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Randomized Phase II Study in Elderly Patients With Newly Diagnosed Multiple.
To compare the efficacy and safety of bortezomib, lenalidomide and dexamethasone in elderly frail patients with newly diagnosed multiple myeloma 1. Primary Study Objective - Progression-Free Survival : The time from randomization into the date of first observation of documented disease progression or any-kinds of death. 2. Secondary Study Objectives 1) Complete Response (CR) - Response will be determined by the International Myeloma Working Group Response Criteria - CR is defined as negative immunofixation on the serum and urine and disappearance ...
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REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Participants With Relapsed/Refractory Multiple Myeloma
The primary objective of the study is to assess the safety and tolerability, and identify the recommended dose of REGN5458 for the expansion portion in combination with each one of the following cancer treatments: - Daratumumab plus dexamethasone (Dd: Cohort 1) - Carfilzomib plus dexamethasone (Kd: Cohort 2) - Lenalidomide plus dexamethasone (Rd: Cohort 3) - Bortezomib plus dexamethasone Vd: (Cohort 4) The secondary objectives of the study for each cohort are: - To assess the preliminary anti-tumor activity by International Myeloma Working Group (IMWG) criteria - To measure...
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Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.
The aim of our study is to confirm the relevance of PET using [68Ga]Ga-PentixaFor ligand, in comparison with FDG, for initial staging and detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga-PentixaFor/FDG discordances explored.
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Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics
Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Despite impressive results, too many patients are relapsing. The reasons for the relapse, after the injection of CAR T cells, need to be explored. In this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with CAR T Cells, especially the characteristics of the tumor and its ...
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Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.
The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021. The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and the safety of single agent belantamab mafodotin in patients with RRMM. Subjects may receive treatment until progression. Myeloma disease status will be evaluated ...
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Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
This phase II trial studies the effect of selinexor when combined with carfilzomib, daratumumab, and dexamethasone in treating patients with high-risk multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory) and who have received 1-3 prior lines of therapy. Selinexor may stop the growth of cancer cells by blocking a protein called CRM1 that is needed for cell growth. Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found within cells that has the important role of identifying and marking damaged proteins that are needed to be destroyed by the cell for...
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Selinexor in Combination With Thalidomide and Dexamethasone in RRMM
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This is a single-arm that includes escalation phase and expansion phase ,Selinexor in Combination withThalidomide and Dexamethasone to Treat Relapsed/Refractory Multiple Myeloma Patients.To evaluate efficacy and safety of Selinexor in combination with Thalidomide and Dexamethasone in RRMM patients received at least one prior lines of therapy
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Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of...
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SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in patients with relapsed or refractory multiple myeloma and other hematological malignancies
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Study of 3D189 in Patients With Hematologic Malignancies
To assess the safety, immunogenicity and preliminary efficacy of 3D189 in patients with hematological malignancies.
