: MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: A first-in-human, multicentre, phase 1 2a trial. Building on the efficacy of immunotherapy, modern immunological treatments such as CAR-T cells or bispecific antibodies are being developed. Accessed February 12, 2022. https://bit.ly/3vcApu4, 28. Most CAR T and BiTE products target BCMA, as does belantamab mafodotin.26 Its a good target, and right now its only being targeted in far-advanced myelomabut its going to be used earlier in the disease course, he said. The phase III MAIA trial (DRd vs. Rd) led to an impressive median PFS of about 5 years with DRd5. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Accessed February 11, 2022.https://seer.cancer.gov/statfacts/html/mulmy.html, 3. The results of the main anti-CD38 phase III trials are presented in Table 1. The treatment of MM has greatly evolved over time, and the recent history of MM has been marked by the advent of multiple novel agents. 1, Virginia Naso 1, Massimiliano Mazza 3, Fabio Nicolini 3, Andrea Ghelli Luserna di Ror 4, Giorgia Simonetti 4, Sonia Ronconi 5, Michela Ceccolini 5, Gerardo Musuraca 5, Giovanni Martinelli 5 and Claudio Cerchione Several other trials are investigating daratumumab and isatuximab in TE patients with NDMM. The anti-CD38 drug class has been extended with the emergence of isatuximab, which exhibits slightly different mechanisms of action from daratumumab. In most countries, anti-CD38 can be regarded as the backbone of most associations of treatments, whether for NDMM TE or NTE and even now in sMM. Immune-based therapies, starting with the emergence of anti-CD38 monoclonal antibodies, whose impact is seen across all groups of patients, are probably the greatest evolution in the field of myeloma so far. Patients ineligible for ASCT might have received Rd for standard-risk disease or a bortezomib-based treatment for intermediate- or high-risk disease.4. 2014;89(6):669. 2023 Mar 23;15(7):1929. doi: 10.3390/cancers15071929. Each therapy is a building block to new treatments. 2021;12:20406207211019612. doi:10.1177/20406207211019612, 15. HHS Vulnerability Disclosure, Help Nov 5, 2022 ONCOLOGY Staff A panel of experts in multiple myeloma discusses recent data updates from 2022 International Myeloma Society Annual Meeting and how it influences treatment strategies in clinical practice. Anderson attributed it to combining classes of drugs like proteasome inhibitors, immunomodulatory drugs (IMiDs), and monoclonal antibodies for newly diagnosed patients and those with relapsed/refractory multiple myeloma. Carfilzomib. : Daratumumab (DARA) Plus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Updated Efficacy and Safety Analysis of the Safety Run-in Population of Griffin. Multiple myeloma (MM), also known as plasma cell myeloma, is a multifocal proliferation of plasma cells based in the bone marrow . Costa LJ, Chhabra S, Callander NS, et al. N Engl J Med. FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma. Patients are living longer than ever before, and the field is taking steps toward defining a functional cure. This is called a pathological fracture. Pomalidomide in the treatment of multiple myeloma: design, development and place in therapy. Accessed February 12, 2022. https://bit.ly/3s8CjtH, 20. Isatuximab is also being investigated in two phase 3 studies: isa-VRd (NCT0367731) and isa-KRd ({"type":"clinical-trial","attrs":{"text":"NCT04483739","term_id":"NCT04483739"}}NCT04483739), both for TE NDMM. Grosicki S, Simonova M, Spicka I, et al. A phase 2 study of modified lenalidomide, bortezomib, and dexamethasone in transplant-ineligible multiple myeloma. These CBD candies offer a simple and flexible . Consultant or advisor for: Adaptive Biotechnologies; Bristol Myers Squibb Company; GlaxoSmithKline; Janssen; Pfizer, Inc.; Regeneron Pharmaceuticals, Inc.; Sanofi; Sutro Biopharma, Inc. Speaker or member of speakers bureau for: Bristol Myers Squibb Company; GlaxoSmithKline; Takeda, Contracted researcher for: Janssen; Sutro Biopharma, Inc.; Takeda, Owns stock (publicly traded) in: Bristol Myers Squibb Company, Consultant or advisor for: AbbVie Inc.; Amgen, Inc.; Bristol Myers Squibb Company; Celgene Corporation; Genentech; GlaxoSmithKline; Janssen; Novartis; Takeda, Research funding from: Bristol Myers Squibb Company; Janssen; Novartis; Takeda, Owns stock (publicly traded) in: TG Therapeutics, Other: Board of Directors for TG Therapeutics, Consultant or advisor for: AbbVie Inc.; Aggios; Amgen, Inc.; AstraZeneca Pharmaceuticals LP; Bristol Myers Squibb Company; Takeda, Speaker or member of speakers bureau for: AbbVie Inc.; Bristol Myers Squibb Company; Takeda, Consultant or advisor for: AbbVie