A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
18 Years
N/A
Both
Multiple Myeloma
Trial Information
A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
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)
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.
Type of Study:
Observational [Patient Registry]
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Adverse Events
Outcome Description:
Number of participants with adverse events
Outcome Time Frame:
Up to two years
Safety Issue:
Yes
Principal Investigator
Ye Hua, MD
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
Taiwan : Food and Drug Administration
Study ID:
T-CC-5013-MM-009
NCT ID:
NCT01752075
Start Date:
January 2011
Completion Date:
September 2013
Related Keywords:
- Multiple Myeloma
- Multiple myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
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