March 12, 2021. Drug Therapy for Multiple MyelomaAbout Relapsed/Refractory Multiple Myeloma | POMALYST ... Ehsan Malek, MD, assistant professor, Department of Medicine, School of Medicine, member, Immune Oncology Program, Case Comprehensive Cancer Center, physician, Department of Hematology and Oncology, University Hospitals Cleveland Medical Center, discussed making a treatment decision for a patient with relapsed or refractory multiple myeloma. Advances for Patients With Relapsed/Refractory Multiple ... In this phase 1 study, patients with relapsed/refractory MM received venetoclax monotherapy. Relapsed/Refractory Multiple Myeloma Updates from ASH 2021. 3 , 4 Bhavesh Shah, RPh, BCOP: Hello and welcome to this Directions in Oncology Pharmacy® Peer Exchange. Karyopharm's Partner Antengene Receives Approval in China ...Relapsed and Refractory Myeloma Defined - The Myeloma CrowdRelapsed/Recurrent Multiple Myeloma: Symptoms, Causes ...Subclone-specific microenvironmental impact and drug ... As it progresses, bone pain, anemia, kidney dysfunction, and infections may occur. . Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. 2017; 111:87-93. Carfilzomib, dexamethasone, and daratumumab versus ... In this randomised, multicentre, open-label, phase 3 study, 466 patients recruited from 102 sites across North America, Europe, Australia, and Asia with relapsed or refractory multiple myeloma were randomly assigned 2:1 to carfilzomib, dexamethasone, and daratumumab (KdD) or carfilzomib and dexamethasone (Kd). The diagnosis of relapsed or refractory multiple myeloma depends on bone marrow tests and markers that can be detected in blood and sometimes in urine, all in addition to any signs and symptoms that may be present. last year . Uncovering novel targets for therapeutic intervention is imperative for the treatment of patients that have depleted all currently available treatment options. Dr. Saad Usmani is joined by Dr. Sham Mailankody to discuss cellular therapy in Relapsed/Refractory Multiple Myeloma. 1,3,4 Furthermore, patients with relapsed and refractory multiple myeloma (RRMM) may have comorbidities . Complications may include amyloidosis.. Nina Shah, MD. D-Vd is a combination approved in relapsed-refractory multiple myeloma (RRMM) after 1-3 prior lines of therapy. Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, showed deep, durable responses in patients with triple-class exposed (TCE) relapsed and refractory multiple myeloma (RRMM) in the phase 2 KarMMa trial. Leukemia. Patients inevitably experience relapse or develop resistance to initial multidrug combinations in spite of high complete response (CR) rates. For Immediate Release: July 03, 2019. Though treatable, multiple myeloma (MM) remains incurable. EP. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma Ide-cel induced responses in a majority of heavily pretreated patients with refractory and relapsed myeloma; MRD-negative status was achieved in 26% of treated patients. In Multiple Myeloma Today's roundtable series discussing research presented at ASH 2021, moderator Dr. Saad Usmani is joined by Dr. Sham Mailankody to discus. In this video, Sham Mailankody highlights PFS findings in cell-to-cell therapy and his own GPRC5D study, looking at a new target for CAR T-cell therapy in myeloma. In this segment, Krina Patel, MD, MSc, of MD Anderson, joins Patient Power co-founder Andrew Schorr to discuss making informed treatment decisions for relapsed/refractory multiple myeloma patients, the future of CAR T-cell therapy and how it may affect the role of transplants, and promising data on bispecific antibodies. Pomalidomide plus low dose dexamethasone is active and well tolerated in bortezomib and lenalidomide refractory multiple myeloma: IFM 2009-02. Presented at: The European Hematology Association 25th Annual Congress, June 11-21, 2020. Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, showed deep, durable responses in patients with triple-class exposed (TCE) relapsed and refractory multiple myeloma (RRMM) in the phase 2 KarMMa trial. The CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel; JNJ-68284528) led to a high response rate and an acceptable safety profile at the recommended phase 2 dose in patients with relapsed or refractory multiple myeloma, according to findings from the CARTITUDE-1 trial (NCT03548207) that were presented during the 2020 ASH Annual Meeting. But other factors , such as the tumor's cytogenetics (chromosome changes), the levels of certain proteins and other substances in the blood, your kidney function, your age and overall health, can also affect your outlook. 1. Gandhi UH, Cornell RF, Lakshman A, Gahvari ZJ, McGehee E, Jagosky MH, et al. If it doesn't respond to treatment or comes. 