© 2024 HSP News Service, L.L.C.
FOR NEWLY DIAGNOSED multiple myeloma patients not eligible for transplant, the addition of the anti-CD38 monoclonal antibody daratumumab (Darzalex) to subcutaneous bortezomib (Velcade), melphalan, and prednisone (VMP) reduced the risk of disease progression or death by 50%, the phase III ALCYONE...
The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, discusses phase III study findings on daratumumab plus bortezomib, melphalan, and prednisone vs bortezomib, melphalan, and prednisone in patients ineligible for transplant who have been newly diagnosed with multiple myeloma (Abstract LBA-4).
A one-time infusion of an investigational chimeric antigen receptor (CAR) T-cell therapy that targets a protein found on most multiple myeloma cells elicited an 86% overall response rate in 21 patients whose disease had come back or had not responded after a median of seven prior treatments,...
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
With the recent U.S. Food and Drug Administration (FDA) approvals of two chimeric antigen receptor (CAR) T-cell products, this novel approach seems to be moving into the mainstream. The approvals were tisagenlecleucel (also known as CTL019; Kymriah) for the treatment of pediatric B-cell acute...
Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...
In a phase II study reported in Blood Advances, Green et al found that tandem autologous/allogeneic hematopoietic cell transplantation (HCT) followed by bortezomib (Velcade) maintenance produced good results in patients with newly diagnosed high-risk multiple myeloma. Poorer outcomes were observed...
THE NATIONAL CANCER INSTITUTE (NCI) Molecular Analysis for Therapy Choice (MATCH) clinical trial has achieved the goal of screening nearly 6,000 patients in just under 2 years, according to data presented at the 2017 American Association for Cancer Research–NCI–European Organisation for Research...
The treatment paradigm for multiple myeloma has changed dramatically in the past decade with the availability of several efficacious agents in various drug classes. At the National Comprehensive Cancer Network® (NCCN®) 13th Annual Congress: Hematologic Malignancies™, Shaji K. Kumar, MD, Professor...
LOCATION! LOCATION! LOCATION! That’s what home buyers are frequently cautioned about before purchasing a property. For trialists, and more importantly, practicing oncologists, a study’s design, akin to a property’s location, must be taken into account prior to buying into the results and changing ...
On October 23, topline results of the phase III ARROW trial were announced, showing carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than...
WITH THE INCLUSION of proteasome inhibitors and immunomodulatory agents first into salvage and then as components of first-line, consolidation, and maintenance regimens, response rates, depth of response, and median progression-free and overall survival have all improved for patients suffering...
AT A PRESPECIFIED interim analysis, the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, as reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian...
The National Comprehensive Cancer Network® (NCCN®) has instituted Categories of Preference for recommendations within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Initially, Categories of Preference will be published for drugs and biologics recommended within...
Despite a flurry of treatment advances in multiple myeloma over the past decade that have increased overall survival from just 2 to 3 years in the 1990s to between 5 and 7 years today—with some data suggesting an extended life expectancy of between 7 and 10 years1—the cancer remains stubbornly...
Staying up-to-date in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology. The topics range from therapy for stage IV non–small cell lung cancer...
Researchers are tackling multiple myeloma from many angles, and the result could be a flood of novel approaches soon within the oncologist’s reach, according to Kenneth C. Anderson, MD. At the 2017 Debates and Didactics in Hematology and Oncology Conference at Sea Island, Georgia, Dr. Anderson...
As reported by Dimopoulos et al in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma. Carfilzomib was...
On August 31, U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research Director Janet Woodcock, MD, issued the following statement: “Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening...
On August 24, positive topline results were announced from the phase III ALCYONE study of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) vs VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for...
THE ADDITION of daratumumab (Darzalex) to a triplet induction regimen led to good responses in newly diagnosed multiple myeloma, but not without toxicities. And in the treatment of myeloma bone disease, denosumab (Xgeva) in place of zoledronic acid preserved renal function and may be associated...
According to a meta-analysis reported in the Journal of Clinical Oncology by McCarthy et al, lenalidomide (Revlimid) maintenance therapy after autologous stem cell transplantation (ASCT) was associated with improved progression-free and overall survival vs placebo or observation in patients with...
THE 22ND CONGRESS of the European Hematology Association (EHA) was held in June in Madrid, drawing hematologists and allied professionals from every subspecialty of hematology from around the world. Among the extensive educational and scientific program, the EHA Congress provides a forum for...
A study reported by Moreau et al in the Journal of Clinical Oncology indicated no difference between magnetic resonance imaging (MRI) and positron-emission tomography–computed tomography (PET-CT) in detecting bone lesions at diagnosis in patients with multiple myeloma. PET-CT normalization...
