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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03001804
Enrollment
29
Registered
2016-12-23
Start date
2017-06-30
Completion date
2022-12-16
Last updated
2023-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Revlimid, Lenalidomide, Non-transplantable

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.

Interventions

None listed

Sponsors

Celgene
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients receiving dexamethasone after 6 months of treatmentup to 2 yearsNumber of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment

Secondary

MeasureTime frameDescription
Number of patients with Deep Venous Thrombosis (VTE) prophylaxisup to 2 yearsNumber of patients that receive VTE prophylaxis
Over all response rate (ORR)up to 2 yearsNumber of patients that achieve a response
Adverse Events (AEs)up to 2 yearsNumber of patients with an adverse events

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026