Multiple Myeloma

This research aims to evaluate the effectiveness and safety of a combination treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NK/T-cell lymphoma. The study is designed as a Phase 1 and Phase 2 clinical trial and focuses on improving local disease control and overall prognosis in this specific type of lymphoma. Patients receive an oral regimen combining Selinexor, Pegaspargase, and Dexamethasone. Selinexor works by inhibiting nuclear export proteins that are overexpressed in malignant tumor cells, including viral mRNA such as EBV. This treatment is combined with sequential radiotherapy to potentially enhance outcomes. The study monitors the responses to this combined therapy in early-stage lymphoma. Participants will be involved in regular assessments to track tumor response and overall health. The primary outcome measured is the complete response rate (CRR) based on tumor volume reduction, evaluated up to 36 months from randomization. Safety and treatment effects will be closely monitored during the trial period, which runs from September 2024 through December 2026.

Multiple myeloma (MM) is a cancer of plasma cells that currently has no cure and often returns after treatment. Survival after diagnosis is typically 5 to 8 years. Researchers are evaluating whether the radiotracer 18F-fluciclovine, injected during PET/CT scans, is better at detecting MM than the commonly used 18F-FDG tracer, aiming to improve early detection and treatment decisions. This is a phase 2, open-label study involving adults with newly diagnosed or relapsed/refractory MM. Participants will receive an intravenous injection of 18F-fluciclovine (370 MBq) and undergo PET/CT scans at three key times: before treatment or early in treatment (newly diagnosed MM), six months after initial scans (relapsed/refractory MM), and either at disease progression or after 5 years. Each visit includes both 18F-fluciclovine and 18F-FDG PET/CT scans, an optional MRI, and a bone marrow biopsy from the hip. The study compares the effectiveness of these imaging methods in detecting MM. During the study, participants will have three visits for imaging and biopsies, with tests spread over about 30 days per visit. Blood tests, disease volume measurements, and bone marrow analysis will be performed to assess disease status and treatment response. Safety of 18F-fluciclovine will be monitored up to three days after each dose. Follow-up includes a final visit after 5 years or upon disease progression, allowing long-term monitoring of MM status.

Researchers are evaluating the use of 18F-Pentixafor PET imaging to improve the diagnosis, staging, and response evaluation of hematological malignancies such as multiple myeloma, leukemia, and lymphoma. This imaging method targets the CXCR-4 receptor, which is overexpressed in these tumors and is linked to tumor growth and poor prognosis. The study aims to assess how well 18F-Pentixafor PET performs compared to current imaging methods like 18F-FDG PET. Participants will receive a single intravenous injection of 18F-Pentixafor at a dose of 55 MBq/kg. After 60 minutes, they will undergo either a PET/CT or PET/MR scan. This process allows for detailed imaging without special preparation. The study includes patients with suspected or confirmed hematological malignancies and involves only one imaging session per participant. During the study, researchers will monitor diagnostic accuracy and compare 18F-Pentixafor PET's performance with traditional 18F-FDG PET imaging. They will also assess disease activity using the Deauville Score over a period of up to 3-4 years. Participants will be involved in imaging procedures and may undergo biopsies if needed for diagnosis. The study will continue until December 2029, with an average follow-up of about 1.5 years for primary outcome assessment.

Researchers are studying the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging in patients with cancer. This phase I trial aims to evaluate how well FLT PET imaging measures tumor growth and the activity of the DNA synthetic pathway in various cancers, including solid tumors and blood cancers. The study also seeks to determine how effective this imaging method is at detecting lesions and assessing response to treatment. Participants receive up to four FLT PET imaging procedures. During each procedure, a small amount of the FLT tracer compound is injected into the vein, followed by PET scan data collection for two hours to measure tumor growth. Blood samples may be taken during the scans, and urine samples collected afterward to analyze breakdown products of the tracer. Throughout the study, patients undergo assessments including PET or CT PET scans to measure tracer uptake and retention in tumors and normal organs. Researchers also evaluate changes in key enzymes related to DNA synthesis before and after therapy. These evaluations help monitor tumor activity and treatment response. The total time participants spend in the scanner during imaging is up to two hours per session, with a focus on capturing detailed tumor growth information.

Researchers are evaluating a new formulation of 64Cu-LLP2A, a drug used with PET/CT imaging, to study its dosimetry and imaging quality in healthy volunteers and patients with certain blood cancers. These cancers include multiple myeloma and various low-grade lymphomas. This early phase 1 study aims to confirm that the new formulation provides similar human dosimetry to previously published results and to expand evaluation to patients with confirmed diagnoses or those post bone marrow transplant with suspected recurrence. Participants will receive 64Cu-LLP2A followed by PET/CT imaging at up to three separate times depending on the injection day of the week. Imaging sessions involve multiple quick body scans within the first hour, additional scans between 120 to 240 minutes, and a later scan 15 to 28 hours post injection. Patients with known lesions will have dynamic imaging centered over those areas for one hour, plus an additional scan from head to upper thigh after injection. During the study, participants will undergo PET/CT scans and monitoring of organ dosimetry and safety for up to seven days after 64Cu-LLP2A administration. Researchers will assess the quality of PET images by looking at bone marrow uptake and tumor-to-background ratios. Safety will be tracked by recording any adverse events. The total imaging and evaluation period is estimated to last up to two days, with additional follow-up phone assessments.

This observational study aims to create a national registry in Italy for multiple myeloma to monitor routine clinical practice and describe the standard care used for diagnosis and treatment. Multiple myeloma accounts for a small percentage of tumor diagnoses in Italy, with incidence rates of 9.5 per 100,000 males and 8.1 per 100,000 females. The registry will help analyze current treatment patterns and patient demographics to address future changes in care. The study involves a non-interventional, multicenter registry collecting both retrospective and prospective data from patients diagnosed with multiple myeloma since January 1, 2019. Data will be gathered using an electronic platform, and patients will be enrolled consecutively during their regular appointments after providing informed consent. Patients participating in other studies can also be included, with baseline and survival data collected for those in interventional trials. Participants will have hospital visits every six months, where clinical data and patient-reported outcomes will be recorded. Researchers will assess overall survival and time to next treatment over three years, along with patient-reported outcomes and costs incurred by patients. The study provides long-term monitoring without altering patients' usual care, and participation duration may vary depending on individual follow-up.

Researchers are evaluating the safety and effectiveness of BCMA-targeted prime CAR-T cell therapy in patients with relapsed or refractory Multiple Myeloma and other plasma cell diseases. This study focuses on patients who have limited treatment options and aims to assess adverse events and disease response after receiving this targeted therapy. Participants will receive a single treatment of BCMA-targeted prime CAR-T cells designed to attack myeloma cells expressing BCMA. The study includes Phase 1 and Phase 2 components and monitors patients for up to two years to evaluate treatment response and safety. During the study, participants will undergo regular assessments including monitoring of adverse events, disease status, levels of BCMA-targeted CAR-T cells in blood and bone marrow, clonal plasma cell quantities, serum IL-6 levels, and survival outcomes. The total follow-up duration for outcome measurement is up to two years to observe treatment effects and patient safety over time.

Researchers are evaluating TQB2934, a special antibody designed to target multiple myeloma, a cancer affecting plasma cells. This antibody binds to T cells and cancer cells to activate the immune system to attack the disease. The study is a Phase 1 clinical trial focusing on safety and the body's handling of the drug in patients with malignant plasma cell tumors. The study involves giving TQB2934 as a subcutaneous injection at doses of 40mg or 60mg. Treatment cycles occur once weekly during the first three cycles, then every two weeks for cycles four to six. If patients achieve a partial remission or better after six cycles, dosing continues every four weeks. Each treatment cycle lasts 28 days. Participants will undergo various assessments including blood tests to measure drug levels and immune response over 120 hours after each dose. Researchers will monitor adverse events for up to 24 months and evaluate treatment responses such as remission rates and survival outcomes. The total study participation includes treatment and long-term safety follow-up lasting up to two years.

Researchers are evaluating the effects of adding SG301 injection to the combination of pomalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma. This phase III, randomized, placebo-controlled, double-blind, multicenter study involves patients who have previously received treatments including lenalidomide and a proteasome inhibitor and have shown disease progression. The trial aims to confirm a recommended dose and compare treatment outcomes between the SG301 combination and placebo groups. Participants receive either SG301 injection or a placebo alongside pomalidomide and dexamethasone. SG301 and its placebo are given intravenously weekly for 8 weeks, then every two weeks afterward. Pomalidomide is taken orally daily on days 1 through 21 of each 28-day cycle, while dexamethasone is taken orally or intravenously on days 1, 8, 15, and 22 of each cycle, with dose adjustments for low body mass index. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. During the study, participants undergo regular evaluations including safety monitoring for adverse events, pharmacokinetic assessments, and disease progression checks using established criteria. Outcome measures include progression-free survival, overall response rate, duration of response, overall survival, and minimal residual disease status. Assessments occur up to approximately four years, with follow-up visits every 4 to 8 weeks, depending on study stage and timing. Participants are closely monitored to ensure safety and treatment adherence throughout their involvement.

Researchers are evaluating the safety and effectiveness of an investigational treatment called RN1101, which are allogeneic CAR-T cells targeting CD19 and BCMA. This early-phase, open-label pilot study focuses on patients with relapsed or refractory B-cell or plasma cell-derived malignant tumors, including B-cell lymphoma and multiple myeloma. The study plans to enroll 21 patients to understand how well this treatment works and its safety profile for these challenging cancers. Participants will receive a single intravenous infusion of RN1101 cells designed to target and attack cancerous B cells or plasma cells. The study involves a dose-escalation approach where all patients receive the experimental therapy. Researchers will monitor the treatment's ability to reduce or eliminate cancer cells expressing CD19 or BCMA and evaluate how long these CAR-T cells persist in the body. Throughout the study, participants will be closely followed for up to 24 weeks after the infusion. Researchers will assess safety by tracking adverse events and measure effectiveness using outcomes such as minimal residual disease status, response rates, progression-free survival, overall survival, and CAR-T cell presence in blood and bone marrow. Blood tests, imaging, and clinical evaluations will be performed regularly to monitor treatment response and participant health over this period.