View clinical trials related to Neoplasms, Plasma Cell.
Filter by:This phase I trial studies the side effects and how well CART-BCMA/CS1 works in treating patients with multiple myeloma (MM) that has come back (relapsed) or that does not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers, including MM. Immune cells can be engineered to kill MM cells by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells using a lentiviral vector, that allows them to recognize MM cells. CART-BCMA cells are such modified T cells that target markers called CS1 or B-cell maturation antigen (BCMA), which is expressed by a type of white blood cell called a "B-cell", which are cells that may help the MM cells grow. These engineered CART-BCMA/CS1 cells may kill MM cells.
This is a prospective, multicentre, phase III, randomised, controlled intervention study. Two groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). Each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). - PASCA interventional group For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary. - Control group For the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management. => For all patients, regardless of group All patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications: - Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and/or the start of his or her consolidation treatment. - Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment; - Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment; - Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.
A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg of Dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose
This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed T-cell engager (anti-BCMAxCD3 bispecific antibody), will be offered monitored drug discontinuation. Teclistamab is typically dosed on a regular schedule (every 1-4 weeks) indefinitely until disease progression ("continuous therapy"). Here, a limited-duration regimen will be studied in which patients achieving ≥VGPR after 6-9 months of standard teclistamab dosing will discontinue therapy and resume if laboratory or clinical parameters suggest early disease progression ("limited-duration therapy"). Patients will enter the clinical trial protocol after completing 6-9 months of standard teclistamab monotherapy and achieving ≥VGPR. The study's hypothesis is that the failure probability six months after stopping teclistamab in this patient population will be non-inferior compared to that of historical controls treated with continuous therapy. Reducing drug exposure may be beneficial by reducing risk of infection and reducing anti-BCMA selective pressure toward generation of BCMA-negative relapses. Analysis of minimal residual disease (MRD), tumor features, and bone marrow microenvironment parameters, which will be pursued as exploratory correlative analyses in this study, may identify factors that predict durable response to limited-duration therapy and thereby enable more precise selection of patients likely to benefit from this approach. A subset of patients will be enrolled on a biomarker study for analysis of these exploratory endpoints.
This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (MagnetisMM-3). The investigators will also use data from multiple real-world sources, representing the SOC in clinical practice. This study does not seek any participants for enrollment. The investigators will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the investigators to know how well elranatamab can be used for RRMM treatment.
The purpose of this study is to test the effectiveness of evidence-informed mobile apps, Myeloma Coach and CLL Coach. These apps have been developed to help manage the physical and emotional symptoms experienced by multiple myeloma and chronic lymphocytic leukemia survivors. This study hopes to determine if a mobile app is a useful tool to help people manage commonly reported symptoms related to Multiple Myeloma (MM) and chronic lymphocytic leukemia (CLL).
The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II dose (RP2D) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.
The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.
The purpose of this study is to characterize the safety of QLS32015 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS32015 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.