Multiple Myeloma

Patients with early NK/T cell lymphoma were treated with an oral regimen of \"Selinisol + pemaspartase + dexamethasone\"

Background: * Multiple myeloma (MM) is an incurable malignancy of plasma cells that leads to destructive bone lesions, renal damage, anemia, and hypercalcemia. MM is the second most common hematologic malignancy. The American Cancer Society estimates that annually over 34,000 new cases of MM will occur in the U.S. and over 12,000 deaths due to MM in 2022. * Overall survival (OS) has improved significantly over the past 20 years with the development of proteasome inhibitors (PIs), immunomodulatory agents (IMiDs) and anti-CD38 monoclonal antibodies. However, despite these advances, patients ultimately relapse requiring multiple subsequent lines of therapy. As MM evolves, it generally becomes more refractory, and patients ultimately succumb to their disease. * With multiple lines of efficacious therapies, the correct early identification of relapsed disease is important to trigger initiation of a new line of therapy. * Limitations in conventional imaging highlight a need for molecular imaging agents with better sensitivity for detecting and measuring tumor burden to improve staging and treatment selection for patients with MM and plasma cell dyscrasias. * 18F-fluciclovine is a radionuclide approved by the FDA for evaluating suspected prostate cancer recurrence but has shown additional ability in detecting MM lesions. Objective: To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma Eligibility: * Participants \>= 18 years old * Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2 * Participants must have a documented diagnosis of MM defined by the International Myeloma Working Group (IMWG) Criteria * Participants fit criteria for one of the following categories: * Newly diagnosed multiple myeloma (NDMM) without previous treatment (or within the first 3 cycles of front-line treatment) * Relapsed and/or Refractory multiple myeloma (RRMM) with at least 1 prior line of therapy Design: This is an open-label, single center phase 2 study evaluating 18F-fluciclovine PET/CT imaging in up to 50 participants with multiple myeloma. Participants will be enrolled into one of two cohorts based on disease status; newly diagnosed multiple myeloma (NDMM) participants will be enrolled into Cohort 1 and relapsed refractory multiple myeloma (RRMM) participants will be enrolled into Cohort 2. All subjects will undergo an 18F-fluciclovine injection followed by a static whole-body PET/CT at three time points: Timepoint #1, Timepoint #2 (after induction for NDMM or at 6 months for RRMM) and Timepoint #3 (at progression or at 5 years). Results will be compared to 18F-FDG PET/CT imaging at those same timepoints.

18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.

OBJECTIVES: Primary * Evaluate the use of 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) positron emission tomography (PET) imaging to measure tumor proliferation and the DNA synthetic pathway (thymidine kinase levels) in patients with cancer. Secondary * Determine the efficacy of FLT PET imaging in detecting lesions and estimating response to treatment. OUTLINE: Patients undergo up to four 3'-deoxy-3'-\[18F\] fluorothymidine positron emission tomography imaging procedures.

This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.

In Italy, myeloma accounts for 1.3% of all tumour diagnoses in males and for 1.2% of all tumour diagnoses in women. The incidence is 9.5 new cases per 100,000 males and 8.1 cases per 100,000 females. Median age at diagnosis is 68 years and approximately 2% of patients experience onset before the age of 4011. Therefore is to establish a national disease registry to monitor current routine clinical practice in Italy and to describe the standard of care adopted for the diagnosis and treatment of patients with myeloma. National registries have already been established in some countries and a recently-published meta-analysis highlighted certain differences in treatment, survival and the demographic characteristics of patients. An Italian national registry is important for analysing the current situation, in order to deal with the changes that lie ahead. In addition to the standard epidemiological registry - as described in the statistical methods section - a patientpowered registry (PPR) will also be established to encourage patient participation.

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

TQB2934 is an anti-Cluster of Differentiation 3 (CD3) (Early T Cell Marker)×B cell maturation antigen (BCMA) double-specific antibody，and the isoform is IgG1(Native Immunoglobulin G1), which at one end binds to the CD3 receptor on the surface of T cells ,and the other end binds to BCMA(B cell maturation antigen) to recruit T cells around BCMA-positive cells, which can activate T cells .Active T cells release granzyme and perforin to kill BCMA-positive target cells. TQB2934 for injection (subcutaneous injection) is intended for the treatment of patients with multiple myeloma.

This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study to compare SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression. This study consists of two stages. Stage 1 is the dose exploration stage to confirm the recommended stage 2 dose of SG301 injection in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the randomized controlled stage of SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.