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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    888
  • sponsor
    Celgene
Updated on 26 March 2021
Investigator
Associate Director Clinical Trial Disclosure
Primary Contact
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord (0.5 mi away) Contact
+161 other location
cancer
lenalidomide
revlimid

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Revlimid (lenalidomide)
Clinical Study IdentifierNCT03106324
SponsorCelgene
Last Modified on26 March 2021

Eligibility

Yes No Not Sure

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
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