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NCT06669247
This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined). This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much * How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects) * If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)
NCT07523555
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response. Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.
NCT06285318
The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
NCT07497165
Background: Multiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed/refractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting. Methods: This multicenter, single-arm, real-world observational study will enroll 48 patients aged 18-75 years with RRMM diagnosed according to revised IMWG criteria who have received at least one prior systemic treatment. Eligible patients must have an ECOG performance status of 0-3, adequate treatment compliance, and written informed consent. Key exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved prior treatment toxicity above grade 1; grade ≥2 peripheral neuropathy or grade 1 with pain; severe infection within 14 days; plasma cell leukemia; psychiatric disorders affecting compliance; pregnancy or lactation; recent other malignancies; hypersensitivity to study drugs; HIV infection; participation in another clinical trial within 30 days; or any condition deemed unsuitable by investigators. Endpoints: The primary endpoint is overall response rate (ORR) after four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), assessed according to revised IMWG criteria. Statistical Analysis: Continuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Normally distributed data will be analyzed using Student's t-test or ANOVA, while non-normally distributed data will use rank-sum tests. Categorical variables will be analyzed using chi-square or Fisher's exact tests, and ordinal variables by Ridit analysis or nonparametric tests. Survival outcomes including progression-free survival (PFS) and overall survival (OS) will be estimated using Kaplan-Meier analysis and compared by log-rank test. A two-sided P value \<0.05 will be considered statistically significant. Study Period: October 2025 to September 2027.
NCT04973605
The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal translocation t(11;14). The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.
NCT05862012
This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).
NCT07284758
This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).
NCT07458659
A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma.
NCT07333430
A Phase 1a/1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma.
NCT03590652
The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.
NCT06730256
A Clinical Study to Explore the Safety, Efficacy, and Cellular Metabolic Dynamics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia.
NCT07195617
This study is a single-arm, single-center clinical study, with the main purpose of IIT clinical trials to evaluate the safety and initial efficacy of BCMA-GPRC5DCAR-T cells in subjects with relapsed/refractory multiple myeloma (r/rMM). The dose of this study was set to 2.0×106/kg±50% CAR-T cells, and the infusion method was a single peripheral infusion. After the screening period (W-8\~D-8), blood collection period (W-8\~D-8), pretreatment period (D-7\~D-3), and pre-infusion evaluation (D-2\~D-1), subjects were subjected to infusion of CAR-T cells in D0. After administration, they were subjected to safety, effectiveness and other related examinations according to the follow-up plan. The subjects followed up until 2 years after cell re-infusion or the subject met the withdrawal treatment standards, whichever occurs first.
NCT05286229
Multiple myeloma (MM) is an incurable disease characterized by the growth of monoclonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease state of etentamig in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Two doses of ABBV-383 will be explored. Each treatment arm receives a different dose of ABBV-383 to determine a tolerable dose. Approximately 12 adult participants with R/R MM will be enrolled in the study in approximately 6 sites in Japan. Participants will receive intravenous (IV) Etentamig (ABBV-383) at two increasing doses in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and and monitoring of side effects.
NCT06508983
The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.
NCT04896658
Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma
NCT06888752
A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma.
NCT06659770
This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world.
NCT05880043
This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.
NCT06369935
This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data
NCT03473496
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, and several clinical trials have been reported in the treatment of multiple myeloma with CAR-T cells.