Use Lenalidomide (Revlimid ) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients

  • STATUS
    Recruiting
  • days left to enroll
    23
  • participants needed
    112
  • sponsor
    Celgene
Updated on 26 January 2021
cell transplantation
dexamethasone
lenalidomide
revlimid

Summary

The aim of this non-interventional study is to collect primarily the percentage of patients who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15 and 22 of the repetitive 28-day cycles, 20 mg in >75 year old patients) in the registered indication under practice conditions.

Description

Multiple myeloma is still a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but incurable disease. On average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant. In February 2015 REVLIMID (lenalidomide) was approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Furthermore, in May 2019 REVLIMID was approved in combination with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Looking in more detail at the combination of lenalidomide and dexamethasone, the role and especially the most adequate and effective dosage of dexamethasone in long term use with lenalidomide is not clearly defined or well characterised It is therefore of great relevance to gain insights into the clinical practice and the routine of dexamethasone management and dosing in long term use with Revlimid.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Clinical Study IdentifierNCT03001804
SponsorCelgene
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Informed Consent
Age 18 years
Newly diagnosed Multiple Myeloma
Not suitable for stem cell transplantation
Appropriate methods of contraception according to the Risk Minimization Program (RMP)
Adequate thrombosis prophylaxis

Exclusion Criteria

Pregnant and lactating females
No other formal exclusion criteria according to most recent European Summary of Product Characteristics (SmPC)
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