Inc.; Amgen, Inc.; Bristol Myers Squibb Company; Janssen; Karyopharm; Pfizer, Inc.; Sanofi; Takeda, Research funding from: Bristol Myers Squibb Company. Daratumumab has single-agent activity and is potent in pretty much every combination we tested, whether its a proteosome inhibitor or an IMiD or in combination with other immune therapies, Lonial noted. Immunotherapy, since the development of anti-CD38, is a milestone in the treatment of myeloma and has already led to many paradigm shifts. The International Myeloma Working Group updated its diagnostic criteria in 2014 to add validated biomarkers beyond the standard CRAB features (hypercalcemia, renal failure, anemia, and bone lesions) for defining multiple myeloma.6 Additionally, treatment options were added for some patients with smoldering multiple myeloma; patients could be treated earlier, based on their risk of end-organ damage, according to Shaji Kumar, MD, a professor of medicine and consultant for the Division of Hematology at Mayo Clinic in Rochester, Minnesota. Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. CELMoDs are a new IMiD-derived class. Accessed February 12, 2022. https://bit.ly/3tgRTmz, 21. Ongoing studies are investigating their administration in patients with renal impairment. Multiple myeloma,version 4.2022. The phase II DREAMM-2 study introduced BM and led to its approval for RRMM; in that study, the ORR with BM as a single agent was 31% (median PFS of 2.8 months). BM is an encouraging option for patients whose RRMM has been treated with all the anti-MM drug classes. https://pubmed.ncbi.nlm.nih.gov/33662288/, https://pubmed.ncbi.nlm.nih.gov/33067414/. 8600 Rockville Pike Also, the cost of therapy with anti-CD38 mAbs needs to be addressed. Non-immune-based treatments, which were responsible for most successes previously, are not to be completely abandoned. Selinexor (S) is a selective inhibitor of nuclear export (SINE) that targets exportin-1 (XPO1). Non-immune-based treatments, which were responsible for most successes previously, are not to be completely abandoned. Immune-based therapies, starting with the emergence of anti-CD38 monoclonal antibodies, whose impact is seen across all groups of patients, are probably the greatest evolution in the field of myeloma so far. Similarly, the APOLLO study10 showed a median PFS of 12.4 months for the association of daratumumab and third-generation IMiD pomalidomide (P) (DPd), which can be used in R-exposed/refractory patients. Cancer stat facts: myeloma. It uses special drugs that kill fast-growing cells, like multiple myeloma cells. FDA grants accelerated approval to selinexor for multiple myeloma. Updated October 9, 2015. City of Hope Cancer Center The sequencing of anti-CD38 mAbs is being discussed among MM experts and could become a key issue for patients. The role of carfilzomib in relapsed/refractory multiple myeloma. S Vincent Rajkumar 1 Affiliation 1Division of Hematology, Mayo Clinic, Rochester, Minnesota, USA. The supremacy of these types of treatment can be explained by a favorable toxicity profile as well as high efficacy. Novel pathophysiological mechanisms have been unraveled in the past few years, and thus, new targets have been identified, leading to the development of new drugs and new drug classes, such as XPO1 inhibitors and anti-BCL-2. Long-term follow-up results of lenalidomide, bortezomib, and dexamethasone induction therapy and risk-adapted maintenance approach in newly diagnosed multiple myeloma. Has the following relevant financial relationships: Speaker or member of speakers bureau for: Adaptive Biotechnologies; Amgen, Inc.; Bristol Myers Squibb Company; Celgene Corporation; GlaxoSmithKline; Janssen; Pfizer, Inc. Research funding from: Amgen, Inc.; Janssen; Pfizer, Inc. Other: Independent Data Monitoring Committee (IDMC) for safety monitoring for clinical trials: Janssen; Takeda; Theradex, Consultant or advisor for: Bristol Myers Squibb Company; Janssen; Pfizer, Inc.; Takeda, Research funding from: Bristol Myers Squibb Company; Pfizer, Inc.; Takeda. : Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): A randomised, open-label, phase 3 trial. Lonial S, Dimopoulos M, Palumbo A, et al; ELOQUENT-2 Investigators. Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. New anti-CD38 mAbs like MOR2021, which does not activate complement-dependent cytotoxicity mainly responsible for the infusion-related reaction, or TAK-0792, which is presented as highly selective of targeted cells, thus reducing off-target adverse events (AEs) are still surfacing. Multiple myeloma: the (r)evolution of current therapy and a glance into future. and transmitted securely. Tests and procedures used to diagnose multiple myeloma include: Blood tests. Moreau P, Dimopoulos MA, Mikhael J, et al. What follows are the 10 top advances in multiple myeloma from the past decade. sharing sensitive information, make sure youre on a federal 2020 Oct 8;12(10):2885. doi: 10.3390/cancers12102885. 