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

NCT ID: NCT01752075

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2013-07-19

Brief 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).

Detailed 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)

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

REVLIMID

Taiwanese patients treated with REVLIMID

Revlimid

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Lenalidomide; CC-5013

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ye Hua, MD

Role: STUDY_DIRECTOR

Celgene

Locations

NTUH

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

T-CC-5013-MM-009

Identifier Type: -

Identifier Source: org_study_id