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Patients with multiple myeloma now have access to an all-oral regimen, with the recent approval of the oral proteasome inhibitor ixazomib (Ninlaro) in previously treated patients. New pairings for the drug in relapsed/refractory and newly diagnosed patients are being studied, with investigators...
Sagar Lonial, MD, of Winship Cancer Institute, offers his thoughts on abstract 79, “Carfilzomib, Lenalidomide, and Dexamethasone vs Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma: Interim Results From ASPIRE, a Randomized, Open-Label, Multicenter Phase III Study,” presented by A. Keith Stewart, MD.
Sagar Lonial, MD, of Winship Cancer Institute, offers his thoughts on abstract 302, “Final Results for the 1703 Phase Ib/II Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma,” presented by Paul G. Richardson, MD; abstract 84, “Safety and Efficacy of Daratumumab With Lenalidomide and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma,” presented by Torben Plesner, MD; and “A Phase Ib Dose Escalation Trial of SAR650984 (Anti–CD-38 mAb) in Combination With Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma,” presented by Thomas G. Martin III, MD.
Kenneth C. Anderson, MD, of Dana-Farber/Brigham and Women’s Cancer Center, discusses the incredible progress made in treating multiple myeloma, with nine therapeutic options approved in the past decade, two drugs approved this year, and a number of new options on the horizon.
James O. Armitage, MD, of the University of Nebraska Medical Center, and Sagar Lonial, MD, of Emory University School of Medicine, discuss results from two important studies that tested lenalidomide/dexamethasone with or without elotuzumab and daratumumab monotherapy (Abstracts 8508 and LBA8512).
For a heavily pretreated multiple myeloma population, daratumumab as a monotherapy showed meaningful, durable activity with deep responses and a favorable safety profile. Saad Usmani, MD, of the Levine Cancer Institute, provides the highlights of this study on the first monoclonal antibody to show promise in multiple myeloma (Abstract LBA8512).
Triplets should be the standard of care in most newly diagnosed multiple myeloma patients, according to a study that validated a practice that has become common in the United States, though not necessarily elsewhere. The use of three drugs led to significant reductions in disease progression and...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 30, 2015, elotuzumab (Empliciti) was approved for...
Few malignancies have received as much attention, in the way of newly approved drugs, as multiple myeloma did in 2015. In November alone, 3 new agents were approved, bringing the total to 4 for the year as part of a record 7 approvals and to 16 regulatory approvals over the past 12 years. Speakers...
Amgen announced on January 21 that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application of carfilzomib (Kyprolis) for injection in combination with dexamethasone or with lenalidomide (Revlimid) plus dexamethasone for the treatment of patients with relapsed or...
Subcutaneous administration of bortezomib (Velcade) was comparably efficacious to intravenous administration in a phase III trial in patients with relapsed multiple myeloma, but the SC route “seemed to have an improved systemic safety profile compared with intravenous delivery,’’ investigators...
Three randomized controlled trials presented at the 2010 Annual Meeting of the American Society of Hematology (ASH) suggested that treating multiple myeloma with lenalidomide (Revlimid) increased the risk of second primary malignancies; of particular concern is transformation to acute myeloid...
Myeloma data reported at this year’s ASCO meeting raise concern about the safety of a mainstay class of drugs in this disease, while also hinting at good efficacy of some novel drugs and approaches, according to William I. Bensinger, MD, of the Fred Hutchinson Cancer Research Center, Seattle....
The National Comprehensive Cancer Network (NCCN) 6th Annual Congress on Hematologic Malignancies, held recently in New York, included reviews of the management of hematologic diseases as well as discussions of outstanding issues in the field. The following is a synopsis of some of the important...
Data on pomalidomide, the novel oral immunomodulatory drug for multiple myeloma, was a major highlight of the 2011 ASH Annual Meeting, according to Kenneth D. Anderson, MD, of Dana-Farber Cancer Institute, Boston, who called the drug “very, very exciting.” Paul Richardson, MD, also of Dana-Farber...
