Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients...
Newly Diagnosed Multiple MyelomaMultiple myeloma (MM) is a malignant disease of the BM characterized by clonal expansion of plasma cells. Current guidelines recommend that newly diagnosed transplant-eligible patients with multiple myeloma (NDMMTE) shall undergo several cycles of induction, followed by one or two cycles high-dose melphalan followed by autologous stem cell transfusion (ASCT). Currently, induction therapy schemes usually consist of an immunomodulator (thalidomide or lenalidomide), a transmembrane glycoprotein CD38 targeting antibody, a proteasome inhibitor, and dexamethasone. The induction therapy is then followed by stem cell mobilization and subsequently one or two cycles of high-dose melphalan-chemotherapy based on the initial cytogenetic findings of the malignant plasma cells and the initial stage of the disease. Essentially, all NDMMTE patients undergo at least one cycle of high-dose chemotherapy, which is associated with high morbidity including acute toxicities like cytopenia, infection, and long-term effects such as myelodysplastic disease (MDS) and secondary malignancies and rarely death. Based on preliminary data and published reports, exposure to high-doses of the genotoxic agent melphalan might render the residual malignant myeloma cells into more aggressive clones, accelerating relapse by potentially altering stroma. Finally, exposure to melphalan is well known to increase the possibility of secondary malignant disease development. In MM patients, high-dose melphalan therapy improves OS and PFS if patients from all risk groups are taken in consideration. Yet, it remains to be answered, whether also low risk patients have an additional benefit from high-dose melphalan therapy or whether for these patients, a less toxic regime would be similarly sufficient with regard to PFS and OS. The challenging question will be whether the effect of melphalan on initial disease control might be outpaced by the negative effects as described above. Hence, the sponsor will explore whether treatment with high-dose melphalan might represent an overtreatment for certain subpopulation myeloma patients. These patients might be adequately treated without need of high-dose melphalan as part of the first line treatment. The sponsor, therefore, proposes to use a personalized approach to evaluate whether patients with a low-risk profile and with a gene expression profile indicating a standard risk of relapse might be sufficiently treated with an intensified induction course without subsequent upfront high-dose melphalan chemotherapy.
CAR- PRISM (PRecision Intervention Smoldering Myeloma)
Multiple MyelomaSmoldering Multiple MyelomaThe goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: Cilta-cel (or chimeric antigen receptor T cells) Cyclophosphamide (a lymphodepleting chemotherapy) Fludarabine (a lymphodepleting chemotherapy)
Study of CT071 Injection in RRMM or PPCL
Multiple MyelomaPrimary Plasma Cell LeukemiaA Clinical Trial to Explore the Safety and Efficacy of CT071 injection in Patients with Relapsed/Refractory Multiple Myeloma or Primary Plasma Cell Leukemia
A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory...
Relapsed/ Refractory Multiple MyelomaThis trial is a phase 1b/2, open-label, multicenter study of GC012F, a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma
Relapsed or Refractory Multiple MyelomaThe purpose of this study is to characterize the safety of QLS32015 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS32015 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by BCMA CAR-T Therapy in Transplant-Ineligible...
Multiple MyelomaThis is a single-arm, open-label study to evaluate the efficacy and safety of VRD(Bortezomib, Lenalidomide and Dexamethasone) regimen combined with BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or...
Relapsed or Refractory Multiple MyelomaThe purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive...
HIVOrgan Transplantation5 moreDespite the greater risk of adverse COVID-19 outcomes, antibody and cell-mediated immune responses to COVID-19 vaccines vary amongst immunocompromised (IC) people and are poorly defined. IC hosts were largely excluded from the COVID-19 vaccine registration trials, though many countries recommend additional and booster doses of vaccination in this group. BOOST-IC is an adaptive randomised clinical trial (RCT) to assess the immunogenicity and safety of additional COVID-19 vaccine doses in immunocompromised (IC) people, including people with HIV, solid organ transplants (SOT) recipients or those with haematological malignancies. Briefly, the study aims to generate high-quality evidence on the immunogenicity and safety of alternative COVID-19 booster strategies against SARS-CoV-2 for IC people in Australia.
A Study of Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in People With...
Multiple MyelomaThe purpose of this study is to find out whether combination treatment with the study drugs belantamab mafodotin, nirogacestat, and pomalidomide is a safe treatment for people who have relapsed or refractory multiple myeloma. The researchers will test different doses of belantamab mafodotin to find the safest dose to give with nirogacestat and pomalidomide. The researchers also want to find out whether belantamab mafodotin plus nirogacestat and pomalidomide is an effective treatment for this type of bone marrow cancer, and the researchers will do tests that show whether the study treatment slows or stops the growth of cancer.
CAR-T Cells in the Treatment of Malignant Hematological Tumors
LymphomaB-Cell5 moreTo evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors