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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01752075
First received: December 14, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Secondary Outcome Measures:
  • 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)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Taiwanese patients with relapsed/refractory multiple myeloma

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752075

Locations
Taiwan
NTUH
Taipei, Taiwan
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Ye Hua, MD Celgene Corporation
  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 July 29, 2014