For general information, Learn About Clinical Studies. 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. I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find successful treatment at the division of Cellular Therapy at the Duke University Cancer Institute. However, alternative dosing schedules that require less frequent administration continue to be investigated. Choosing to participate in a study is an important personal decision. 3 CD3 is involved in . Both doses had similar profiles in terms of pharmacokinetics, the movement of a treatment throughout the body, and pharmacodynamics, the interactions between the body and a compound. Papanikolaou' Hospital of Thessaloniki, Anticancer Hospital of Thessaloniki 'Theageneio', A.O. The designation was awarded based on the positive safety and efficacy findings of a Phase 1/2 clinical trial involving adults with relapsed or refractory multiple myeloma (RRMM) who previously received at least four lines of therapy. Pensacola, FL 32502 Why Should I Register and Submit Results? 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. She next made the switch to science publishing, handling papers in biochemistry, molecular biology, and immunology. On the June 29, 2022, talquetamab was granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for use in patients with relapsed/refractory multiple myeloma. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Suite 700 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. In a presentation through the . My wife, Vicki, and I have two adult children and two grandsons who are the lights of our lives. This was for talquetamab, which again targets this specific anchor. Despite the therapies available for patients with relapsed or refractory multiple myeloma, new targets and treatments are needed because of the heterogeneity of the disease, which can impact a patients response to treatment, Zhuang said. 5,6 results from preclinical studies in mouse Talquetamab (JNJ-64407564) is a first-in-class, bispecific IgG4 antibody that binds to both GPRC5D and CD3 receptors, mediating T-cell-activated . Talquetamab was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. Teclistamab will be administered by SC injection. All rights reserved. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria. Pronunciation of talquetamab with 3 audio pronunciations. Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. JNJ has presented Phase I data with both mono treatment with talquetamab and combination treatment with talquetamab + Darzalex Faspro. Nearly all of the patients had been triple class exposed prior to relapse, about 75 percent. Talquetamab last year also received orphan drug status from the FDA. Talquetamab is a GPRC5D x CD3 bispecific antibody designed to bind to CD3 and GPRC5D to redirect T cells, thereby killing myeloma cells. The 2-part, ongoing, first-in-human, phase 1 MonumenTAL-1 trial is evaluating talquetamab at the RP2D of 405 g/kg given weekly and via subcutaneous administration in patients with relapsed/refractory multiple myeloma. The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). About Talquetamab Talquetamab is a first-in-class, off-the-shelf, . Listing a study does not mean it has been evaluated by the U.S. Federal Government. An AE does not necessarily have a causal relationship with the intervention. This is so bad that at times my teeth stick to the inside of my mouth. (a) For cohorts without daratumumab, prior lines of therapy must include a proteasome inhibitor (PI) (example, bortezomib, carfilzomib, ixazomib), an immunomodulatory drug (IMiD) (example, thalidomide, lenalidomide, pomalidomide), and an anti-CD38 therapy (example, daratumumab, isatuximab) in any order. The agent targetsthe novel biomarker GPRC5D on multiple myeloma cells and CD3 on T-cells. Other common adverse events included infections (47% and 34%), skin- and nail-related disorders (83% and 75%), and dysgeusia, or an altered sense of taste (63% and 57%). That being said, we will still be several years away before we will see this addition to myeloma treatment in clinical practice, though every added treatment option provides added hope for us. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Weienhorn Civic centre fax number. SparkCures ID. For Government; For Press; Combination Products; 1 Systemic administration-related reactions occurred in 8% of patients with the first injection . Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method. 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. Vanda is a biochemist with a PhD in biomedicine from the University of Porto, Portugal. Weienhorn Phone. Number of participants with presence ADAs to talquetamab will be reported. Website: bionews.com Participants safety and study conduct will be monitored throughout the study. Difficult. This is a list of most of the side effects I've had since I started talquetamab. Meanwhile, patients in the 800 mcg/kg group had received five prior therapies. The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank. Teclistamab is a humanized IgG4PAA bispecific antibody designed to target B cell maturation antigen (BCMA) and the CD3 molecule found on T cells. 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. Talquetamab is a first-in-class investigational bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, the T-cell receptor. The FDA awards breakthrough therapy designation to accelerate the development of investigational treatments for serious or life-threatening conditions. 07309 840. International: +49 7309 840. It is based on preliminary clinical evidence showing a therapys improvement on at least one clinically significant goal compared with existing treatments. Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication. Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life Please remember that a Phase I study evaluates safety, preliminary efficacy as well as recommended Phase II dosing (RP2D) for follow-on human studies to support the registration dossiers with regulatory agencies in the future. This construct brings the killing T-cell in contact with the cancerous cell. Phone: 1-800-936-1363. Talquetamab (JNJ-64407564) is a bispecific antibody binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells. with 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. 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. You have reached the maximum number of saved studies (100). Patients were stepped-up gradually to the target dose in order tomitigate severe cytokine release syndrome (CRS) and required pre-medications were administered during this step-up period. Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event. Talk with your doctor and family members or friends about deciding to join a study. 306. Daratumumab will be administered by SC injection. (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. 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.. It does not provide medical advice, diagnosis or treatment. Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Myeloma stories, Myeloma clinical trials, Myeloma 101 articles and events with Myeloma ClinicalTrials.gov Identifier: NCT04586426, Interventional 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. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. A biweekly RP2D was also identified as an SC dose of 800 g/kg talquetamab with step-up doses. 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. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs. . 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. Darzalex Faspro was dosed at the approved dosing level. DOR will be calculated among responders (with PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria. Dexamethasone will be administered orally or intravenously. . Weienhorn was first mentioned in 1160 as villa Wizzenhorn. 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. Subscribe to the weekly "HealthTree Community for Myeloma Newsletter" for Myeloma news, life To explore the feasibility of talquetamab in the RRMM setting, a first-in-human phase I study of talquetamab in patients with RRMM was conceived (NCT03399799).The results were presented by Ajai Chari during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition 1 and are summarized below.. Study design 1. Ks. 