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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1149

Last updated 2022-07-05

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Jinshu Cho · Celgene

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-10
Completion
2015-12-10

Countries

  • United States
  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921828 on ClinicalTrials.gov