This phase II trial studies how well isatuximab works in treating patients with high risk
smoldering plasma cell myeloma. Immunotherapy with monoclonal antibodies, such as isatuximab,
may induce changes in the body's immune system and may interfere with the ability of the
tumor cells to grow and spread.
I. To determine the rate of response according to the International Myeloma Working Group
I. To determine progression free survival (PFS) at 2 years. II. To determine overall survival
(OS). III. To determine duration of response (DOR). IV. To determine the clinical benefit
rate (CBR). V. To evaluate safety of single agent treatment in this population. VI. To
evaluate the immunogenicity of isatuximab.
Patients receive isatuximab intravenously (IV) over 5 hours on day 1 of cycle 1, and over 3
hours thereafter on days 8, 15, and 22 of cycle 1, on days 1 and 15 of cycles 2-6, and on day
1 of subsequent cycles. Treatment repeats every 28 days for up to 30 cycles in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-12 months.
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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