Preclinical studies demonstrated that talquetamab works by triggering the death of GPRC5D-expressing cells by binding and activating T-cells. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. 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. The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). A high scale score represents a higher response level. Participants will receive belantamab intravenously (IV). . Information provided by (Responsible Party): The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 [Dose Escalation]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]). Talquetamab was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses. 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. You can use your HealthTree data to see if you qualify to join a talquetamab trial. H. Swiecickiego Uniwersytetu Medycznego im. Talk with your doctor and family members or friends about deciding to join a study. NCT05050097 - A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma. Please remove one or more studies before adding more. Please remove one or more studies before adding more. Maybe you have heard about clinical trials, and like me have been a bit confused, curious or even dubious. Talquetamab (JNJ-64407564) is a first-in . Participants will receive Talquetamab SC. US Clinical Trials Registry; EU Clinical Trials Registry . It also binds CD3, a protein on the surface of immune T-cells. CD3, a protein expressed on the surface of T-cells. In its Physical Well-Being subscale, the FACT-G includes a question concerning side effect bother (item GP5: "I am bothered by side effects of treatment"), rated on a 5-point Likert scale from "not at all" to "very much." View Clinical Trials for talquetamab. products Our groundbreaking accomplishments 6 Approved therapies incorporating Genmab innovation 4 The treatment is free. 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. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The item and scale scores are transformed to a 0 to 100 scale. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Monique Minnema, MD, discusses the rationale of the MonumenTAL-1 trial examining . DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria. Why Should I Register and Submit Results? Participants will receive IV infusion of Talquetamab at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Number of participants with ADAs to talquetamab will be reported. Initial clinical results from the phase 1b multicohort TRIMM-2 study identified the recommended phase 2 doses (RP2Ds) and support the combination of tal plus dara for the treatment of RRMM, with manageable safety, no overlapping toxicities, and promising . VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria. This single item will be included as an overall summary measure of the burden of treatment toxicities compared with each other. Response to treatment will be evaluated by the investigator based on IMWG criteria. Ks. Detailed Description: If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required. Antibodies to Talquetamab will be assessed to evaluate potential immunogenicity. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. Ryan Scott. 5,6 results from preclinical studies in mouse The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. ORR is defined as percentage of participants with confirmed best overall response of partial response (PR) or better according to international myeloma working group (IMWG) criteria. English; Regulations. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399799. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. But there are six trials recruiting! Information provided by (Responsible Party): 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. For doctor- or location- specific contact information, search UPMC Hillman Cancer Center doctors and locations. talquetamab is a first-in-class, investigational t-cell redirecting bispecific antibody targeting both gprc5d, a novel multiple myeloma target that does not shed over time, and cd3, the t-cell receptor. Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive electrochemiluminescent immunoassay (ECLIA) method. Other clinical pearls, according to Aronson, include certain dietary modifications and early treatment of oral candida. Clinical Trials on Talquetamab. Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. ICH GCP. The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose (s) (RP2Ds) (Part 3). The study will consist of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up. Pomalidomide will be self-administered orally. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Talquetamab administered to adult participants with relapsed or refractory multiple myeloma.The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance . K. Marcinkowskiego w Poznaniu, Narodowy Instytut Onkologii im. Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods. The dose levels will be selected to identify safe and tolerable putative RP2D(s). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Talquetamab is a humanized IgG4PAA bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). Choosing to participate in a study is an important personal decision. Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma: A.3.1: Title of the trial for lay people, in easily . Multiple myeloma is an incurable, malignant, plasma cell disorder that accounts for approximately 18 percent (%) of hematological malignancies, making it the second most common hematologic malignancy. The study will consists of a screening phase, treatment phase (until confirmed progressive disease, start of subsequent antimyeloma therapy, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and post-treatment follow-up phase (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Talquetamab will be administered subcutaneously (SC). Multiple Myeloma Patient Education. Talquetamab (JNJ-64407564) is a first-in-class bispecific IgG4 antibody that redirects T cells to kill MM cells by binding to both GPRC5D and CD3 receptors. