Very difficult. Talquetamab (JNJ-64407564) is a first-in-class bispecific antibody that binds to GPRC5D and CD3 to induce T cell-mediated killing of GPRC5D-expressing MM cells through the recruitment and activation of T cells. 306. Aims Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. However, if the radiation portal covered less than or equal to (<=) of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy; g) gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer [NK] cells) within 3 months, A cumulative dose of corticosteroids equivalent to more than or equal to (>=) 140 milligram (mg) of prednisone within 14 days, Live, attenuated vaccine within 4 weeks prior to first dose of study drug unless approved by sponsor, Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. HealthTree for Multiple Myeloma recently posted summary results of several studies that included talquetamab as part of the clinical treatment program. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).. Deutschland. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Talquetamab Date Designated: 05/03/2021 Orphan Designation: Treatment of Multiple Myeloma Orphan Designation Status: . Myeloma stories, Myeloma clinical trials, Myeloma 101 articles and events with Myeloma IMBRUVICA was first approved by the U.S. Food and Drug Administration (FDA) in November 2013 and today is indicated for adult patients in six disease areas, including five hematologic cancers. Participants with a history of HCV antibody positivity must undergo HCV RNA testing, Known allergies, hypersensitivity, or intolerance to daratumumab, talquetamab, teclistamab, or their excipients. Multiple Myeloma Bispecific Antibody Talquetamab Update, Soporte Para Pacientes de Mieloma Mltiple, First Bispecific Antibody, Teclistamab, Now FDA Approved in Multiple Myeloma, Promising Outcomes of Sequential T-cell Redirection Salvage Therapy After Relapse of Multiple Myeloma, Predicting Neurotoxicities Prior to CAR-T Treatment in Multiple Myeloma, IMS 2022 In Review with Saad Usmani, MD, Memorial Sloan Kettering. 8015 Background: G protein-coupled receptor family C group 5 member D (GPRC5D), which has limited expression in normal human tissue but is highly expressed on malignant plasma cells, is a promising target for multiple myeloma (MM) immunotherapy. Findings from MonumenTAL-1 were presented during the 2022 European Hematology Association (EHA) Annual Congress and also shared at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Number of Participants with anti-drug antibodies to teclistamab will be assessed. Jana Mikulicza-Radeckiego we Wroclawiu, Kaohsiung Medical University Chung-Ho Memorial Hospital, Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit, Istanbul University Istanbul Medical Faculty, On Dokuz Mays University Medical Faculty, Newcastle Upon Tyne, United Kingdom, NE7 7DN, Janssen Research & Development, LLC Clinical Trial. Weienhorn Postal address. Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method. Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method. Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. w. On June 29, 2022 Johnson & Johnson/Janssen announced that the US Food and Drug Administration (FDA) granted talquetamab "Breakthrough therapy designation" for . Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody. ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria. On June 29, 2022 Johnson & Johnson/Janssen announced that the US Food and Drug Administration (FDA) granted talquetamab Breakthrough therapy designation for talquetamab. Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event. I am a firm believer that staying mentally active, physically fit, compliant to our treatment regimen and taking an active interest in our disease are keys to successful treatment outcomes. CR or better response rate (sCR+CR) is defined as the percentage of participants who achieve a CR or better response according to the IMWG criteria. This construct brings the killing T-cell in contact with the cancerous cell. Results can be summarized as follows: Skin-related adverse events and nail disorders. In a presentation through the . Talquetamab is a first-in-class, investigational T-cell redirecting bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, a T-cell receptor. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). A biweekly RP2D was also identified as an SC dose of 800 g/kg talquetamab with step-up doses. Teclistamab is a humanized IgG4PAA bispecific antibody designed to target B cell maturation antigen (BCMA) and the CD3 molecule found on T cells. An AE does not necessarily have a causal relationship with the intervention. Weienhorn Phone. This is a list of most of the side effects I've had since I started talquetamab. Choosing to participate in a study is an important personal decision. All rights reserved. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu, https://www.janssen.com/clinical-trials/transparency. Myeloma stories, Myeloma clinical trials, Myeloma 101 articles and events with Myeloma At the weekly administration, which by the way is subcutaneous . Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. Track your myeloma and find treatment options, Journal your myeloma story in video, audio and writing, Learn from 150+ myeloma experts in video lessons, Find a free personal coach to help navigate your myeloma, Join our new social media app for myeloma patients, Tackle challenges and crush your fitness goals together, Stay up-to-date with thousands of myeloma news articles, Listen to one-on-one interviews with experts on clinical trials, Attend in-person meetings with myeloma experts, Join community groups with other patients and caregivers, Answer survey questions to advance myeloma research, Find answers to commonly asked questions when navigating HealthTree services. Please note that the patients enrolled in these two studies can be labeled as very sick. Information provided by (Responsible Party): The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in combination with pomalidomide and dexamethasone (DPd). (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration Preclinical studies demonstrated that talquetamab works by triggering the death of GPRC5D-expressing cells by binding and activating T-cells. These include indications to treat adults with chronic lymphocytic leukemia (CLL . It also was granted priority medicines (PRIME) designation from the European Medicines Agency (EMA). Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. Phase 1 (NCT03399799) of MonumenTAL-1 was a dose-escalation study, in which participants were given increasingly higher doses of talquetamab to establish a safe dosing schedule. Ks. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. Army Medical University, The First Affiliated Hospital, Zhejiang University College of Medicine, First Affiliated Hospital, SooChow University, Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science, Tongji Hospital, Tongji Medical College of HUST, The First Affiliated Hospital of Xi'an Jiaotong University, Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie, CHRU - Hpital du Haut Lvque - Centre Franois Magendie, Institut Universitaire du cancer de Toulouse-Oncopole, Universittsmedizin der Johannes Gutenberg Universitt, University of Athens - Evaggelismos Hospital (Evangelismos Hospital), 'G. Daratumumab will be administered by SC injection. Quality-of-life data from the same study will be highlighted in a poster presentation (Abstract #1937). A Phase 3 Randomized Study Comparing Talquetamab in Combination With Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of . Over the past week we have seen data from five studies of teclistamab (recently discussed here), long-term follow-up results of their CAR-T product Carvykti and now we can add early results of their novel treatment talquetamab. Individual Participant Data (IPD) Sharing Statement: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. No patients died as a result of an adverse event. The RP2D was originally identified as a weekly SC dose of 405 g/kg talquetamab with step-up doses. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. with My wife, Vicki, and I have two adult children and two grandsons who are the lights of our lives. Time to response is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. Total duration of study will be up to 6 years 6 months. She conducted her postdoctoral research first at the Bristol Medical School, U.K., studying the insulin-PI3K/Akt signaling pathway in diabetic nephropathy, then at the Institute of Molecular Pathology and Immunology of the University of Porto, where her focus was on glycosylation in lupus nephritis and inflammatory bowel disease. Talquetamab, a first-in-class antibody treatment being developed by JanssenResearch & Development, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for hard-to-treat multiple myeloma. MonumenTAL-1 study A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma The purpose of this study is to characterize the safety of Talquetamab and to determine the . Also Roman artifacts and artifacts from the Stone Age have been found. Information provided by (Responsible Party): The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1) and to characterize the safety of the RP2R(s) for the study treatment (Part 2). The company and its researchers conclude that, Results from the study show heavily pretreated patients with multiple myeloma treated with the combination, including talquetamab at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks (Q2W), achieved high rates of responses, including for patients refractory to anti-CD38 treatment.. Talquetamab (JNJ-64407564) is a first-in-class, bispecific IgG4 antibody that binds to both GPRC5D and CD3 receptors, mediating T-cell-activated . Dexamethasone will be administered orally or intravenously. My wife, Vicki, and I have two adult children and two grandsons who are the lights of our lives. The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher. Individual Participant Data (IPD) Sharing Statement: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. Updated results from the Phase 1 MonumenTAL-1 study of talquetamab and the first results from the Phase 2 portion of the MonumenTAL-1 study will be featured in the ASH press program and as an oral presentation (Abstract #157). Two dosing levels were identified: 405 and 800 micrograms/kg (g/kg body weight). Overall response rates were 70% (405 mcg/kg group) and 64% (800 mcg/kg group), with 57% and 52%, respectively, achieving a very good partial response or better rate. Cytokine release syndrome (CRS), a potentially life-threatening complication characterized by fever and multiple organ dysfunction, also was frequently observed. Talquetamab (JNJ-64407564) is a bispecific antibody binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells. Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method. CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria. Clinical Trial Information . Total duration of study is up to 1 year and 6 months. The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Teclistamab will be administered by SC injection. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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