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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02921828

Enrollment

1149

Registered

2016-10-03

Start date

2015-04-30

Completion date

2015-12-10

Last updated

2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame	Description
Adverse event (AE)	3 years	Number of participants with adverse events

Countries

Japan, United States

Outcome results