Myeloma experts agree that the new proteosome inhibitors are particularly welcome because they are at least as effective as bortezomib (Velcade) but produce much less neuropathy. Dramatic Results “The activity of MLN 9708 is very encouraging,” said Paul G. Richardson, MD, of Dana-Farber Cancer...
The next-generation proteasome inhibitor carfilzomib is expected to gain FDA approval in the near future, offering a treatment option that may be as effective as and less neurotoxic than bortezomib (Velcade). Studies presented at the ASH Annual Meeting upheld benefits of the drug observed in...
With a wealth of new agents of various classes in the pipeline, “myeloma is going to become a chronic illness, with sustained complete responses achieved in a significant fraction of patients,” according to Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute and Harvard Medical School, ...
Elotuzumab, a humanized IgG1 monoclonal antibody targeting human CS1, a cell-surface glycoprotein expressed on 95% of myeloma cells, elicited responses in 82% of relapsed/refractory myeloma patients in a phase II study reported at the ASH Annual Meeting.1 Objective response rates exceeded 90% in...
Carfilzomib is an oral second-generation proteasome inhibitor with a mechanism of action that may increase efficacy and reduce adverse effects currently associated with proteasome inhibitor therapy. It is being investigated for use in multiple myeloma and select solid tumors, and the FDA has...
Five-year analysis of the VISTA trial confirms a survival advantage with VMP (bortezomib [Velcade], melphalan, and prednisone) for upfront treatment of multiple myeloma in patients who were not transplant candidates. At a median follow-up of 60.1 months, a 13-month improvement in overall survival...
The benefit of maintenance therapy in newly diagnosed multiple myeloma patients ineligible for stem cell transplant, such as the elderly, is still debated, though value appears to be emerging, according to studies presented at the 2011 American Society of Hematology (ASH) Annual Meeting....
For over 30 years, Kenneth C. Anderson, MD, Kraft Family Professor of Medicine at Harvard Medical School and Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at Dana-Farber Cancer Institute in Boston, has focused his translational research on B-cell ...
The FDA recently released a safety announcement about an increased risk of second primary malignancies in patients with newly diagnosed multiple myeloma who received treatment with lenalidomide (Revlimid). Clinical trials conducted after lenalidomide was approved showed that newly diagnosed...
In 1996, at just 37, the last thing Kathy Giusti expected to hear was that she had the fatal blood cancer multiple myeloma. An executive at Searle Pharmaceuticals and the mother of an 18-month-old daughter, Giusti was told she probably had 3 years to live. At the time, treatments for the disease...
Three phase III, double-blind, multicenter, randomized studies showed that lenalidomide (Revlimid) maintenance therapy for patients with multiple myeloma significantly improved progression-free survival or time to progression, the primary endpoints of the studies published in The New England...
Advances in next-generation DNA sequencing technologies are allowing scientists to decipher the whole genome or whole exome (ie, the coding region of the genome) of cancer specimens more quickly and inexpensively than ever before. And the results are revealing genes that had not previously been...
Onyx Pharmaceuticals recently announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11–0 (with 1 abstention) that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome...
Onyx Pharmaceuticals announced that the FDA has granted accelerated approval to carfilzomib (Kyprolis) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib (Velcade) and an immunomodulatory therapy, and have...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In July 2012, carfilzomib (Kyprolis) was granted...
Metronomic chemotherapy using a multidrug regimen appears beneficial and fairly well tolerated in patients with multiple myeloma that is highly refractory to previous treatments, investigators from the Myeloma Institute for Research and Therapy in Little Rock, Arkansas, reported.1 Their results...
Carfilzomib (Kyprolis), the next-generation proteasome inhibitor recently approved by the FDA for relapsed/refractory multiple myeloma, showed strong activity in the front-line setting when paired with lenalidomide (Revlimid) and low-dose dexamethasone (CRd).1 The study evaluated stringent complete ...
Developing early-phase clinical trials that incorporate combinations of novel agents targeting different pathways in the hematologic cancer multiple myeloma is a leading focus of the work of Sagar Lonial, MD, Professor of Hematology and Vice Chair of Clinical Affairs in the Department of Hematology ...
A final analysis of the phase III VISTA trial (Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment with Melphalan and Prednisone) found a persistent significant benefit in overall survival with VMP (bortezomib, melphalan, prednisone) vs MP (melphalan, prednisone) in patients with...
An investigational oral proteasome inhibitor currently known as MLN9708 could make the treatment of multiple myeloma much more convenient and possibly less neurotoxic, according to the results of a phase I/II study of treatment-naive multiple myeloma patients presented at the 54th Annual Meeting of ...
Support for the oral immunomodulatory agent pomalidomide for multiple myeloma took a step forward when the phase III MM-003 trial showed a survival advantage in patients with advanced disease, in addition to a doubling in progression-free survival, when pomalidomide was given with low-dose...
An overall survival benefit in newly diagnosed multiple myeloma was attained with a four-drug induction regimen followed by a duet for maintenance in a study from the Italian GIMEMA network. Antonio Palumbo, MD, Chief of the Myeloma Unit at the University of Torino in Italy, reported the findings...
The 54th Annual Meeting of the American Society of Hematology (ASH) featured about 5,000 abstracts, including oral sessions and posters, as well as named lectures and symposia. In addition to our regular news coverage from the meeting, below are capsule summaries of a few news highlights that we...
At the 54th Annual Meeting of the American Society of Hematology (ASH), held in Atlanta, nearly 5,000 abstracts were presented in oral sessions and posters. As part of our ongoing comprehensive coverage from the meeting, here are several more studies of note. New Targets in Acute Myeloid Leukemia...
The FDA approved pomalidomide (Pomalyst) an oral immunomodulatory agent, to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is intended for patients who have received at least two prior therapies, including lenalidomide...
A survey of Veterans Affairs (VA) medical centers recently reported by Nancy L. Keating, MD, MPH, and colleagues at Harvard Medical School in the Journal of the National Cancer Institute showed that the presence of multidisciplinary tumor boards had little association with rates of recommended...
A large Swedish study using population-based data to estimate the risk of bacterial and viral infections among 9,610 patients with multiple myeloma (9,253 eligible for analysis) found that the myeloma patients had a 7-fold risk of developing any infection compared to 34,931 matched controls from...
Maintenance therapy with thalidomide (Thalomid) and prednisone after autologous stem cell transplantation in patients with multiple myeloma improved progression-free survival but not overall survival, according to results of a phase III trial reported in Blood. Patients receiving maintenance...
Multiple myeloma subtypes are driven by a variety of genetic abnormalities. Given the genetic diversity of the disease, identification of oncogenic mechanisms common to all subtypes is highly desirable. In a study reported in Cancer Cell, Lamy and colleagues found that that all multiple myeloma...
FDA has granted daratumumab breakthrough therapy designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and...
The International Myeloma Working Group (IMWG) has developed clinical practice recommendations for the management of multiple myeloma-related bone disease based on published study data through August 2012. Consensus of the interdisciplinary panel of clinical experts on the plasma-cell cancer was...
Among the more than 200 types of cancer are those called “forgotten” or “orphan” cancers, with fewer than 40,000 new cases each year. They present treatment challenges in community cancer centers. Because of the low incidence of these diseases, such as chronic myeloid leukemia, acute promyelocytic...
Attendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following...
The International Myeloma Working Group (IMWG) has developed clinical practice recommendations for the management of multiple myeloma-related bone disease based on published study data through August 2012. Consensus of the interdisciplinary panel of clinical experts on the plasma cell cancer was...
Julie M. Vose, MD, MBA, is the Neumann M. and Mildred E. Harris Professor and Chief of the Division of Hematology/Oncology at the University of Nebraska Medical Center. She grew up in Mitchell, South Dakota, a small town nestled on the banks of the James River. Mitchell is home to the Corn Palace,...