, 2017
Registry last updated: Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed