View clinical trials related to Multiple Myeloma.
Filter by:The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators. Safety refers to the measurement of: i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests). ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infections The study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study.
The clinical trial was designed as a single-arm, open-label clinical study, with the main purpose of exploring the safety, pharmacokinetics, and best recommended dose (RP2D) of the UTAA17 injection in the treatment of relapsed or refractory multiple myeloma (r/r MM) subjects, and also the efficacy will be observed. Eligible subjects will accept the infusion of UTAA17 injection after pretreatment, and their blood will be collected before and after infusion for evaluation of pharmacokinetics, immunogenicity and safety. This study plans to evaluate efficacy using the revised Evaluation of Efficacy in multiple myeloma -IMWG criteria (2016), which will be evaluated at 4w, 2m, 3m, 6m, and 6 to 24m (at a frequency of Q3m) after cell reinfusion, in addition to the baseline period. Efficacy evaluation continues until one of the following occurs: subject disease progression (PD), acceptance of a new antitumor therapy, death, occurrence of intolerable toxicity, investigator decision, or patient decision to withdraw.
This is an open-label clinical study to evaluate the efficacy and safety of a multicenter, open-label clinical study of a base-reduced-dose pomalidomide, cyclophosphamide combined with dexamethasone (PCd) regimen for the treatment of patients with debilitating relapsed refractory multiple myeloma. Subjects meeting the enrollment criteria were screened for entry into the study and treated with the appropriate regimen; all patients enrolled in the study did not receive medications other than those specified in the regimen for the treatment of myeloma during the study period, except for supportive care. The primary endpoint of the study is ORR; secondary study endpoints include efficacy above VGPR, progression-free survival (PFS), overall survival (OS), TTNT, safety, and life scale assessment.
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM
ENROL, the European Rare Blood Disorders Platform has been conceived in the core of ERN-EuroBloodNet as an umbrella for both new and already existing registries on Rare Hematological Diseases (RHDs). ENROL aims at avoiding fragmentation of data by promoting the standards for patient registries' interoperability released by the EU RD platform. ENROL's principle is to maximize public benefit from data on RHDs opened up through the platform with the only restriction needed to guarantee patient rights and confidentiality, in agreement with EU regulations for cross-border sharing of personal data. Accordingly, ENROL will map the EU-level demographics, survival rates, diagnosis methods, genetic information, main clinical manifestations, and treatments in order to obtain epidemiological figures and identify trial cohorts for basic and clinical research. To this aim, ENROL will connect and facilitate the upgrading of existing RHD registries, while promoting the building of new ones when / where lacking. Target-driven actions will be carried out in collaboration with EURORDIS for educating patients and families about the benefits of enrolment in such registries, including different cultural and linguistic strategies. The standardized collection and monitoring of disease-specific healthcare outcomes through the ENROL user-friendly platform will determine how specialized care is delivered, where are the gaps in diagnosis, care, or treatment and where best to allocate financial, technical, or human resources. Moreover, it will allow for promoting research, especially for those issues that remain unanswered or sub-optimally addressed by the scientific community; furthermore, it will allow promoting clinical trials for new drugs. ENROL will enable the generation of evidence for better healthcare for RHD patients in the EU as the ultimate goal. ENROL officially started on 1st June 2020 with a duration of 36 months. ENROL is co-funded by the Health Programme of the European Union under the call for proposals HP-PJ-2019 on Rare disease registries for the European Reference Networks. GA number 947670
To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma
This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples. This study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples
This qualitative study seeks to explore the unmet needs of individuals who have recently undergone a cancer diagnosis and completed the acute phase of treatment. The primary objective is to utilize the experiences of patients, caregivers, and stakeholders to enhance the aftercare provided to cancer survivors. By delving into patient perceptions regarding unmet needs in cancer aftercare, the study aims to identify areas for redesigning and improving services to minimize these needs and ultimately enhance patient outcomes. Importantly, the investigation incorporates insights from patients, their caregivers, and stakeholders. The research will employ qualitative methods, specifically focus groups and interviews, to gather comprehensive perspectives from individuals in the Ausl IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. Including patients with diverse cancer types is crucial for capturing a broad spectrum of experiences. During data collection, both focus group discussions and interviews will be recorded in audio format and transcribed verbatim. This meticulous approach ensures an accurate representation of participants' voices and experiences. The subsequent analysis will employ a combination of framework and thematic analysis to extract meaningful insights and synthesize the data effectively. The study's ultimate goal is to leverage the findings to optimize aftercare services for cancer survivors within the local context of Ausl IRCCS Reggio Emilia. By incorporating the perspectives of patients, caregivers, and stakeholders, the research aims to contribute valuable insights that can inform the redesign and improvement of aftercare services, ultimately benefitting cancer survivors in the region.
This study is a single-arm, open-lable, phase I/II study to evaluate the efficacy and safety of GC012F in subjects with relapsed/refractory multiple myeloma.
This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb/Ⅱ).