Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients
- Conditions
- Multiple Myeloma
- Registration Number
- NCT03001804
- Lead Sponsor
- Celgene
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- Pregnant and lactating females
- No other formal exclusion criteria according to most recent European Summary of Product Characteristics (SmPC)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients receiving dexamethasone after 6 months of treatment up to 2 years Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment
- Secondary Outcome Measures
Name Time Method Over all response rate (ORR) up to 2 years Number of patients that achieve a response
Number of patients with Deep Venous Thrombosis (VTE) prophylaxis up to 2 years Number of patients that receive VTE prophylaxis
Adverse Events (AEs) up to 2 years Number of patients with an adverse events
Trial Locations
- Locations (12)
Landeskrankenhaus Kirchdorf
🇦🇹Kirchdorf, Austria
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt, Austria
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Austria
Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
🇦🇹Linz, Austria
Landeskrankenhaus Steyr - Innere Medizin
🇦🇹Steyr, Austria
Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1
🇦🇹Ried, Austria
AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
🇦🇹Wien, Austria
Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin
🇦🇹Vöcklabruck, Austria
LKH Wiener Neustadt, Innere Medizin
🇦🇹Wr. Neustadt, Austria
Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
🇦🇹Vienna, Austria
Klinische Abteilung für Hämatologie und Hämostaseologie
🇦🇹Vienna, Austria
St. Josef Krankenhaus
🇦🇹Vienna, Austria