Clinical Research Directory

Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma

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.

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.

IASO104 for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

This study is a single-center, open-label, dose-exploration trial designed to evaluate the tolerability and safety of different doses of IASO104 in patients with relapsed/refractory plasma cell neoplasms, determine the recommended dose of IASO104, and assess its pharmacokinetic and pharmacodynamic characteristics. Additionally, the study will preliminarily observe the efficacy of the investigational drug in a small sample of subjects with relapsed/refractory multiple myeloma.

IASO206 in Patients With Relapsed/Refractory Multiple Myeloma

This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma

A Single-arm Single-center Trial of Bridging GPRC5D/CD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma

This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of GPRC5D/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).