Although I was officially diagnosed with multiple myeloma in 1997, the first sign of the cancer was evident 2 years earlier, when a single lesion (a plasmacytoma) was found in a bone in my lower back. The bone was replaced with two thin stainless steel rods, and after a course of radiation therapy, ...
On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...
"We are now seeing the merger of immunotherapy with precision medicine. This is the epitome of personalized medicine,” said ASCO-invited expert Michael S. Sabel, MD, Chief of the Division of Surgical Oncology at University of Michigan Health Systems, Ann Arbor. He called the effort to target...
Chinese investigators reported that 100% of patients with relapsed or refractory multiple myeloma responded to autologous chimeric antigen receptor (CAR) T-cell therapy, and 14 of 19 (74%) who were followed for a median of 4 months achieved a stringent complete response and have not recurred.1...
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab -(Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide ...
Data from two phase I/II clinical trials evaluating ixazomib (Ninlaro) in patients with newly diagnosed multiple myeloma was presented at the 2017 European Hematology Association (EHA) Annual Meeting (Abstracts S408, S780). Both studies evaluated ixazomib plus lenalidomide (Revlimid) and...
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide...
According to a study by Olszewski and colleagues in the Journal of Clinical Oncology, Medicare Part D beneficiaries without a low-income subsidy may face daunting barriers in affording oral immunomodulatory drugs for myeloma. The low-income subsidy markedly reduces out-of-pocket costs for...
The U.S. Food and Drug Administration (FDA) has approved the use of daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a...
Over the past 20 years, the Intergroupe Francophone du Myelome (IFM) and Dr. Michel Attal have pioneered the use of autologous hematopoietic cell transplantation (AHCT) for multiple myeloma in a series of randomized studies. Notable studies include comparisons of planned upfront AHCT vs...
In the French phase III IFM 2009 trial reported in The New England Journal of Medicine by Michel Attal, MD, of the Institut Universitaire du Cancer de Toulouse-Oncopole, and colleagues, consolidation treatment with lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVD) was...
Here are several abstracts selected from the proceedings of the 2016 America Society of Hematology (ASH) Annual Meeting & Exposition, highlighting newer therapeutics for the development for patients with relapsed or refractory multiple myeloma. For full details of these study abstracts, visit...
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drug, more than 100 sites, new partnerships, and a revised protocol to lower the age of eligibility. “We are very pleased with the...
In an early clinical trial, 33 out of 35 (94%) patients had clinical remission of multiple myeloma upon receiving immunotherapy with chimeric antigen receptor (CAR) T cells targeting B-cell maturation protein, or BCMA. Most patients had only mild side effects. The study was presented by Fan et al...
A pooled analysis of three PETHEMA/GEM studies has shown that minimum residual disease (MRD)-negative status after induction therapy is more prognostic of favorable outcome than complete response alone in newly diagnosed multiple myeloma. The findings were reported by Lahuerta et al in the Journal...
Here are several abstracts selected from the proceedings of the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting newer therapeutics in smoldering and relapsed and/or refractory multiple myeloma. For the full details of these study abstracts, visit...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2017 Guidelines In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology®, covering 8 tumor types. Guidelines are now published for more than 60 tumor types and...
On February 22, lenalidomide (Revlimid) was approved as maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplantation.1,2 The drug was previously approved to treat multiple myeloma (in combination with dexamethasone), anemia caused by...
Minimal residual disease is a promising biomarker for guiding the management of multiple myeloma that is becoming increasingly important with the advent of more efficacious therapies, according to emerging data and expert opinion. “The story of minimal residual disease in multiple myeloma is like...
From immunomodulatory agents and proteasome inhibitors to steroids, alkylators, and antibodies, recent years have witnessed an explosion of drug approvals for multiple myeloma. The challenge now, said Amrita Krishnan, MD, FACP, is figuring out how to incorporate them all, particularly in the...
In a population-based cohort study reported in the Journal of the National Cancer Institute, Su-Hsin Chang, PhD, of the Washington University School of Medicine, and colleagues found that overweight and obesity were associated with an increased risk of transformation of monoclonal gammopathy of...
The advent of successful monoclonal antibody therapy in the treatment of relapsed/refractory myeloma has dramatically improved the prognosis of patients for whom currently approved novel therapies have failed. In 2015, the approval of the combination of elotuzumab (Empliciti) with lenalidomide...
As reported in The New England Journal of Medicine by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III POLLUX trial has shown that the addition of the CD38-targeted antibody daratumumab (Darzalex) to lenalidomide...
Amrita Krishnan, MD, Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research at the City of Hope in Duarte, California, told The ASCO Post that the most exciting drug in the “New Agents” session she moderated at the 2016 American Society of Hematology (ASH) Annual Meeting...