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OpenTrials
Completed

NCT Number: NCT03001804

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landeskrankenhaus Kirchdorf, Kirchdorf, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of patients receiving dexamethasone after 6 months of treatment

    Time frame: 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 outcomes

  1. Number of patients with Deep Venous Thrombosis (VTE) prophylaxis

    Time frame: up to 2 years

    Number of patients that receive VTE prophylaxis

  2. Over all response rate (ORR)

    Time frame: up to 2 years

    Number of patients that achieve a response

  3. Adverse Events (AEs)

    Time frame: up to 2 years

    Number of patients with an adverse events

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2016
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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