2019; 394(10192): 2938. I think many of us were skeptical that [BiTEs] would be active in myeloma, given that T-cell health may be suboptimal in a refractory myeloma patient population. Chemotherapy is the usual starting point in treating multiple myeloma. HHS Vulnerability Disclosure, Help Clipboard, Search History, and several other advanced features are temporarily unavailable. The current standard induction regimen of lenalidomide, bortezomib, and dexamethasone (RVd)7 and single ASCT for eligible patients, followed by risk-adaptive maintenance, has shown median progression-free survival (PFS) of 65 months for all patients and 76.5 months for standard-risk patients. Multiple myeloma is a plasma cell malignancy that accounts for an estimated 150 000 new cases annually worldwide. He armed himself with a balaclava, latex gloves, condoms . : Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): An open-label, randomised, phase 3 trial. How can initial myeloma therapy be tailored to the individual patient? Lancet Oncol.2014;15(12):e538-e548. ODonnell EK, Laubach JP, Yee AJ, et al. CAR-T, chimeric antigen receptor T; CR, complete response; CRS, cytokine release syndrome; DOR, duration of response; ICANS, immune effector cell-associated neurotoxicity syndrome; MRD, minimal residual disease; ORR, overall response rate; PFS, progression-free survival. La Jolla, California, Director of Judy and Bernard Briskin Multiple Myeloma Center Professor of Hematology/Hematopoietic Cell Transplantation Accessed February 12, 2022. https://bit.ly/3vbmKDp, 14. Surbhi Sidana, MD Stanford University School of Medicine Stanford, CA Larry Anderson, MD, PhD The average remission is around 5 years. What is the optimal approach to treatment for first and second relapse? Photo: Andreas Neumann. Blood. 10.1016/S0140-6736(19)31240-1 Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. 3 The annual age-adjusted incidence in the United States has remained stable for decades at approximately 4 per 100,000. The tour begins on Aug. 3 in Sterling . Careers, Unable to load your collection due to an error. More recently, the results of the CANDOR trial provided a new option for R-refractory patients, a growing part of patients with RRMM, and the association with DKd led to a median PFS of 28.6 months9. In the first-line setting for newly diagnosed MM (NDMM), the phase III multicenter CASSIOPEIA trial3 demonstrated that the association of D, bortezomib (V), thalidomide (T), and dexamethasone (d) could improve the depth of response and progression-free survival (PFS) in comparison with VTd alone in transplant-eligible (TE) patients. FOIA From conventional regimens, based mainly on chemotherapy, to the emergence of immunotherapy, the treatment options are expanding and, consequently, patients survival has improved. Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. She achieved a complete remission with VRd and transplant and was also minimal residual disease (MRD) negative. Dimopoulos MA, Moreau P, Palumbo A, et al; ENDEAVOR Investigators. The .gov means its official. An official website of the United States government. The disease can raise your chances of breaks and other. Theres also a move toward molecular testing with gene sequencing or mutation analysis to determine disease risk, as well as mass spectrometry to determine treatment paths based on protein analyses. The phase III BELLINI trial for patients with RRMM explored the association of venetoclax + Vd versus Vd. Multiple myeloma is a cancer of plasma cells; the incidence rate of multiple myeloma is high among older adults. (iii) The question of retreating patients with anti-CD38 mAbs (i.e., sequencing of anti-CD38) is still unanswered, and possibly the new generations of anti-CD38 mAbs will integrate MM treatments only if they display a higher efficacy than daratumumab/isatuximab or if they allow patients to be retreated with the same class. Multiple myeloma is a plasma-cell neoplasm that is characterized by skeletal destruction, renal failure, anemia, and hypercalcemia. After the encouraging results of the phase II GRIFFIN trial (42.4% of stringent complete response [CR] rate with D-VRd by the end of consolidation)4, the phase III PERSEUS study (ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT03710603","term_id":"NCT03710603"}}NCT03710603) will further investigate the association with D-VRd but will use the second-generation immunomodulatory drug (IMiD) lenalidomide (R) instead of thalidomide. FDA. PMC Nat Rev Clin Oncol.2012;9(3):135-143. doi:10.1038/nrclinonc.2012.15, 6. For instance, the phase III BOSTON trial27 (SVd vs. Vd) showed a median PFS of 13.93 months for SVd versus 9.3 months with Vd (P = 0.0075). Keywords: Lancet Haematol. 