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In 2011, the Multiple Myeloma Research Foundation (MMRF) announced the launch of CoMMpass (Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile), a clinical study at the heart of its Personalized Medicine Initiative. CoMMpass will follow 1,000 newly diagnosed...
The term “novel agents” has been used for the past decade to describe proteasome inhibitors and immunomodulatory drugs that are now conventionally used for multiple myeloma. However, even newer agents in development will be considered truly novel when they hit the market, as they represent new...
In 2012, three randomized placebo-controlled trials reported a significant prolongation of progression-free survival with lenalidomide (Revlimid) as maintenance therapy for multiple myeloma.1-3 Two of these trials tested lenalidomide maintenance after stem cell transplantation, and one investigated ...
At the 19th Annual Conference of the National Comprehensive Cancer Network (NCCN), held recently in Hollywood, Florida, NCCN Panel members presented updates for several tumor types, briefly summarized here. For a more complete description of all updates, visit www.nccn.org. Breast Cancer Guidelines ...
A multicenter, open-label phase II trial found that the selective proteasome inhibitor carfilzomib (Kyprolis), in combination with cyclophosphamide and dexamethasone produced high complete response rates and was associated with low toxicity in patients with newly diagnosed multiple myeloma....
At the 2014 ASCO Annual Meeting, one phase III trial confirmed the promise of a novel agent in advanced multiple myeloma, while another cooperative group trial returned some rather surprising results in newly diagnosed myeloma patients. Panobinostat Doubles Response, Prolongs Remission The phase...
Higher-dose carflizomib (Kyprolis) “provided a high overall response rate with a remarkable duration of response in patients with relapsed or refractory multiple myeloma” in a phase II study, Nikoletta Lendvai, MD, PhD, and colleagues from Memorial Sloan Kettering Center, New York, wrote in Blood....
Michael S. Katz, MBA, has lived longer than any of his doctors thought he would. A two-time cancer survivor, Mr. Katz was diagnosed, first with multiple myeloma in 1990 and then with colorectal cancer in 2008, and has spent the past 2 decades tirelessly advocating for patients with cancer. The...
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 August 8, 2014, the approved use of bortezomib (Velcade) in...
The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes...
The field of multiple myeloma is rapidly changing, and the shifts that are occurring impact the management of these patients, from initial diagnosis through multiple relapses. At the 9th Annual New Orleans Summer Cancer Meeting, Sergio A. Giralt, MD, Chief of the Adult Bone Marrow Transplant...
CS1 is a cell surface glycoprotein that appears to be highly expressed on myeloma cells and less expressed on normal cells; CS1 overexpression has been found to promote myeloma cell growth and survival by increasing myeloma adhesion to bone marrow stromal cells and increasing myeloma colony...
Melphalan in combination with bortezomib (Velcade) should be maintained as one of the standards of care for the treatment of elderly patients with multiple myeloma, concluded Spanish trialists reporting updated results from the GEM2005 study comparing bortezomib/melphalan/prednisone with...
With powerful new drugs capable of achieving sustained and deep remissions in multiple myeloma, the role of upfront stem cell transplantation is being questioned by experts, who debated the pros and cons at the National Comprehensive Cancer Network (NCCN) 9th Annual Congress on Hematologic...
Multiple Myeloma Research Foundation (MMRF) has announced an initiative designed to accelerate the evaluation of new investigational therapies for multiple myeloma. The MMRF, in collaboration with the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), pharmaceutical,...
In an important recent study by Dr. Antonio Palumbo and colleagues,1 reviewed in this issue of The ASCO Post (page 128), 273 patients aged ≤ 65 years were randomly assigned to early transplant or consolidation therapy using MPR (melphalan, prednisone, and lenalidomide [Revlimid]) after successful...
In a phase III trial reported in The New England Journal of Medicine, Antonio Palumbo, MD, Chief of the Myeloma Unit at the University of Turin, Italy, and colleagues found that high-dose melphalan plus autologous stem cell transplantation improved progression-free survival and overall survival...
The FIRST trial—reported by Benboubker and colleagues in The New England Journal of Medicine and summarized in this issue of The ASCO Post (page 93)—is a landmark study.1 It is one of the largest randomized trials in multiple myeloma ever conducted. More importantly, it is a well-designed trial...
In the phase III FIRST trial reported in The New England Journal of Medicine, Lotfi Benboubker, MD, Service d’Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France, and colleagues found that continuous lenalidomide (Revlimid) plus...
Carfilzomib (Kyprolis), as a single agent, failed to improve survival in relapsed and refractory myeloma patients, as compared with a corticosteroid and optional cyclophosphamide, in the phase III FOCUS trial, presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid.1...
The use of histone deacetylase (HDAC) inhibitors as human cancer therapy has focused on the impact of these agents on epigenetic regulation and gene transcription. However, the use of HDAC inhibitors in myeloma may be working through a different mechanism. Specifically, HDAC6 is known to regulate...
In the phase III PANORAMA 1 trial reported in The Lancet Oncology, Jesus F. San-Miguel, MD, of Clinica Universidad de Navarra-CIMA, Pamplona, Spain, and colleagues found that adding the pan-deacetylase inhibitor panobinostat to bortezomib (Velcade) and dexamethasone improved progression-free...