1: Breakthroughs in Therapeutic Options for Relapsed/Refractory Multiple Myeloma. Most patients with relapsed/refractory multiple myeloma (RRMM) have been treated with drug combinations including a proteasome inhibitor (PI) and/or an immunomodulatory drug (IMiD). The cause of multiple myeloma is unknown. A Study in Subjects With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Isatuximab plus carfilzomib and dexamethasone vs carfilzomib and dexamethasone in relapsed/refractory multiple myeloma (IKEMA): interim analysis of a phase 3, randomized, open-label study. Discover what relapsed multiple myeloma is. High response rate to bortezomib with or without dexamethasone in patients with relapsed or refractory multiple myeloma: results of a global phase 3b expanded access program Br J Haematol , 144 ( 2009 ) , pp. ABSTRACT. March 11, 2021. Online ahead of print. This activity is provided by the Annenberg Center for Health Sciences at Eisenhower and developed in partnership with Clinical Care Options, LLC and the International Myeloma Foundation. RTTNews . EP. Antengene Receives Approval In China For XPOVIO For Treatment Of Refractory Multiple Myeloma . December 22, 2021. Immunotherapy for the treatment of multiple myeloma. Novel immunomodulators, proteasome inhibitors, monoclonal antibodies, histone deacetylase inhibitors, and nuclear export inhibitors have all been added to the armamentarium, and the choice of which of these drugs or drug combinations to use depends on . How to Treat Relapsed/Refractory Multiple Myeloma in 2020 . Multiple myeloma is clinically and pathologically heterogeneous, which results in variability in treatment response and survival. Patients with so-called triple-class refractory multiple myeloma have poor survival, substantial hospitalizations, and a clinically meaningful decline in health-related quality of life, according . In July 2019, the FDA granted an accelerated approval to the selinexor combination for use in adult patients with relapsed/refractory multiple myeloma who received 4 or more prior therapies and . 1 The objective response rate (ORR) was 96.9% . Moreau P, Dimopoulos MA, Mikhael J, et al. 1: Breakthroughs in Therapeutic Options for Relapsed/Refractory Multiple Myeloma. Nina Shah, MD, discusses how to properly navigate treatment plans for patients with relapsed/refractory multiple myeloma. The majority of patients with multiple myeloma (MM) will have an initial response to treatment with modern combination regimens. doi: 10.1182/bloodadvances.2021005913. Patients with triple-class refractory multiple myeloma (TCR MM) experienced poor survival, significant hospitalizations, and a clinically meaningful decline in health-related quality of life (HRQoL), according to data from the Connect MM Disease Registry presented at the American Society of Hematology's 2021 Annual Meeting and Exposition. Treatment with a subcutaneous formulation of teclistamab, a novel bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 receptors, was well tolerated and associated with durable responses in patients with relapsed or refractory multiple myeloma (MM), according to findings from a phase I study. Critical Reviews in Oncology/Hematology. Deepu Madduri, MD: Let's talk about the landscape for relapsed/refractory multiple myeloma [RRMM].Patients typically are given PIs [proteasome inhibitors], IMiDs [immunomodulatory imide drugs . Clinical trial shows preliminary efficacy of all-oral regimen for patients with lenalidomide-refractory multiple myeloma Download PDF Copy Reviewed by Emily Henderson, B.Sc. Relapsed/Refractory Multiple Myeloma Updates from ASH 2021. Dr. Saad Usmani is joined by Dr. Sham Mailankody to discuss cellular therapy in Relapsed/Refractory Multiple Myeloma. Myeloma is the fifteenth leading cause of cancer death in the United States. Nina Shah, MD, discusses how to properly navigate treatment plans for patients with relapsed/refractory multiple myeloma. Selinexor, which is an exportin-1 (XPO1) inhibitor, is also approved in combination . Despite the availability of proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies for multiple myeloma, most patients will have a relapse and refractory disease will develop. The death rate was 3.2 per 100,000 men and women per year based on 2015-2019 deaths, age-adjusted. Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease . Blood 2001; 98:492. : Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. In this video, Sham Mailankody highlights PFS findings in cell-to-cell therapy and his own GPRC5D study, looking at a new target for CAR T-cell therapy in myeloma. Often, no symptoms are noticed initially. Blood Adv. This Phase 2, randomized, open-label study evaluated 117 patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy, including REVLIMID and a proteasome inhibitor, and were refractory to their most recent therapy. Dec 21 2021 Selinexor is approved by the U.S. FDA for the treatment of relapsed/refractory multiple myeloma (RRMM), second line multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. Relapsed/Refractory