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Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)

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: NCT01947309
Recruitment Status : Terminated (Business Decision)
First Posted : September 20, 2013
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Revlimid (lenalidomide)

Detailed Description:

This registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take REVLIMID as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of REVLIMID treatment.

The registry will capture data from 600 patients being prescribed REVLIMID in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.

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Study Type : Observational
Actual Enrollment : 176 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China
Study Start Date : November 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Multiple Myeloma Patients Treated with Revlimid (lenalidomide)
Single Cohort of Multiple Myeloma Patients Treated with Revlimid
Drug: Revlimid (lenalidomide)
Revlimid (lenalidomide) as prescribed in usual clinical practice




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 2 years after enrollment of last patient ]
    Assessment of PFS using IMWG Uniform Response Criteria

  2. Response Rates [ Time Frame: 2 years after enrollment of last patient ]
    Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Two years after last patient enrolled ]
  2. Time to Response (TTR) and Duration of Response (DOR) [ Time Frame: Two years after last patient enrolled ]
  3. Duration of Treatment with Revlimid [ Time Frame: Two years after last patient enrolled. ]
    Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID

  4. Safety Profile of Revlimid [ Time Frame: Two years after last patient enrolled ]
    All Adverse Events (AEs) and occurrence of second primary malignancies (SPM)



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
Adult Chinese Patients with Multiple Myeloma Treated with Revlimid (Lenalidomide) in a Postmarketing setting
Criteria

Inclusion Criteria:

  • Must understand and voluntarily sign written informed consent At least 18 years old at the time of signing informed consent Diagnosed with Multiple Myeloma Must have received at least one prior Multiple Myeloma treatment at the time of signing informed consent

Exclusion Criteria:

  • None

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): NCT01947309


Locations
Show Show 17 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Yu (Flora) Yao, MD Celgene Pharmaceutical (Shanghai) Co. Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01947309    
Other Study ID Numbers: NIPMS-RV-CN-001
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Keywords provided by Celgene:
Revlimid, lenalidomide, multiple myeloma, PFS, Response Rates
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