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On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...
As reported in The Lancet Oncology by Paul G. Richardson, MD, and colleagues, a prespecified interim overall survival analysis of the phase III ICARIA-MM trial showed that the addition of isatuximab to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma produced...
The ASCO Post asked Joseph Mikhael, MD, Chief Medical Officer of the International Myeloma Foundation and Professor in the Applied Cancer Research and Drug Discovery Division at the Translational Genomics Research Institute (an affiliate of City of Hope Cancer Center), to comment on the GMMG-HD7...
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
The ASCO Post invited myeloma expert Philip L. McCarthy, MD, Director of the Transplant and Cellular Therapy Program at Roswell Park Comprehensive Cancer Center, Buffalo, New York, to comment on the trials evaluating early detection of myeloma at the 2021 American Society of Hematology (ASH) Annual ...
Precursors to multiple myeloma were identified by population screening in two studies reported at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. The prevalence of monoclonal gammopathies was determined in the PROMISE trial using cutting-edge technology in a high-risk ...
Ajay K. Nooka, MD, MPH, FACP, Associate Professor in the Department of Hematology and Medical Oncology at Winship Cancer Institute, Emory University, Atlanta, commented on the promising emergence of bispecific T-cell engaging (bispecific) antibodies, as represented by studies presented at the 2021...
Poor outcomes are observed in patients with myeloma who are refractory to multiple classes of therapies, with the average patient experiencing disease progression in up to 6 months and living no longer than 6 to 15 months. Patients often rapidly cycle through regimens that use less effective or...
An updated analysis of the phase III CANDOR study—recently reported by Usmani et al and summarized in this issue of The ASCO Post—confirmed a significant progression-free survival benefit for the combination of daratumumab, carfilzomib, and dexamethasone (KdD) over carfilzomib and dexamethasone...
In an updated analysis of the pivotal phase III CANDOR trial reported in The Lancet Oncology, Saad Z. Usmani, MD, of Levine Cancer Institute/Atrium Health, and colleagues found that the addition of daratumumab to carfilzomib and dexamethasone (KdD) continued to show a large progression-free...
On November 30, 2021, daratumumab/hyaluronidase-fihj and carfilzomib were approved for use in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who had one to three prior lines of therapy.1,2 Supporting Efficacy Data Approval was based on findings in a cohort...
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
The ASCO Post invited myeloma expert Philip L. McCarthy, MD, Director of the Transplant and Cellular Therapy Program at Roswell Park Comprehensive Cancer Center, Buffalo, New York, to comment on the trials evaluating early detection of myeloma at the 2021 American Society of Hematology (ASH) Annual ...
Precursors to multiple myeloma were identified by population screening in two studies reported at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. The prevalence of monoclonal gammopathies was determined in the PROMISE trial using cutting-edge technology in a high-risk ...
Proteasome inhibitors, the therapeutic backbone of current treatments for multiple myeloma, are effective in treating newly diagnosed disease, but resistance or intolerance to these molecules often develops, leading to relapse. While studying a neglected tropical disease, Buruli ulcer, researchers...
Romanos Sklavenitis-Pistofidis, MD, of Dana-Farber Cancer Institute, discusses study findings on a next generation of clinical assays to assess both tumor biology and immune state, as well as common clinical biomarkers in the marrow or blood. These biomarkers may accurately predict which patients with smoldering multiple myeloma might benefit from early treatment, monitor response to immunotherapy, and improve patient outcomes (Abstract 330).
Anil Aktas-Samur, PhD, of Dana-Farber Cancer Institute, discusses study findings on the genomic characterization of non-progressor smoldering multiple myeloma, results that may provide a molecular definition of the disease as well as its risk-driving features. Combining this low-risk model with current high-risk models may possibly improve clinical trials for patients with this early precursor to myeloma (Abstract 545).