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. MonumenTAL-1 is a phase 1 trial evaluating the safety and preliminary efficacy of talquetamab in patients with relapsed/refractory MM (RRMM) (NCT03399799). HealthTree Foundation / Myeloma Crowd is a qualified 501(c)(3) tax-exempt organization. Teclistamab was recently granted conditional approval in the EU for the treatment of adult patients with relapsed and refractory multiple myeloma who have received three or . Efficient strategies of mitigating oral and dermatologic treatment-emergent adversarial occasions (TEAEs) generally reported with talquetamab might embrace preventative ways initiated in the beginning of remedy. When it expired in 1342, Weienhorn came into possession of the dukes of Bavaria, which had pawned . Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method. Pomalidomide will be administered orally. Very difficult. The RP2R(s) will describe the combination doses and schedules of (tal+tec+dara) the treatment combinations to be pursued in Phase 2. Talquetamab, a first-in-class antibody treatment being developed by Janssen Research & Development, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for hard-to-treat multiple myeloma. VGPR or better response rate (sCR+CR+VGPR) is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria. Number of participants with presence of ADAs to daratumumab will be reported. 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 inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Talquetamab is one of several new drugs in the hopper that are giving us triple+ refractory myeloma patients a heart full of hope. 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. Talquetamab Date Designated: 05/03/2021 Orphan Designation: Treatment of Multiple Myeloma Orphan Designation Status: . Results can be summarized as follows: Skin-related adverse events and nail disorders. 1 cd3 is involved in activating t-cells, and gprc5d is highly expressed on multiple myeloma cells. In humans, talquetamab was tested in the Phase 1/2 MonumenTAL-1 study, which recruited heavily pretreated adults with RRMM. According to study findings, two recommended doses, both under-the-skin injections, were identified: 405 mcg (microgram)/kg weekly and 800 mcg/kg once every two weeks. 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. 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). The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. Deutschland. Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody. Total duration of study will be up to 6 years 6 months. FDA Grants Breakthrough Therapy Designation to Talquetamab for Multiple Myeloma, 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, summary results of several studies that included talquetamab. The agent targets the novel biomarker GPRC5D on multiple myeloma cells and CD3 on T-cells. Citt della Salute e della Scienza, Dokkyo Medical University Saitama Medical Center, National Hospital Organization Matsumoto Medical Center, Chonnam National University Hwasun Hospital, Severance Hospital, Yonsei University Health System, The Catholic University of Korea, Seoul St. Mary's Hospital, Albert Schweitzer ziekenhuis-lokatie Dordwijk, Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Daratumumab will be administered subcutaneously. 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. The RP2D was originally identified as a weekly SC dose of 405 g/kg talquetamab with step-up doses. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05455320. Data showed that talquetamab helped kill cancer cells by targeting two specific proteins GPRC5D and CD3 at the same time. Talquetamab will be administered subcutaneously. The range for dosing was biweekly or weekly treatment at a dosage of 1.5 to 180 g/kg with IV administration and 5 to 800 g/kg with . 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. Moderate. Easy. Teclistamab (TECVAYLI), a bispecific antibody that targets CD3 and B cell maturation antigen (BCMA), is being developed by Janssen Research and Development for the treatment of relapsed or refractory multiple myeloma. Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of . Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. The RP2D was originally identified as a weekly SC dose of 405 g/kg talquetamab with step-up doses. CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria. Participants will receive talquetamab and daratumumab as injection SC injection. Number of Participants with anti-drug antibodies to teclistamab will be assessed. July 11, 2022. The 2-part, ongoing, first-in-human phase 1 MonumenTAL-1 trial is evaluating talquetamab at the RP2D of 405 g/kg given weekly and via subcutaneous administration in patients with relapsed/refractory multiple . If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required, Plasma cell leukemia at the time of screening, Waldenstrm's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis. Myeloma stories, Myeloma clinical trials, Myeloma 101 articles and events with Myeloma 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. 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. The median time to the first confirmed response was about one month for both groups. 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. 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. Dysgeusia In preclinical models, talquetamab induced cell killing of primary MM cells and inhibited tumor formation and growth in MM mouse models I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find successful treatment at the division of Cellular Therapy at the Duke University Cancer Institute. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank. 2 /5. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs. Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the RP2R(s) of the study treatment identified in Part 1. It also binds CD3, a protein on the surface of immune T-cells. Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed, Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen, Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment, Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients, Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody), A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug, Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. Generic Name. 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. Median follow-up was almost a year for those in the first group and about four months for those in the second. 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. U.S. Food and Drug Administration. Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria. Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. No patients died as a result of an adverse event. Most of the reported adverse events (side effects) were mild or moderate in severity. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. Rate the pronunciation difficulty of talquetamab. TTNT is defined as the time from first dose of study drug to the start of subsequent antimyeloma treatment. Email: [emailprotected] The most surprising and disappointing problem I've encountered is the loss of my sense of taste. In the first-in-human phase 1 trial, investigators have set out to examine talquetamab in patients with relapsed/refractory multiple myeloma. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586426. B. Markiewicza, Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Centrum Onkologii Ziemi Lubelskiej im. End of study is defined as last study assessment for last participant in study. PFS2 is defined as the time interval between the date of first dose of study drug and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody. Daratumumab is a human IgG1 monoclonal antibody that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma. experts. 2. Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP) Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication. 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 . This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Overall MRD negative status is defined as percentage of participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.

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