New therapies for multiple myeloma have dramatically improved life expectancy, but despite these advances, 5-year overall survival still remains below 50%. Investigators are in hot pursuit of new therapies that will extend remissions and improve survival. Thus far, monoclonal antibodies,...
For newly diagnosed multiple myeloma patients, Cleveland Clinic specialists believe two drugs may suffice for most patients, bucking the trend toward using triplets for all patients and reserving them for patients with insufficient response to two. They described a pilot study of their “carepath”...
The phase III global ASPIRE trial documented an “unprecedented” duration of remission in relapsed multiple myeloma patients receiving carfilzomib (Kyprolis) plus a standard-of-care doublet, according to Keith Stewart, MB, ChB, Professor of Medicine at the Mayo Clinic in Scottsdale, Arizona, who...
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least...
An investigational class of agents in multiple myeloma, the anti-CD38 monoclonal antibodies, could be the next blockbusters in this malignancy, myeloma experts predicted at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. Anti-CD38 antibodies target multiple myeloma...
Two orally administered proteasome inhibitors—oprozomib and ixazomib—looked encouraging in multiple myeloma studies presented at the 2014 ASH Annual Meeting and Exposition. Study Details for Oprozomib Oprozomib, given as a single agent in a dose-escalation study of heavily pretreated patients,...
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
The U.S. Food and Drug Administration (FDA) has approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is...
At the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, attendance at many multiple myeloma sessions outnumbered the room size, as data from studies of novel agents, such as the monoclonal antibodies, and from key trials, such as ASPIRE, drew crowds. The ASCO Post covered...
Joseph Mikhael, MD, MEd, myeloma expert at the Mayo Clinic in Arizona, Scottsdale, and Associate Dean of the Mayo School of Graduate Medical Education, considers five questions when selecting treatment for patients with multiple myeloma who relapse. “With prolonged survival, which approaches 10...
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 February 23, 2015, panobinostat (Farydak) was granted...
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 February 18, 2015, the indication for lenalidomide (Revlimid)...
Currently in myeloma, there are at least five new agents that are either approved or in the late-stage of development with impending approval. Major questions in the field relate to how we, as clinicians, will use these new agents and where they will fit in the overall treatment schema. The phase...
In a planned interim analysis of the phase III ASPIRE trial reported in The New England Journal of Medicine, A. Keith Stewart, MB, ChB, of the Mayo Clinic, Scottsdale, Arizona, and colleagues found that the addition of the proteasome inhibitor carfilzomib (Kyprolis) to lenalidomide...
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of ...
A frailty score predicts mortality and the risk of toxicity in elderly patients with multiple myeloma and can be used to determine more suitable therapies for these patients, the International Myeloma Working Group reported in Blood. “Chronologic age, performance status, and physician’s clinical...
For 2 decades, the NCCN Guidelines® have been recognized as the standard of cancer care in the United States, combining evidence, experience, and choice, so that multidisciplinary cancer treatment teams—including patients—are empowered to make informed decisions about cancer care,” said Robert W....
The monoclonal antibody elotuzumab, given with lenalidomide (Revlimid) and dexamethasone, extended progression-free survival by a median of 5 months, compared with lenalidomide/dexamethasone alone, in the eagerly awaited phase III ELOQUENT-2 trial, which will be presented at the 2015 ASCO Annual...
Heavily pretreated patients with multiple myeloma achieved rapid, durable, and deepening responses to the anti-CD38 monoclonal antibody daratumumab, in a phase II study presented at the 2015 ASCO Annual Meeting.1 “Daratumumab showed remarkable single-agent activity in heavily pretreated and...
In the first head-to-head study comparing two proteasome inhibitors in relapsed multiple myeloma, carfilzomib (Kyprolis)/dexamethasone provided a doubling in progression-free survival, compared with bortezomib (Velcade)/dexamethasone.1 Results of the phase III ENDEAVOR trial of the two regimens in...
We’ve seen how dramatically patients’ lives can change when they are matched with the right treatment at the right time in their disease course. Although this is still an exception and not the rule, we believe collaborative research approaches will make this kind of precision medicine a reality for ...
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible patients in the United States. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The...
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 July 24, 2015, carfilzomib (Kyprolis) was approved for use in...
The U.S. Food and Drug Administration (FDA) approved carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. In the United States, there are nearly...
The long wait for monoclonal antibodies for the treatment of multiple myeloma is over. In the landmark ELOQUENT-2 study, reviewed in this issue of The ASCO Post, Lonial and colleagues convincingly demonstrate the effectiveness of elotuzumab, a monoclonal antibody directed against SLAMF7, in the...
In an interim analysis of the phase III ELOQUENT-2 trial reported in The New England Journal of Medicine, Sagar Lonial, MD, of Emory University School of Medicine, Meletios Dimopoulos, MD, of National and Kapodistrian University of Athens, and colleagues found that the addition of elotuzumab to...
Bristol-Myers Squibb and AbbVie recently announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the...
I have always prided myself on being healthy and fit, so when I started experiencing a chronic cough, difficulty breathing, and pain in my ribs and back, I thought they were the inevitable symptoms of a severe cold. At 42 and the mother of three children, it was inconceivable to me that I could...