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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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