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

NCT01752075 | Completed

• 1 other identifier: T-CC-5013-MM-009
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Myeloma

Keywords

Multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of participants with adverse events

  Up to two years

Secondary Outcomes (1)

• Efficacy

  Up to two years

Study Arms (1)

REVLIMID

Taiwanese patients treated with REVLIMID

Drug: Revlimid

Interventions

Revlimid DRUG

The prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI).

Also known as: Lenalidomide, CC-5013

REVLIMID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Taiwanese patients with relapsed/refractory multiple myeloma

You may qualify if:

• 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

You may not qualify if:

• \- A Patient who is unwilling or unable to provide informed consent will not be included.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

NTUH

Taipei, Taiwan

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ye Hua, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 19, 2012
• Study Start: January 1, 2011
• Primary Completion: July 12, 2013
• Study Completion: July 19, 2013
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

TW (1)