Multiple Myeloma: Disease Overview. Barlogie B, Desikan R, Eddlemon P, et al. In addition, some patients will not respond to initial treatment (ie, refractory disease). Relapsed/Refractory Multiple Myeloma Landscape Relapsed/Refractory Multiple Myeloma Landscape November 12, 2021 Kenneth H. Shain, MD, PhD Kenneth Shain, MD, PhD provides an overview of recent. Blood Adv. DIAGNOSTIC APPROACH IN RELAPSE AND REFRACTORY MULTIPLE MYELOMA Several diagnostic procedures should be undertaken for patients with RRMM, including serum and urine protein electrophoresis and immunofixation, urine total protein, serum-free light chain, serum beta-2-microglobulin, and serum lactate dehydrogenase (LDH) tests. Indatuximab ravtansine with lenalidomide or pomalidomide shows encouraging clinical activity for relapsed or refractory multiple myeloma, according to data from a phase 1/2a study published in the. Despite the availability of new treatments, most patients with multiple myeloma will become refractory to the therapies that currently comprise the hematologic standard of care for the malignancy, including proteasome inhibitors, immunomodulatory agents, and . FDA approves new treatment for refractory multiple myeloma. Triple-class refractory Introduction Multiple myeloma (MM), characterized by the expansion of malignant plasma cells in the bone marrow, 1 accounts for ∼1% of all malignancies and 10% of hematologic malignancies. Explore relapsed multiple myeloma, from the definition of relapse to support that may help you on your journey. Multiple myeloma (MM) is a hematological malignancy that remains incurable because most patients eventually relapse or become refractory to current treatments. Cilta-Cel Produces 'Durable and Deep' Responses in Relapsed/Refractory Multiple Myeloma Andrea S. Blevins Primeau, PhD, MBA The stringent complete response rate increased from 67% at 1 year to 83%. 169 - 175 , 10.1111/j.1365-2141.2008.07409.x If you have multiple myeloma, there's a good chance it will come back after successful treatment. Refractory Myeloma Dr. Damian Green, MD of the Fred Hutchinson Cancer Center, generally defines Refractory Myeloma as "disease that is progressing despite active treatment." The National Cancer Institute breaks it down even further to say that there are two main types of refractory myeloma patients: 1. With so many recent advances in relapsed/refractory multiple myeloma, keeping abreast with current treatment recommendations can be challenging. Authored by the world's top myeloma experts, this manuscript analyzes the results of phase II and III clinical trials and creates a rational approach to therapy. 66. Today, the U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor . Despite emerging therapies for the treatment of relapsed or refractory (R/R) multiple myeloma (MM; RRMM) improving patient prognosis considerably, caveats remain. Hear patients talk about their experiences with relapsed multiple myeloma. In part 2 of Multiple Myeloma Today's roundtable series discussing Relapsed/Refractory Multiple Myeloma, moderator Dr. Saad Usmani and Dr. Cesar Rodriguez di. Online ahead of print. 41,42 For a specific subgroup of patients, the efficacy of the anti-Bcl-2 inhibitor venetoclax in patients with t . 2019. Explore relapsed multiple myeloma, from the definition of relapse to support that may help you on your journey. doi: 10.1182/bloodadvances.2021005913. 2013;121(11):1968-1975. Clonal evolution of MM cells and bone marrow microenvironment changes contribute to drug resistance. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Relapsed/refractory MM (RRMM) is defined as a disease which becomes non-responsive or progressive on therapy or within 60 days of the last treatment in patients who had achieved a minimal response (MR) or better on prior therapy.7 Indications for relapse treatment Navigating Individual Treatment for Relapsed/Refractory Multiple Myeloma. Allogene Therapeutics Reports Positive Results from Phase 1 UNIVERSAL Study of Single Dose ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 63rd American Society of Hematology Annual Meeting - read this article along with other careers information, tips and advice on BioSpace A historical review of treatment advances in relapsed/refractory multiple myeloma and criteria used to define relapsed or refractory disease. The addition of isatuximab to pomalidomide-dexamethasone significantly improves progression-free survival in patients with relapsed and refractory multiple myeloma. Relapsed/refractory multiple myeloma (RRMM) is accompanied by the clonal evolution of myeloma cells with heterogeneous genomic aberrations and profound changes of the bone marrow microenvironment. ICHNOS SCIENCES PRESENTS PRECLINICAL DATA ON NOVEL ISB 1442 IN RELAPSED/REFRACTORY MULTIPLE MYELOMA AT THE ASH 2021 ANNUAL MEETING ISB 1442 is a First-In-Class 2+1 Biparatopic Bispecific BEAT® 2 . Refractory