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

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Revlimid (lenalidomide)

• Registration Number: NCT03106324
• Lead Sponsor: Celgene

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-29
• Study Start: 2017-03-31
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-15
• Primary Completion: 2025-10-19
• Study Completion: 2026-01-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 911

Inclusion Criteria

1. Must have understood and voluntarily signed the Informed Consent Form (ICF)
2. Age ≥ 18 years at the time of signing the ICF
3. Newly diagnosed with multiple myeloma
4. Must not be eligible for transplant
5. 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

1. 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.
2. 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
3. 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
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TNE NDMM patients treated with lenalidomide regimen	Revlimid (lenalidomide)	Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen containing lenalidomide
TNE NDMM patients treated with non-lenalidomide	Revlimid (lenalidomide)	Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide

Primary Outcome Measures

Name	Time	Method
Incidence of cardiovascular events	Approximately 8 years	Number of participants with cardiovascular adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (124)

Innsbruck University Hospital; 🇦🇹 Innsbruck, Austria

LKH Hochsteiermark; 🇦🇹 Leoben, Austria

University hospital St. Pölten; 🇦🇹 Polten, Austria

CHU Saint-Pierre; 🇧🇪 Bruxelles, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

CHU-Charleroi; 🇧🇪 Charleroi, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

AZ Groeninge; 🇧🇪 Kortijk, Belgium

CHR Citadelle Liège; 🇧🇪 Liege, Belgium

Ziekehuis Oost Limburg; 🇧🇪 Limburg, Belgium

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