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NCT Number: NCT03106324

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck University Hospital, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revlimid (Lenalidomide)

Drug

Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice

Primary outcomes

  1. Incidence of cardiovascular events

    Time frame: Approximately 8 years

    Number of participants with cardiovascular adverse events

Secondary outcomes

  1. Incidence of renal impairment in NDMM patients

    Time frame: Approximately 8 years

    To document renal function among TNE NDMM patients treated with a first-line regimen

  2. Incidence of infections in NDMM patients

    Time frame: Approximately 8 years

    To document the severity of infections among TNE NDMM patients treated with a first-line regimen.

  3. Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen

    Time frame: Approximately 8 years

    Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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])

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2017
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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