Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. We present a phase I/II first-in-human trial evaluating the safety and efficacy of 50 mg and 200 mg doses of linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody in relapsed/refractory multiple myeloma (RRMM). Phase II eligible patients had RRMM that either progressed on/after ≥three lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody or was triple-class (PI/IMiD/anti-CD38) refractory. Phase II treatment was once a week through week 14 and then once every 2 weeks. Phase II 200 mg patients who achieved a ≥very good partial response by week 24 received linvoseltamab once every 4 weeks. The primary end point in phase II was overall response rate (ORR
Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will: 1. Get rid of any residual multiple myeloma cells in participants' bodies which is known that participants' disease responds to treatment. The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.
Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy This study is researching an experimental drug called linvoseltamab when combined with another drug called dupilumab. The study is focused on patients who have IgE-mediated food allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergen bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab.The study is looking at several other research
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) This study is researching an experimental drug called linvoseltamab ("study drug").This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.The study consists of 2 phases (Phase 1 and Phase 2):In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL
Compassionate Use of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Who Have Been Previously Treated With Linvoseltamab and Background Dupilumab Provide compassionate use of dupilumab in adults with severe IgE-mediated food allergy who have been previously treated with linvoseltamab and background dupilumab Compassionate Use requests are only being considered
A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined ). This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab
A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma This study is researching an investigational drug called linvoseltamab ("study drug") in participants at high risk of developing multiple myeloma (MM), a group commonly labeled as high-risk smoldering multiple myeloma (HR-SMM ).The aim of the study is to understand the safety and tolerability (how your body reacts to linvoseltamab) as well as the effectiveness (how well linvoseltamab eliminates plasma cells and prevents the development of MM) of the study drug. There are 2 parts to the study.In Part 1, linvoseltamab will be given to a small number of participants to study the early side effects (safety) of the study drug
A Proof-of-concept Study to Learn Whether Linvoseltamab Can Prevent Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma The primary purpose of the study is to investigate whether early treatment with the study drug can prevent the development of multiple myeloma. This requires understanding the safety and tolerability of the study drug (how your body reacts to linvoseltamab) as well as the effectiveness of the study drug (how well linvoseltamab eliminates plasma cells and prevents the development of multiple myeloma). All participants will start treatment with gradually increasing doses of linvoseltamab (step-up doses) before they start receiving the assigned full dose. The study is split into 2 parts.In Part
A Study to Learn How Linvoseltamab (REGN5458) Will Work Compared to the Elotuzumab, Pomalidimide and Dexamethasone (EPd) Combination, in Participants With Relapsed/Refractory Multiple Myeloma The primary objective of this study is to compare progression-free survival (PFS) per the Independent Review Committee (IRC) between participants treated with linvoseltamab monotherapy and EPd.The key secondary objectives are:To compare the anti-tumor activity per IRC between linvoseltamab monotherapy and EPd as measured byobjective response≥very good partial response (VGPR)≥ complete response (CR)To compare the incidence of minimal residual disease (MRD) negative status (10^-5) in the bone marrow between linvoseltamab monotherapy and EPdTo compare overall survival (OS) between linvoseltamab
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment. The primary objectives of the study are:For Phase 1To find out if linvoseltamab is safe and well toleratedTo find out what the most appropriate dosing schedule would be for future clinical trialsFor Phase 2•To find out if it works to treat multiple myelomaThe secondary objectives of the study are:For Phase 1 and 2To find out how linvoseltamab moves throughout the body over time (pharmacokinetics)To find out how much B-cell maturation antigen (BCMA) participants have in their bloodTo find out if the participants' immune systems respond to linvoseltamab. undefined
Bispecific antibodies targeting BCMA, GPRC5D, and FcRH5 for multiple myeloma therapy: latest updates from ASCO 2023 Annual Meeting. Several bispecific antibodies (bsAbs) targeting BCMA, GPRC5D, and FcRH5 are in clinical trials for heavily pretreated multiple myeloma (MM) patients. Teclistamab was approved for relapsed/refractory MM therapy in 2022, while elranatamab, linvoseltamab, F182112
IMMUNOPLANT for Newly Diagnosed Multiple Myeloma The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad ) that Linvoseltamab has on participants and the condition. undefined