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Completed

NCT Number: NCT01752075

A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan

The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a real-world setting (versus a clinical trial).

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Key information

About this study

The REVLIMID Registry is a prospective, multi-center, observational study. The registry will register 100 patients being prescribed REVLIMID in Taiwan during and patients will be followed for two years after the enrollment of the last patient.

Safety and efficacy data will be recorded in the registry monthly or bi-monthly. In accordance with the Risk Minimization Program for REVLIMID (RevAssure) a patient categorized as a woman of childbearing potential will be prescribed REVLIMID on a monthly basis, whereas women of non-childbearing potential and men will be allowed up to two months supply per prescription.

After entry of baseline data, the prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients 18 years of age or older
  • Patients that are being prescribed REVLIMID in combination with dexamethasone for the treatment of multiple myeloma and that have received at least one prior therapy
  • Patient must be willing and able to provide informed consent
  • Patients will be informed about the Registry and will have to sign a specific Registry Informed Consent Form
  • Be able to ask questions prior to signing the Subject Information and Consent Form
  • Be clearly informed that their involvement/participation in the registry is voluntary
  • Understand that their medical care will not be altered in any way by their participation in the registry

Exclusion criteria

  • A Patient who is unwilling or unable to provide informed consent will not be included.

Treatment and study plan

Revlimid

Drug

The prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI).

Other names: Lenalidomide, CC-5013

Primary outcomes

  1. Adverse Events

    Time frame: Up to two years

    Number of participants with adverse events

Secondary outcomes

  1. Efficacy

    Time frame: Up to two years

    Revlimid dosage, reason for Revlimid discontinuation

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 19, 2012
Registry last updated
Nov 18, 2019

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.