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Trial record 58 of 854 for:    LENALIDOMIDE AND Angiogenesis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01752075
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

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).

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Revlimid

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)


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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
REVLIMID
Taiwanese patients treated with REVLIMID
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).
Other Names:
  • Lenalidomide
  • CC-5013




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to two years ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Up to two years ]
    Revlimid dosage, reason for Revlimid discontinuation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752075


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

Additional Information:

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Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01752075     History of Changes
Other Study ID Numbers: T-CC-5013-MM-009
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015
Keywords provided by Celgene ( Celgene Corporation ):
Multiple myeloma
Additional relevant MeSH terms:
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Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
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
Immunologic Factors
Physiological Effects of Drugs
Growth Substances
Growth Inhibitors
Antineoplastic Agents