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

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ClinicalTrials.gov Identifier: NCT03001804
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
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 (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) and in the registered indication under practice conditions.

Condition or disease
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. 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
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019


Group/Cohort
Lenalidomide (Revlimid®) in combination with dexamethasone
Lenalidomide (Revlimid®) in combination with dexamethasone is indicated for the treatment of adult patients with untreated multiple myeloma, where stem cell transplantation cannot be performed.



Primary Outcome Measures :
  1. Number of patients receiving full dose of dexamethasone after 6 months [ Time Frame: up to 2 years ]
    Number of patients that receive dexamethasone


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001804


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Austria
KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie Recruiting
Linz, Austria, 4020
Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1 Recruiting
Ried, Austria, 4910
Landeskrankenhaus Steyr - Innere Medizin Active, not recruiting
Steyr, Austria, 4400
Innere Medizin I, Abteilung Hämatologie & Hämostaseologie Recruiting
Vienna, Austria, 1000 - 1901
St. Josef Krankenhaus Recruiting
Vienna, Austria, 1130
Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie Not yet recruiting
Vienna, Austria, 1160
Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin Active, not recruiting
Vöcklabruck, Austria, 4840
Sponsors and Collaborators
Celgene
Investigators
Study Director: Guenter Voraberger Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03001804     History of Changes
Other Study ID Numbers: CC-5013-MM-037
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Keywords provided by Celgene:
Multiple Myeloma
Revlimid
Lenalidomide
Non-transplantable

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents