NCT02960555: Phase 2 - Isatuximab in Patients With High Risk Smoldering Plasma Cell Myeloma
Updated: May 23
Isatuximab in Treating Patients With High Risk Smoldering Plasma Cell Myeloma
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.
PRIMARY OBJECTIVE: I. To determine the rate of response according to the International Myeloma Working Group Criteria. SECONDARY OBJECTIVES: 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.
OUTLINE: 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.
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02960555
Official Title: Phase II Single Arm Trial of Isatuximab (SAR650984) in Patients With High Risk Smoldering Multiple Myeloma
First Posted : November 9, 2016
Click here for details on ClinicalTrials.gov
* Isatuximab (SARCLISA)
- New York: Memorial Sloan-Kettering Cancer Center New York
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
- Texas: The University of Texas MD Anderson Cancer Center Houston
United States, New York
United States, Texas