A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths). 2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).

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Key information

Conditions

Multiple Myeloma Agranulocytosis Arrhythmias, Cardiac Blood Platelet Disorders Blood Protein Disorders Cardiovascular Diseases Constipation Cytopenia Diarrhea Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity Immune System Diseases Immunoproliferative Disorders Infarction Infections Ischemia Kidney Diseases Leukocyte Disorders Leukopenia Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neuromuscular Diseases Neutropenia Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Renal Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive Teratogenesis Thrombocytopenia Thromboembolism Tumor Lysis Syndrome Urogenital Diseases Urologic Diseases Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shinko Hospital

Kobe, Hyōgo, 651-0072, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Exclusion criteria

N/A

Treatment and study plan

Primary outcomes

Adverse Events (AEs)

Time frame: 3 years

Number of participants with adverse events

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Oct 4, 2016
Registry last updated: Jun 14, 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