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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma

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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Austria
  • Kirchdorf, Austria, 4560
    • Landeskrankenhaus Kirchdorf
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee
  • Linz, Austria, 4020
    • Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH Elisabethinen
  • Ried, Austria, 4910
    • Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1
  • Steyr, Austria, 4400
    • Landeskrankenhaus Steyr - Innere Medizin
  • Vienna, Austria, 1090
    • Klinische Abteilung für Hämatologie und Hämostaseologie
  • Vienna, Austria, 1130
    • St. Josef Krankenhaus
  • Vienna, Austria, 1160
    • Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
  • Vöcklabruck, Austria, 4840
    • Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin
  • Wien, Austria, 1090
    • AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
  • Wr. Neustadt, Austria, 2700
    • LKH Wiener Neustadt, Innere Medizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients scheduled for therapy of untreated multiple myeloma, where stem cell transplantation cannot be performed

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort A; Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity
Cohort B; Initial treatment (up to 8 cycles): Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsule by mouth (PO) on day 1 through 14 of a 21 day cycle, Bortezomib 1.3mg/m2 s.c. on day 1, 4, 8, and 11 of a 21 day cycle, and Dexamethasone 20mg PO on days 1,2,4,5,8,9,11,12 of a 21 day cycle; Successive Treatment: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Deep Venous Thrombosis (VTE) prophylaxis	Number of patients that receive VTE prophylaxis	up to 2 years
Over all response rate (ORR)	Number of patients that achieve a response	up to 2 years
Adverse Events (AEs)	Number of patients with an adverse events	up to 2 years

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimated): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Lenalidomide; Revlimid; Non-transplantable
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CC-5013-MM-037