Nikhil C. Munshi, MD, PhD, of Dana-Farber Cancer Institute, discusses the findings from a large nationwide Veterans Affairs study, which showed that, for patients with multiple myeloma, the effectiveness of the COVID-19 vaccine is reduced, likely due to patients’ immunosuppression. Dr. Munshi describes what next steps should be taken (Abstract 400).
In the phase II MASTER trial reported in the Journal of Clinical Oncology, Luciano J. Costa, MD, PhD, and colleagues found that daratumumab, carfilzomib, lenalidomide, and dexamethasone (Dara-KRd) induction; autologous hematopoietic cell transplantation (AHCT); and measurable residual disease (MRD) ...
Molecular and genetic research has advanced the categorization of different risk groups in patients with smoldering myeloma. Notable presentations at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition included reports on biomarkers to predict response to immunotherapy in...
In the past decade, use of immunotherapy has arisen as a novel adjunct to multiple myeloma therapy. Daratumumab is the first anti-CD38 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA), in November 2015, for use in treating relapsed or refractory multiple myeloma.1...
As reported in The Lancet Oncology by Thierry Facon, MD, of the Centre Hospitalier Universitaire de Lille, and colleagues, a prespecified interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to...
In an updated analysis of the pivotal phase III CANDOR trial reported in The Lancet Oncology, Saad Z. Usmani, MD, and colleagues found that the addition of daratumumab to carfilzomib and dexamethasone (KdD) continued to show a large progression-free survival benefit in patients with relapsed or...
Tarek H. Mouhieddine, MD, of The Mount Sinai Hospital and The Icahn School of Medicine at Mount Sinai, discusses data that suggest patients with heavily pretreated, predominantly triple-class refractory multiple myeloma who relapse after treatment with bispecific antibodies may still have good outcomes when sequentially treating with other immunologic treatments (Abstract 821).
For the first-line treatment of newly diagnosed, transplant-eligible patients with multiple myeloma, the achievement of measurable residual disease (MRD) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to the standard three-drug induction regimen of...
In a U.S. cohort study reported in JAMA Network Open, Wang et al found that fully vaccinated patients with multiple myeloma were at increased risk of breakthrough SARS–CoV-2 infection, and that those with breakthrough infection were more likely to be hospitalized vs fully vaccinated persons without ...
Patients with multiple myeloma lacking an antibody response to COVID-19 vaccination may also fail to mount a T-cell response, researchers from the Icahn School of Medicine at Mount Sinai have reported. This scenario seemed to be most common among patients actively treated with anti-CD38 and...
In the Italian phase II FORTE trial reported in The Lancet Oncology, Francesca Gay, PhD, and colleagues found that induction therapy with carfilzomib, lenalidomide, and dexamethasone (KRd) produced a higher response rate vs carfilzomib, cyclophosphamide, and dexamethasone (KCd) among patients aged...
On November 30, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with carfilzomib (Kyprolis) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of...
Bortezomib, thalidomide, and dexamethasone (VTd) is an acceptable, effective standard-of-care induction treatment in Europe for patients with newly diagnosed myeloma who are eligible for autologous stem cell transplantation. CASSIOPEIA is a two-part, open-label, randomized, phase III trial in...
As reported in The Lancet Oncology by Philippe Moreau, MD, of the University Hospital Hôtel-Dieu, Nantes, and colleagues, an interim analysis of part 2 of the phase III CASSIOPEIA trial has showed significantly prolonged progression-free survival with maintenance daratumumab vs observation...
“Continuous improvement is better than delayed perfection.” —Mark Twain To complement The ASCO Post’s extensive coverage of the 2021 ASCO Annual Meeting, here are several abstracts selected from the meeting proceedings focusing on novel treatments under study in high-risk multiple myeloma. For...
Researchers have developed a new model that uses DNA and RNA sequencing data from hundreds of patients to identify specific genes and genetic alterations responsible for subtypes of multiple myeloma. They also identified potential targeted treatments based on the findings, which were reported by...