10.1016/S1470-2045(21)00466-6 Front Immunol. Accessed February 12, 2022. https://bit.ly/3sUg0as, 13. Graham Head, 66, who kidnapped and tried to rape two women, was caught after one victim remembered three digits of his car registration. FDA. Iberdomide (CC-220) is one of the most advanced CELMoDs so far. The safety issues are marked principally by the frequent occurrence of corneal keratopathy (all grades, 72%) as well as hematological toxicities (thrombocytopenia, 38%). The association of anti-CD38 and VRd for NDMM NTE has also been investigated in the CEPHEUS (dara-VR vs. VRd) study, for which results are also expected. Daratumumab, the first-in-class anti-CD38 mAb, is now followed by the new anti-CD38 generation drug isatuximab (hopefully benefiting patients who have already received this drug class) but has not yet been formally demonstrated in the clinic. The peer reviewers who approve this article are: National Library of Medicine 8600 Rockville Pike Weve been trying to do that for 15 years, and it continues to survive and thrive even in the context of new treatments. That is because every trial comparing transplant to no transplant, even with new drugs, has shown that transplant deepens the response and offers significant benefits, he said. The site is secure. The safety profiles of CAR-T cells and BsAbs are relatively similar as they both lead to an immune reaction of the host, CRS, or neurotoxicity, though to a lesser extent globally. Updated Results from MajesTEC-1: Phase 1/2 Study of Teclistamab, a B-Cell Maturation Antigen x CD3 Bispecific Antibody, in Relapsed/Refractory Multiple Myeloma. Moreau P, Masszi T, Grzasko N, et al; TOURMALINE-MM1 Study Group. Recent advances in the treatment and outcomes of multiple myeloma led to the implementation of new response criteria, including minimal residual disease (MRD) status as one of the most. BiTEs are not yet FDA approved but look promising. The median PFS was approximately double for carfilzomib/dexamethasone compared with bortezomib/dexamethasone at 18.7 months vs 9.4 months, respectively (HR, 0.53; 95% CI, 0.44-0.65; P < .0001).15. Accessed February 12, 2022. https://bit.ly/3h865Zj, 8. Our experts provide practical guidance. CAR-T cells and BsAbs have their own specificities despite having apparent similar efficacy and safety profiles. Elotuzumab therapy for relapsed or refractory multiple myeloma. The authors declare that they have no competing interests.Dr Hari has collaborated with Dr Leleu on a large paper in March 2021: https://pubmed.ncbi.nlm.nih.gov/33662288/Dr Morgan has collaborated with Dr Leleu on a large paper in October 2020: https://pubmed.ncbi.nlm.nih.gov/33067414/, MeSH over the past several years, resulting in significantly improved outcomes for these patients. The most recent developments with anti-CD38 are based on (i) the objective to combine anti-CD38 with other novel drugs and mechanisms of action to improve the depth of response and particularly the MRD-negative rate and (ii) the focus on MRD to tailor the treatments; in that regard, the phase II MASTER trial provided an interesting induction therapy with D-carfilzomib (K)-Rd (80% MRD 105 negativity overall and 66% MRD 106 negativity)13. The use of dexamethasone and prophylactic antiemetics is almost always necessary because of GI toxicity. Importantly, the main difference with CAR-T cells is that they are antibody (structure)-based and do not require lymphocytes to be apheresed from the patient and thus can be used off-the-shelf, which allows faster delivery. BGB-11417 is being evaluated in a phase 1b/2 study in MM ({"type":"clinical-trial","attrs":{"text":"NCT04973605","term_id":"NCT04973605"}}NCT04973605). Plasma cells normally produce antibodies that help fight infection, but when they become cancerous, they can damage various organs of the body such as kidneys and bones. FDA. The authors declare that no grants were involved in supporting this work. The first-in-human multicohort phase I/II trial (CC-220-MM-001) with iberdomide for RRMM determined the RP2D to be 1.6 mg22. Usage of the subcutaneous formulation became especially important during the COVID-19 pandemic, when oncologists sought to reduce the number of office visits to safeguard patients health. With CAR-T cells, the main toxicity is the cytokine release syndrome (CRS) that develops after CAR-T cell infusion (median of 1 day with ide-cel and 7 