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

  • End date
    Mar 31, 2025
  • participants needed
  • sponsor
Updated on 26 March 2021


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note