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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752075
• Other study ID #: T-CC-5013-MM-009
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: July 19, 2013

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 19, 2013
• Est. primary completion date: July 12, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

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

Locations

Country	Name	City	State
Taiwan	NTUH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants with adverse events	Up to two years
Secondary	Efficacy	Revlimid dosage, reason for Revlimid discontinuation	Up to two years