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NCT03001804 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03001804
Other study ID # CC-5013-MM-037
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2017
Est. completion date December 16, 2022

Study information
Verified date June 2023
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date December 16, 2022
Est. primary completion date December 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Landeskrankenhaus Kirchdorf Kirchdorf
Austria Klinikum Klagenfurt am Wörthersee Klagenfurt
Austria Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie Linz
Austria Ordensklinikum Linz GmbH Elisabethinen Linz
Austria Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1 Ried
Austria Landeskrankenhaus Steyr - Innere Medizin Steyr
Austria Klinische Abteilung für Hämatologie und Hämostaseologie Vienna
Austria St. Josef Krankenhaus Vienna
Austria Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie Vienna
Austria Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin Vöcklabruck
Austria AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie Wien
Austria LKH Wiener Neustadt, Innere Medizin Wr. Neustadt

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients receiving dexamethasone after 6 months of treatment Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment up to 2 years
Secondary Number of patients with Deep Venous Thrombosis (VTE) prophylaxis Number of patients that receive VTE prophylaxis up to 2 years
Secondary Over all response rate (ORR) Number of patients that achieve a response up to 2 years
Secondary Adverse Events (AEs) Number of patients with an adverse events up to 2 years
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