days with cilta-cel studies). If you put the RVd and daratumumab before and after a transplant, you can get minimal residual disease [MRD]negative responses in 70% of patients, which is quite remarkable, and that does correlate with much better outcomes, Anderson said.9, RVd lite is a modified regimen with a lower dose of lenalidomide, which also has high response rates and a long PFS, with a favorable adverse event profi le for nontransplant candidates, Anderson said. . Soon, it may be an FDA-approved therapy. Queens of the Stone Age will bring Phantogram, Viagra Boys, the Armed, and Savages' Jehnny Beth on their fall North American tour. News release. Ixazomib is advantageous as an oral agent, with the phase 3 TOURMALINE-MM1 trial (NCT01564537) showing a PFS advantage for oral ixazomib plus lenalidomide/dexamethasone vs lenalidomide/dexamethasone alone (20.6 months vs 14.7 months, respectively; HR, 0.74; P = .01) in patients with relapsed/ refractory disease.16 Although patients can get some peripheral neuropathy, recent clinical trials show it is not as potent as with some other proteosome inhibitors,17 Kumar noted. : 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. Triplet and quadruplet treatments can achieve MRD negativity in patients with newly diagnosed and relapsed/refractory multiple myeloma, he noted, and a durable response correlates with marked PFS and OS advantages. Final Overall Survival Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma. 2017 Jan;37(1):129-143. doi: 10.1002/phar.1871. Unauthorized use of these marks is strictly prohibited. Accessibility Inclusion in an NLM database does not imply endorsement of, or agreement with, Revised International Staging System for multiple myeloma: A report from International Myeloma Working Group. Pomalidomide was approved in 2013 as a second-generation IMiD that can overcome resistance to lenalidomide and thalidomide (Thalomid).23 In the phase 3 NIMBUS/MM-003 trial (NCT01311687) that enrolled patients with relapsed/refractory multiple myeloma and at least 2 prior therapies, pomalidomide and low-dose dexamethasone showed an improved PFS compared with high-dose dexamethasone (4.0 months vs 1.9 months, respectively; HR, 0.48; 95% CI, 0.39-0.60; P < .0001).24, In the past decade, patients with multiple myeloma benefi ted from development and approvals in other treatment classes, including antibody-drug conjugates (ADC), nuclear transport inhibitors, and IMiDs. The final analysis of the study24 (median follow-up of 45.6 months) showed a median PFS of 23.4 months in the venetoclax group versus 11.4 months in the Vd group (P = 0.010). Mahindra A, Laubach J, Raje N,Munshi N, Richardson PG, Anderson K. Latest advances and current challenges in the treatment of multiple myeloma. Published correction appears in Am J Hematol.2012;87(4):452. 1.25 CE Advances in Multiple Myeloma Navigating the Evolving Treatment Landscape Rapid Fire Emerging Data in Multiple Myeloma For that reason, the development of drugs using novel mechanisms or new targets is still encouraged. 1Department of Hematology, University Hospital of Poitiers, 2 rue de la Miltrie, CHU de Poitiers, Poitiers, France. According to Binod Dhakal, MD, ciltacabtagene autoleucel may become a new standard therapy for patients with lenalidomide (Revlimid)-refractory multiple myeloma. The anti-BCL-2 agents represent the first biomarker-driven strategy in MM. The recent history of multiple myeloma has been marked by tremendous advances in the treatments available, which have ultimately improved the patients' survival. Krishnan AY, Minnema MC, Berdeja JG, et al. The development of immunotherapies is certainly the greatest evolution that has happened in the field of MM recently. When cancerous plasma cells multiply, they can overcrowd healthy cells within your bone marrow like weeds crowding out healthy plants and cause complications. 30 min The Nurse View: Bringing Multiple Myeloma Into Focus Explore the crucial roles nurses play in the complex care of patients with multiple myeloma (MM), including clinical application of the latest therapies. Cilta-cel was evaluated in the phase I/II CARTITUDE-1 study; the ORR was 97.9%, 80.4% of patients had a CR, and 18-month PFS was 66% (median follow-up of 12.4 months)17. Overall, anti-CD38 mAbs are finding their way into frontline therapy, especially in Europe, where they are already recommended for nearly all TE and NTE patients, whereas in the US, they tend to be reserved for some selected patients for now. Nevertheless, myeloma remains an incurable disease and diversified options are still required, notably for heavily pretreated patients. 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