About the Study
This is a Phase 3 interventional clinical trial assessing the safety and efficacy of lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) for a duration of 12 years.
Learn moreCheck your eligibility now & get in touch with a study center
CHECK ELIGIBILITY
Who Can Join?
If you have been diagnosed with smoldering multiple myeloma in the last 5 years with characteristic biochemical tests as per International Myeloma Working Group [IMWG] criteria, you are eligible to join the study.
Learn moreHow Do I Join?
Please check your eligibility by taking the prescreener questionnaire. You can then select the study site nearest to your residence and connect up with the research team via email or phone. You can also fill out the contact form.
Learn moreOur Goals
The primary goals of the study are four fold. The study aims to achieve and measure some of these outcomes:
Safety
To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
Benefits
Demonstrate clinical benefit of isatuximab in combination with lenalidomide and dexamethasone on progression-free survival (PFS) prolongation
Overall response and survival
Assess overall response rate (ORR), duration of response (DOR), minimal residual disease (MRD) negativity, diagnostic (SLiM CRAB) progression or death
Treatment outcomes
To assess time to first-line treatment for multiple myeloma (MM), potential immunogenicity of isatuximab and impact of abnormal cytogenetic subtype on participant outcome.
How Do I Join?
01
Check Eligibility
Check your eligibility by taking up the eligibility test. Please answer the questions below and, if you pre-qualify you may enter your contact details. Check your eligibility by taking up the eligibility test. Please answer the questions below and, if you pre-qualify you may enter your contact details.
02
Contact a study site
If your answers indicate that the study may be right for you, and you select a study site, your contact information will be shared with that study doctor. We can then give you further information and answer any questions you may have. Contacting a study site does not mean you have to join the study.
03
Treatment Period
You will be asked to take the study drug or placebo tablets for 12 weeks. You will need to take them twice a day by mouth, with your morning and evening meals. This is in addition to your regular medical care.
04
Follow-up
You can expect to visit the study site about 10 times, with one follow-up telephone call.
Am I Eligible?
Check your eligibility
Take up this questionnaire to help us determine if you have symptoms that are common to this clinical study. If you have the common symptoms, you may be eligible to take part in the study.
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Multiple Myeloma Trial
Multiple myeloma is diagnosed in over 100,000 patients each year worldwide. The therapeutic armamentarium for myeloma now includes alkylating agents, corticosteroids, deacetylase inhibitors, immunomodulatory agents, monoclonal antibodies, and proteasome inhibitors and continues to evolve. Stop myeloma in its tracks, join our study!
Find a site near you
Are You a Researcher or a Doctor?
Use this form to contact the study team.