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. Why Should I Register and Submit Results? Talquetamab has been investigated in 3 clinical trials, of which 3 are open and 0 are closed. ClinicalTrials.gov Identifier: NCT05503550, Pre-Approval Access Single Patient Request Treatment for Talquetamab for Treating Physician Use in Relapsed or Refractory Multiple Myeloma, 18 Years and older (Adult, Older Adult), Janssen Research & Development, LLC Clinical Trial. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05461209. The development of the antibody followed Janssen Biotech, Inc.'s licensing agreement with Genmab for use of its DuoBody technology platform. ClinicalTrials.gov Identifier: NCT04634552 Official Title: A Phase 1/2, 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 First Posted : November 18, 2020 Click here to see details on ClinicalTrials.gov Drug: Talquetamab In a phase 1 clinical trial (MagnetisMM-1 trial, NCT03269136), 58 patients with RRMM received weekly subcutaneous . A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma (TRIMM-3) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. You have reached the maximum number of saved studies (100). The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. 2020 Apr 9;135(15):1232-1243. doi: 10.1182/blood.2019003342. An updated analysis of the phase 1 MonumentTAL-1 trial (NCT03399799) showed the recommended phase II dose (RP2D) of talquetamab was durable and continuous compared with a subcutaneous dose, with an overall response rate of 70%, especially in triple-refractory (65.2%) and penta-refractory (83.3%) patients with relapsed/refractory (R/R) multiple myeloma, in a presentation during the 2021 virtual . Why Should I Register and Submit Results? . MCT Tags; NDMM Trials; RRMM Trials; MGUS/SMM Trials; Phase 3 Trials; Phase 2 Trials; Phase 1/2 Trials; Phase 1 . Genetic and Rare Diseases Information Center, A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma. 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. This drug entry is a stub and has not been fully annotated. PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Serum concentrations will be calculated for Talquetamab. Carfilzomib will be administered as an IV infusion. Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. Number of participants with anti-drug antibodies to talquetamab will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Each entry includes links to find associated clinical trials. CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. Please remove one or more studies before adding more. Talk with your doctor and family members or friends about deciding to join a study. For appointments, contact your preferred doctor or location directly. MYELOMA CLINICAL TRIALS. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses. 1 cd3 is involved in activating t-cells, and gprc5d is highly expressed on multiple myeloma cells. Number of participants with anti-PD-1 inhibitor antibodies will be reported. Serum samples will be analyzed to determine concentrations of PD-1 inhibitor using validated, specific, and sensitive immunoassay methods. Updated Phase 1 Results from MonumenTAL-1: First-in-Human Study of Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D x CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma . An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Of the trials investigating talquetamab, 2 are phase 1 (2 open) and 1 is phase 2 (1 open). Janssen Research & Development, LLC Clinical Trial: Study Director: Janssen Research & Development, LLC: Overall Contact: Last Name: Study Contact Phone: 844-434-4210 Email: [email protected] Location: . ClinicalTrials.gov Identifier: NCT05338775, Interventional To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Pillarisetti K, Edavettal S, Mendona M, Li Y, Tornetta M, Babich A, Majewski N, Husovsky M, Reeves D, Walsh E, Chin D, Luistro L, Joseph J, Chu G, Packman K, Shetty S, Elsayed Y, Attar R, Gaudet F. A T-cell-redirecting bispecific G-protein-coupled receptor class 5 member D x CD3 antibody to treat multiple myeloma. For general information or questions, call 412-647-2811. A multicentre, randomized, open-label, phase III trial (NCT05243797; MajesTEC-4) will be investigating the efficacy and safety of teclistamab plus lenalidomide, compared with . B. Markiewicza, Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Szpital Kliniczny im. In this video: . Latest data from MonumenTAL-1 trial of talquetamab in heavily pretreated relapsed/refractory multiple myeloma, from ASH 2021 and reported by Clinical Care Options (CCO) This study will investigate the possible improvement of ORR or PFS with talquetamab compared with belantamab mafodotin in participants with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 mAb (alone or in combination), and whose disease is refractory to at least one proteasome inhibitor (PI) and one immunomodulatory drug (IMiD). Talk with your doctor and family members or friends about deciding to join a study. US Clinical Trials Registry Kliniske forsg Nct side Virkning af tidlig mobilisering p opholdets lngde, genopretning og tilbagetagelseshastighed for patienter efter CABG eller AVR / MVR-kirurgi DB16678. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease, Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of Talquetamab, Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy, Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication), An allogenic stem cell transplant within 6 months before first dose of study drug.
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