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

NCT02921828 | Completed

• 1 other identifier: NIS-Celgene-JP-PMS-002
• Study Type: observational
• Target: 1,149
• Locations: 2 countries
• Sites: 2

Brief Summary

1. 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. 2.Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

Conditions

Multiple Myeloma

Keywords

Pomalyst; Teratogenicity; bone marrow suppression; thromboembolism; peripheral neuropathy; infection; tumour lysis syndrome; somnolence; depressed level of consciousness; confusion; fatigue; dizziness; acute renal failure; heart failure; arrhythmia; interstitial pneumonia; hypersensitivity; hepatic function disorder; jaundice

Outcome Measures

Primary Outcomes (1)

• Adverse event (AE)

  Number of participants with adverse events

  3 years

Study Arms (1)

Multiple myeloma patients who received Pomalyst

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Celgene: lead

Study Sites (2)

Local Institution - Japan

No City Provided, New Jersey, 00000, United States

Location

Shinko Hospital

Kobe, Hyōgo, 651-0072, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma; Teratogenesis; Thromboembolism; Peripheral Nervous System Diseases; Infections; Tumor Lysis Syndrome; Sleepiness; Consciousness Disorders; Confusion; Fatigue; Dizziness; Acute Kidney Injury; Heart Failure; Arrhythmias, Cardiac; Lung Diseases, Interstitial; Hypersensitivity; Liver Diseases; Jaundice

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Neuromuscular Diseases; Nervous System Diseases; Lymphatic Diseases; Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Neurocognitive Disorders; Mental Disorders; Sensation Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Lung Diseases; Respiratory Tract Diseases; Digestive System Diseases; Hyperbilirubinemia; Skin Manifestations

Study Officials

• Jinshu Cho

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 3, 2016
• Study Start: April 30, 2015
• Primary Completion: December 10, 2015
• Study Completion: December 10, 2015
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

JP (1); US (1)