"This Breakthrough Therapy Designation marks an important step in the continued development of talquetamab, a first-in-class bispecific antibody T-cell engager using GPRC5D, a novel target for the treatment of patients with relapsed or refractory multiple myeloma," said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and . For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses. Daratumumab will be administered subcutaneously. Detailed Description: Participants will receive Talquetamab SC. 653.Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials. NCT05050097 - A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma. 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). Talquetamab. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose of study drug, Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. Teclistamab, daratumumab, talquetamab Ib Recruiting Global NCT04586426, EudraCT2019-004124-38, RedirecTT-1 Janssen Research & Development . Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. Number of participants with anti-drug antibodies to rHuPH20 will be reported. 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 . In this video: . Antibodies to Talquetamab will be assessed to evaluate potential immunogenicity. The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. Brief Summary: The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations. Clinical Trials Survey & Studies HealthTree Publications HealthTree . Individual Participant Data (IPD) Sharing Statement: https://www.janssen.com/clinical-trials/transparency. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Participants will receive talquetamab subcutaneously (SC). English; Regulations. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The dose levels will be selected to identify safe and tolerable putative RP2D(s). For general information, Learn About Clinical Studies. Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. PFS2 is defined as time from randomization to progression on the first subsequent line of therapy or death due to any cause, whichever comes first. EQ-5D-5L is a generic measure of health status. One of the benefits of this drug is that it is administered subcutaneously rather than intravenously, which can be less distressing for patients. The binding of both activates the immune system to attach the myeloma cells. See also Status Clinical Trial Phase; Not yet recruiting NCT05519085 - A Study to Evaluate CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) : Phase 3: Completed NCT03837509 - INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or . ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria. 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: . In the trial, 184 patients received talquetamab, 102. Please remove one or more studies before adding more. The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. Number of participants with DLT will be reported. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The study will be conducted in 2 parts: dose escalation and dose expansion. I recently sat in on the update of the TRIMM-2 study presented by Ajai Chari, MD, Mount Sinai School of Medicine. The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS). Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Overall Response Rate (ORR) [TimeFrame:Up to 1 year 3 months], Progression-free Survival (PFS) [TimeFrame:Up to 1 year 3 months], Very Good Partial Response (VGPR) or Better Response Rate [TimeFrame:Up to 4 years], Complete Response (CR) or Better Response Rate [TimeFrame:Up to 4 years], Overall Survival (OS) [TimeFrame:Up to 4 years], Time to Progression on the First Subsequent Line of Therapy or Death, Whichever Comes First (PFS2) [TimeFrame:Up to 4 years], Number of Participants with Adverse Events (AEs) [TimeFrame:Up to 4 years], Number of Participants with AEs by Severity [TimeFrame:Up to 4 years], Number of Participants with Abnormalities in Clinical Laboratory Assessments [TimeFrame:Up to 4 years], Serum Concentration of Talquetamab [TimeFrame:Up to 4 years], Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab [TimeFrame:Up to 4 years], Titers of ADAs to Talquetamab [TimeFrame:Up to 4 years], Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) [TimeFrame:Baseline up to 4 years], Change from Baseline in EuroQol 5-Dimension Questionnaire 5-Level (EQ-5D-5L) [TimeFrame:Baseline up to 4 years], Change from Baseline in EuroQol 5-Dimension Questionnaire 5-Level (FACT-G) [TimeFrame:Baseline up to 4 years], Time to Sustained Worsening in EORTC-QLQ-C30 [TimeFrame:Up to 4 years], Time to Sustained Worsening in EQ-5D-5L [TimeFrame:Up to 4 years], Time to Sustained Worsening in FACT-G [TimeFrame:Up to 4 years], Documented multiple myeloma as defined by the criteria: a) multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria b) measurable disease at screening, as assessed by central laboratory, defined by any of the following i) serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) ii) urine M-protein level >=200 milligram (mg)/24 hours iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum free light chain (sFLC) >=10 milligram per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain (FLC) ratio, Received at least 4 prior antimyeloma therapies including an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb) (alone or in combination) and is refractory per IMWG criteria to at least one proteasome inhibitor (PI), and one immunomodulatory drug (IMiD), Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen, Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening, A female participant of childbearing potential must have a negative serum pregnancy test at screening, and must agree to further serum or urine pregnancy tests during the study and within 6 months after receiving the last dose of study treatment, Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients, Stroke or seizure within 6 months prior to signing informed consent form (ICF), Prior or concurrent exposure to belantamab mafodotin, Current corneal epithelial disease except mild punctate keratopathy, Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050097. Blood. 