A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
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Purpose
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).
| Condition |
|---|
|
Multiple Myeloma |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan |
- Adverse Events [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]Number of participants with adverse events
- Efficacy [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]Revlimid dosage, reason for Revlimid discontinuation
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Taiwanese patients with relapsed/refractory multiple myeloma
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT01752075 History of Changes |
| Other Study ID Numbers: | T-CC-5013-MM-009 |
| Study First Received: | December 14, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | Taiwan : Food and Drug Administration |
Keywords provided by Celgene Corporation:
|
Multiple myeloma |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Lenalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013