This research is testing whether the investigational drug isatuximab is safe and effective
when used in combination with standard agents for the treatment of newly diagnosed multiple
This is a multi-center, single-arm, open-label, Phase 2 study in patients with newly
diagnosed multiple myeloma (NDMM) eligible for high dose therapy (HDT) and autologous stem
cell transplant (ASCT).
In this research study, investigators are evaluating whether isatuximab is safe and effective
in participants with newly diagnosed multiple myeloma when given in combination with
lenalidomide, bortezomib, and dexamethsone.
This research study involves administration of a four-drug chemotherapy regimen that
combines the Investigational drug isatuximab with a standard chemotherapy regimen
comprised of lenalidomide, bortezomib, and dexamethasone.
This 4-drug regimen is not considered standard of the treatment of newly diagnosed
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of an investigational drug or combination of drugs to learn whether the
drug works in treating a specific disease. "Investigational" means that the drug is being
The U.S. Food and Drug Administration (FDA) has approved lenalidomide, bortezomib, and
dexamethasone as treatment options for this disease but the combination of these agents with
isatuximab hasn't been approved.
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.
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