A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained. 2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

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Key information

Conditions

Multiple Myeloma Acute Kidney Injury Arrhythmias, Cardiac Blood Protein Disorders Cardiovascular Diseases Confusion Consciousness Disorders Digestive System Diseases Dizziness Embolism and Thrombosis Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hyperbilirubinemia Hypersensitivity Immune System Diseases Immunoproliferative Disorders Infections Jaundice Kidney Diseases Liver Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neuromuscular Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Renal Insufficiency Respiratory Tract Diseases Sensation Disorders Signs and Symptoms Skin Manifestations Sleepiness Teratogenesis Thromboembolism Tumor Lysis Syndrome Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shinko Hospital, Kobe, Hyōgo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Exclusion criteria

Treatment and study plan

Primary outcomes

Adverse event (AE)

Time frame: 3 years

Number of participants with adverse events

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Oct 3, 2016
Registry last updated: Jul 5, 2022

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