Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-06 @ 6:51 AM
Study NCT ID:
NCT03001804
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2016-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: