Clinical Trials Using Isatuximab
Clinical trials are research studies that involve people. The clinical trials on this list are studying Isatuximab. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
A phase Ib / II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.
Location: 8 locations
Carfilzomib, Lenalidomide, Dexamethasone, and Isatuximab for the Treatment of Newly Diagnosed, Transplant-Eligible Multiple Myeloma
This phase II trial investigates how well carfilzomib, lenalidomide, dexamethasone, and isatuximab work in treating patients with newly diagnosed multiple myeloma who are eligible for a transplant. Carfilzomib may work by inhibiting (blocking) multiple myeloma cells from breaking down proteins within the cells, causing a buildup of proteins within multiple myeloma cells, that may lead to cell death. Lenalidomide may work in many ways of attacking tumor cells including activating the immune system against the tumor, and increasing tumor cell death, and decreasing tumor blood vessel growth. Anti-inflammatory drugs, such as dexamethasone lower the body’s immune response and are used with other drugs to treat and kill some types of cancer. Isatuximab is a monoclonal antibody. An antibody is a protein produced in the blood to fight diseases by attacking and killing harmful foreign organisms such as bacteria and viruses. In some diseases, like cancer, the antibody will protect the patient by attaching itself to a target molecule inside the body, which is also a protein. Isatuximab will attach itself to a protein called CD38 located on the surface of immune cells and some cancer cells in the body and can induce the killing of those cells. Giving carfilzomib, lenalidomide, dexamethasone, and isatuximab may help treat patients with multiple myeloma.
Location: 4 locations
Isatuximab and Carfilzomib with or without Dexamethasone and Lenalidomide in Treating Patients with Relapsed or Refractory Multiple Myeloma
This phase Ib trial studies the side effects and best dose of isatuximab when given together with carfilzomib with or without dexamethasone and lenalidomide in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) or has not respond to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as isatuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving isatuximab and carfilzomib with or without dexamethasone and lenalidomide may be a better treatment for patients with multiple myeloma.
Location: 3 locations
Multi-center, Open-label, Phase 1b Study in Patients With Relapsed / Refractory Multiple Myeloma (RRMM)
Primary Objectives: - To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) - To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: - To estimate absolute bioavailability of SC and IV isatuximab - To measure receptor occupancy (RO) after isatuximab SC versus IV administration - To assess efficacy of isatuximab after SC and IV administration - To assess patient expectations prior to and patient experience and satisfaction after SC administration - To evaluate potential immunogenicity of SC or IV isatuximab
Location: 2 locations
Isatuximab, Bendamustine, and Prednisone for the Treatment of Refractory Multiple Myeloma
This trial studies the side effects and best dose of bendamustine and how well it works when given together with isatuximab and prednisone for the treatment of multiple myeloma that does not respond to treatment (refractory). Immunotherapy with isatuximab, may induce changes in body’s immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. Giving isatuximab, bendamustine, and prednisone may work better in treating patients with multiple myeloma compared to chemotherapy alone.
Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Primary Objective: To evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed / Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: - Safety and tolerability assessments - Assessment of infusion reactions (IRs) - Pharmacokinetics (PK) of isatuximab - Minimal residual disease - Overall response rate - Overall survival - Event free survival - Duration of response - Relationship between clinical effects and CD38 receptor density and occupancy
Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and / or Refractory Multiple Myeloma (RRMM)
Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are initiated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable
Location: UCSF Medical Center-Parnassus, San Francisco, California