This phase II trial tests how well isatuximab, dexamethasone and lenalidomide works in treating ultra-frail patients with multiple myeloma (MM). This study uses isatuximab in combination with low dose dexamethasone as a gentle approach to starting treatment for MM. Isatuximab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. Using a go-slow approach, with isatuximab with dexamethasone and lenalidomide, may help to treat MM by improving quality of life and may help ultra-frail patients stay on treatment longer.
Additional locations may be listed on ClinicalTrials.gov for NCT06517017.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Approved
Contact: Ghulam Rehman Mohy-ud-din
Phone: 801-585-2626
PRIMARY OBJECTIVE:
I. To assess the feasibility of approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of lenalidomide from the third cycle onwards in ultra-frail patients with myeloma.
SECONDARY OBJECTIVES:
I. To assess if an approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of a lenalidomide in ultra-frail patients with myeloma leads to an improvement in quality of life as measured by the European Organization for Research and Treatment of Cancer (EORTC) score.
II. To assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population.
III. To assess overall survival in this study population.
EXPLORATORY OBJECTIVE:
I. To compare the performance of different frailty scores in this patient population.
OUTLINE:
Patients receive isatuximab subcutaneously (SC) over 15 minutes and dexamethasone orally (PO) on days 1, 8, 15 and 22 of cycles 1-2 and days 1 and 15 of cycles 3+, as well as lenalidomide PO on days 1 - 21 of cycles 3+. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone may be discontinued after cycle 2 at the investigator’s discretion. Additionally, patients may undergo magnetic resonance imaging (MRI), positron emission tomography (PET) scan, computed tomography (CT) scan and/or skeletal survey during screening. Patients also undergo bone marrow biopsy and aspiration during screening and blood sample collection during screening and on study.
After completion of study treatment, patients are followed up at 30 days, and then every year for up to 3 years.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorGhulam Rehman Mohy-ud-din
