Clinical trial NCT03001804: Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients
Official title: Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Revlimid
Lenalidomide
Non-transplantable
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for therapy of untreated multiple myeloma, where stem cell transplantation cannot be performed

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients receiving dexamethasone after 6 months of treatment
timeFrame: up to 2 years
Secondary outcomes:
measure: Number of patients with Deep Venous Thrombosis (VTE) prophylaxis
timeFrame: up to 2 years
measure: Over all response rate (ORR)
timeFrame: up to 2 years
measure: Adverse Events (AEs)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Kirchdorf
country: Austria
facility: Landeskrankenhaus Kirchdorf
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Linz
country: Austria
facility: Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Ried
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1
city: Steyr
country: Austria
facility: Landeskrankenhaus Steyr - Innere Medizin
city: Vienna
country: Austria
facility: Klinische Abteilung für Hämatologie und Hämostaseologie
city: Vienna
country: Austria
facility: St. Josef Krankenhaus
city: Vienna
country: Austria
facility: Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
city: Vöcklabruck
country: Austria
facility: Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin
city: Wien
country: Austria
facility: AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
city: Wr. Neustadt
country: Austria
facility: LKH Wiener Neustadt, Innere Medizin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: