A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant

Study Overview
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Brief Summary
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This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.

Official Title
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A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant (Transplant Noneligible [TNE])

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Revlimid (lenalidomide)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have understood and voluntarily signed the Informed Consent Form (ICF) Age ≥ 18 years at the time of signing the ICF Newly diagnosed with multiple myeloma Must not be eligible for transplant Will be treated with a first-line lenalidomide-containing or nonlenalidomide-containing regimen, or currently is being treated with a first-line regimen and has received less than 2 cycles. Exclusion Criteria: Prior treatment for Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line Multiple myeloma (MM) therapy. Prior treatment with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line MM therapy through clinical trial participation or patient access program Two or more complete cycles of first-line therapy or any agent considered to be a firstline MM therapy for newly diagnosed multiple myeloma (NDMM) treatment before study enrollment Refusal to participate in the Revlimid Transplant noneligible (TNE) Newly diagnosed multiple myeloma (NDMM) Post-authorization safety study (PASS) or current participation in the treatment phase of an interventional clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TNE NDMM patients treated with lenalidomide regimen<br>Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen containing lenalidomide | Drug: Revlimid (lenalidomide)<br>* Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice<br>|
| TNE NDMM patients treated with non-lenalidomide<br>Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide | Drug: Revlimid (lenalidomide)<br>* Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular events | Number of participants with cardiovascular adverse events | Approximately 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of renal impairment in NDMM patients | To document renal function among TNE NDMM patients treated with a first-line regimen | Approximately 8 years | 
| Incidence of infections in NDMM patients | To document the severity of infections among TNE NDMM patients treated with a first-line regimen. | Approximately 8 years | 
| Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen | Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies. | Approximately 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Non transplant eligible, Revlimid, PASS, Non-interventional, Lenalidomide