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. Carfilzomib will be administered as an IV infusion. FACT-G is a 27-item questionnaire designed to measure 4 domains of HRQoL in cancer patients: physical, social, emotional, and functional well-being. You have reached the maximum number of saved studies (100). Number of participants with anti-teclistamab antibodies will be reported. For appointments, contact your preferred doctor or location directly. Talquetamab is an off-the-shelf bispecific antibody that targets GPRC5D on myeloma cells and CD3 on T cells. Ajai Chari, MD, discusses the safety and efficacy of talquetamab plus daratumumab in heavily pretreated patients with multiple myeloma, initial data from phase 1b TRIMM-2 trial, and the potential . Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05503550. Other Name: JNJ-64407564 Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Safety evaluations will include a review of adverse events, physical examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, and vital signs. Study Summary. For the Mario Lemieux Center for Blood Cancers, call 412-864-6600. 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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Clinical Trials Registry. Overall rationale of study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. A high scale score represents a higher response level. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Uniwersytecki Szpital Kliniczny im. 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, you can look at the national clinical trial registry at https://clinicaltrials.gov The Phase 2 trial is number: NCT04634552. He reviewed the latest results of this study, which explores the synergistic effect of combining talquetamab (Tal) with . MCT Tags; NDMM Trials; RRMM Trials; MGUS/SMM Trials; Phase 3 Trials; Phase 2 Trials; Phase 1/2 Trials; Phase 1 . Part 2: Participants with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies; Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio; If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%, Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine, Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. The treatment is free. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Monique Minnema, MD, discusses the rationale of the MonumenTAL-1 trial examining . 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 . Talquetamab is currently being evaluated in a Phase 1/2 clinical study for the treatment of relapsed or refractory multiple myeloma and is also being explored in combination studies. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. ClinicalTrials.gov Identifier: NCT03399799, Interventional OS is defined as the time from randomization to date of death due to any cause. hypercalcemia, and renal failure. View duration, location, compensation, and staffing details. Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody. For general information, Learn About Clinical Studies. MYELOMA CLINICAL TRIALS. 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). Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. Ryan Scott. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. 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. The agent targets the novel biomarker GPRC5D on multiple myeloma cells and CD3 on T-cells. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399799. 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. Other clinical pearls, according to Aronson, include certain dietary modifications and early treatment of oral candida. Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Talquetamab administered to adult participants with relapsed or refractory multiple myeloma. Jana Mikulicza-Radeckiego we Wroclawiu, Champalimaud Foundation Champalimaud Centre, Janssen Research & Development, LLC Clinical Trial. Information provided by (Responsible Party): The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor. van de Donk, MD, a hematologist at the VU University Medical Center in Amsterdam, The Netherlands, said in a virtual presentation during the meeting. ClinicalTrials.gov Identifier: NCT05338775, Interventional Talquetamab will be administered as subcutaneous injection. Talquetamab Monotherapy Shows Early Promise in Relapsed/Refractory Multiple Myeloma. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data. 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. . 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. Lenalidomide will be self-administered orally. Teclistamab will be administered as a SC injection. You have reached the maximum number of saved studies (100). In preclinical studies, talquetamab induced activation and degranulation of T . Clinical Trials on Talquetamab. Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. US Clinical Trials Registry; EU Clinical Trials Registry . 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 . June 29, 2022 (RARITAN, N.J.) - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome . If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required, Known to be seropositive for human immunodeficiency virus, History of stroke or seizure within 6 months prior to the first dose of study treatment. ClinicalTrials.gov Identifier: NCT05050097, Interventional Serum samples will be analyzed to determine concentrations of Teclistamab using validated, specific, and sensitive immunoassay methods. 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). Talk with your doctor and family members or friends about deciding to join a study. CR or better response is defined as percentage of participants with best overall response of CR or better according to IMWG criteria. 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. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For doctor- or location- specific contact information, search UPMC Hillman Cancer Center doctors and locations. CD3 is involved in activating T-cells and GPRC5D is highly expressed on multiple myeloma cells. sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. Ks. (Clinical Trial), A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma, Experimental: Treatment Regimen A: Talquetamab + Carfilzomib, Experimental: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib, Experimental: Treatment Regimen C: Talquetamab + Lenalidomide, Experimental: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide, Experimental: Treatment Regimen E: Talquetamab + Pomalidomide, 18 Years and older (Adult, Older Adult), Birmingham, Alabama, United States, 35294, San Francisco, California, United States, 94143, Indianapolis, Indiana, United States, 46202, Saint Louis, Missouri, United States, 63110-1032, Hackensack, New Jersey, United States, 07601, Charlotte, North Carolina, United States, 28204, Pittsburgh, Pennsylvania, United States, 15232, Nashville, Tennessee, United States, 37203, Seattle, Washington, United States, 98109, Milwaukee, Wisconsin, United States, 53226, Institut Universitaire du cancer de Toulouse-Oncopole, Janssen Research & Development, LLC Clinical Trial. Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory . The end of study (study completion) is defined as the last study assessment for the last participant in the study. A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma. 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. 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. 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) . The PD-1 inhibitor will be administered as an intravenous injection. 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. Talquetamab is a 'first in class' bispecific antibody that targets the GPRC5D, a new target expressed on myeloma cells, and CD3, a protein expressed on T-cells. CD3, a protein expressed on the surface of T-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. Apply to this Phase 3 clinical trial treating Relapsed Or Refractory Multiple Myeloma, Multiple Myeloma, Neoplasms, Plasma Cell. 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. Interestingly, it's also expressed in epidermal tissues. (Clinical Trial), A Phase 3 Study Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma Who Have Received at Least 4 Prior Therapies Including an Immunomodulatory Drug, a Proteasome Inhibitor, and an Anti-CD38 Antibody, Active Comparator: Arm B: Belantamab Mafodotin, 18 Years and older (Adult, Older Adult), Fayetteville, Arkansas, United States, 72703, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205, San Francisco, California, United States, 94143, Norwalk, Connecticut, United States, 06850, Washington, District of Columbia, United States, 20007, Jacksonville, Florida, United States, 32224, New Orleans, Louisiana, United States, 70112, New Orleans, Louisiana, United States, 70121, Walter Reed National Military Medical Center, Boston, Massachusetts, United States, 02215, Detroit, Michigan, United States, 48201-2013, Rochester, Minnesota, United States, 55905, Saint Luke's Hospital - Saint Luke's Cancer Specialists, Chesterfield, Missouri, United States, 63017, Charlotte, North Carolina, United States, 28204, Winston-Salem, North Carolina, United States, 27103, Philadelphia, Pennsylvania, United States, 19104, University of Texas Southwestern Medical Center, Salt Lake City, Utah, United States, 84112, Virginia Commonwealth University - Massey Cancer Center, University of Wisconsin Carbone Cancer Center, Milwaukee, Wisconsin, United States, 53226-3522, CIUSSS de l'Est-de-l'le-de-Montral Installation Hpital Maisonneuve-Rosemont, Universitaetsklinikum Schleswig-Holstein Campus Kiel. Get access to cutting edge treatment via Talquetamab, Belantamab Mafodotin. Number of participants with anti-talquetamab antibodies will be reported. 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 Multiple myeloma is the most common disease being investigated in talquetamab clinical trials [ 2 ]. You have reached the maximum number of saved studies (100). 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. Primary objectives of part 1 of the trial was identification of the RP2D whereas safety and tolerability were the objectives of part 2.
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