Shaji K. Kumar, MD, of the Mayo Clinic Cancer Center, discusses the evolving treatment paradigm for patients with newly diagnosed multiple myeloma in which clinical trials are suggesting the addition of a fourth drug to induction treatment regimens and new drug classes are improving treatment for those not eligible for transplantation.
Patients with multiple myeloma lacking an antibody response to COVID-19 vaccine may also fail to mount a T-cell response, according to research from the Icahn School of Medicine at Mount Sinai. Concerningly, this scenario was most common among patients actively treated with anti-CD38 and...
On October 22, Oncopeptides announced its decision to withdraw melphalan flufenamide (Pepaxto), a first-in-class peptide-drug conjugate, from the market in the United States, following results from the phase III OCEAN study in patients with relapsed or refractory multiple myeloma. The decision to...
As reported in The Lancet Oncology by Thierry Facon, MD, and colleagues, an interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to lenalidomide/dexamethasone in newly diagnosed, transplant-ineligible patients with ...
In a single-center phase II trial reported in JAMA Oncology, Kazandjian et al found that triplet therapy with carfilzomib, lenalidomide, and dexamethasone (KRd), followed by lenalidomide maintenance, produced high rates of measurable residual disease (MRD)-negative complete response and freedom...
As reported in The Lancet Oncology by Philippe Moreau, MD, and colleagues, an interim analysis of part 2 of the phase III CASSIOPEIA trial has shown significantly prolonged progression-free survival with maintenance daratumumab vs observation following induction and consolidation with or without...
Saad Z. Usmani, MBA, MD, of the Levine Cancer Institute, discusses new data on the CAR T-cell therapy ciltacabtagene autoleucel, a single infusion of which yielded early, deep, and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma (Oral Abstract MM-119).
In a phase III European Myeloma Network trial (EMN02/HOVON95) reported in the Journal of Clinical Oncology, Sonneveld et al found that consolidation with bortezomib, lenalidomide, and dexamethasone (VRD) vs no consolidation followed by maintenance lenalidomide was associated with significantly...
For the challenging population of patients with multiple myeloma who have become refractory to essentially all current treatments, new approaches are much needed. Early clinical trials data suggest bispecific antibodies may help meet this need, as suggested by studies presented at the 2021 ASCO...
The treatment paradigm for multiple myeloma continues to evolve at a rapid pace with the introduction of new drugs and the development of drug combinations, particularly the initial approach to the treatment of newly diagnosed multiple myeloma.1 One major shift in the treatment of newly diagnosed...
As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous (SC) daratumumab to oral...
On July 9, 2021, daratumumab and hyaluronidase-fihj was approved for use in combination with pomalidomide and dexamethasone (Pd) for treatment of adults with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.1 Supporting...
In a phase I study reported in the Journal of Clinical Oncology, Bahlis et al found that venetoclax plus daratumumab/dexamethasone (VenDd) and VenDd with bortezomib (VenDVd) produced high rates of durable responses in patients with relapsed or refractory multiple myeloma with t(11;14) translocation ...
Muhamed Baljevic, MD, of the University of Nebraska Medical Center, reviews the outlook for treating patients with relapsed and refractory multiple myeloma, the rapidly expanding array of therapeutic options with novel mechanisms of action, and the challenges of sequencing treatments.
Muhamed Baljevic, MD, of the University of Nebraska Medical Center, reviews the outlook for treating patients with relapsed and refractory multiple myeloma, the rapidly expanding array of therapeutic options with novel mechanisms of action, and the challenges of sequencing treatments.
On March 31, 2021, the anti-CD38 monoclonal antibody isatuximab-irfc was approved for use in combination with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.1 Supporting Efficacy Data...
Nina Shah, MD, of the University of California, San Francisco, discusses triplet drug combinations that are the current standard of care for transplant-eligible and -ineligible patients with multiple myeloma, as well as quadruplet therapies that demonstrate depth of response in newly diagnosed cases, where they may become the standard of care along with transplantation and maintenance treatments.