means. The goal of therapy for such patients is therefore to achieve disease control with acceptable toxicity and patient-defined decent quality of life. Teclistamab is currently being evaluated in a Phase 2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT04557098) and is also being explored in combination studies (NCT04586426, NCT04108195, NCT04722146). Patients were randomized to receive either the triplet regimen or the doublet. In triple-class refractory multiple myeloma, an ORR of 27% was reported with the combinations of selinexor/dexamethasone 39 and melflufen/dexamethasone 40; an ORR of approximately 40% was observed with belamaf as a single agent. FDA approves selinexor for refractory or relapsed multiple myeloma. Multiple myeloma is a cancer that affects a type of white blood cell called a plasma cell, which helps your immune system fight infections. Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and bortezomib 1.3 mg/m^2 on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward (Maximum of 8 cycles in those who have previously received bortezomib) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1 . High rates of deep and durable responses were observed among patients with relapsed/refractory multiple myeloma with or without t(11;14) translocation who were treated with venetoclax (Venclexta) with daratumumab (Darzalex) and dexamethasone (VenDd) and VenDd with bortezomib (VenDVd), according to data from a phase 1 study (NCT03314181) published in the Journal of Clinical Oncology. 2. The growing number of novel agents holds increasing promise of benefit for patients who relapse and/or become refractory to therapy, but improving the prognosis for these patients requires . In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory . Jung SH, et al. The disease trajectory varies for each patient, but relapses are inevitable and many patients become refractory to treatments. In July 2019, the FDA granted an accelerated approval to the selinexor combination for use in adult patients with relapsed/refractory multiple myeloma who received 4 or more prior therapies and . Tests carried out include: The percent of myeloma deaths is highest among people aged 75-84. When this happens, it's called recurrent or relapsed. Dec. 17, 2021, 08:44 AM Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy. Thalidomide in multiple myeloma--from the clinic to the laboratory. In heavily pretreated relapsed/refractory multiple myeloma cell lines with t (11;14), selinexor (Xpovio) combined with venetoclax (Venclexta) demonstrated efficacy and tolerability, according to small study results that were presented during the 2021 ASH Annual Meeting. Although the treatments have improved, the major problem in MM is resistance to therapy. Relapsed Refractory Multiple Myeloma & The Elderly Patient. Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients. After each relapse, treatment regimens result in progressively lower response rates, shorter response durations, and increasing drug resistance, thereby diminishing the number of treatment options. Leleu X, Attal M, Arnulf B, et al. Patients with so-called triple-class refractory multiple myeloma have poor survival, substantial hospitalizations, and a clinically meaningful decline in health-related quality of life, according . In adults who have received two or more previous multiple myeloma treatments that included lenalidomide and a proteasome inhibitor, which is a type of drug. 2021 Dec 21:bloodadvances.2021005913. Survival rates for myeloma are generally based on if a single plasmacytoma is found or if multiple myeloma is diagnosed. ABSTRACT. 2021 Dec 21:bloodadvances.2021005913. Primary refractory patients who never achieve a response and progress while still on induction chemotherapy (or their myeloma never responded to treatment initially). 2 In the past decades, the advent of new, more effective, and less toxic therapies has revolutionized the management of MM. December 22, 2021. CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multi-center study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, including 99 percent who were refractory to the last line of treatment and 88 percent of who were triple-class refractory, meaning their cancer did not . Nina Shah, MD. Listing a study does not mean it has been evaluated by the U.S. Federal Government. In this segment, Krina Patel, MD, MSc, of MD Anderson, joins Patient Power co-founder Andrew Schorr to discuss making informed treatment decisions for relapsed/refractory multiple myeloma patients, the future of CAR T-cell therapy and how it may affect the role of transplants, and promising data on bispecific antibodies. What Is Refractory Multiple Myeloma? For multiple myeloma (MM) patients who are refractory to proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 agents, the prognosis is poor. 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