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As reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, Alexandra Hospital, and colleagues in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis)...
TOPLINE RESULTS of the phase III ARROW trial (ClinicalTrials.gov identifier NCT02412878) were recently announced by Amgen. The study showed carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed patients with relapsed or refractory multiple myeloma to live 3.6 months ...
In a European phase II trial reported in the Journal of Clinical Oncology, Dimopoulos et al found that pomalidomide (Pomalyst) plus low-dose dexamethasone produced responses in patients with relapsed or refractory multiple myeloma and renal impairment. Study Details In the study, 81 patients with ...
In a phase II trial reported in the Journal of Clinical Oncology, Vogl et al found that the investigational oral selective exportin 1 (XPO1) inhibitor selinexor combined with dexamethasone produced responses in patients with heavily pretreated relapsed or refractory multiple myeloma. ...
KEN SHAIN, MD, Assistant Member of the Department of Malignant Hematology and Tumor Biology, Moffitt Cancer Center in Tampa, Florida, and Scientific Director of the Moffitt Myeloma Working Group, moderated the session where the study was presented and offered comments to The ASCO Post. “Professor...
IN PATIENTS undergoing treatment of multiple myeloma, the prophylactic use of levofloxacin significantly reduced febrile episodes and deaths, without increasing healthcare-associated infections or carriage of key nosocomial pathogens, in a large multicenter study from the United Kingdom.1 The...
On June 16, 2017, daratumumab -(Darzalex) was approved for use in combination with pomalidomide (Pomalyst) and dexamethasone for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.1,2 Supporting...
The final overall survival results of the phase III ASPIRE trial indicate significant improvement with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) vs lenalidomide plus dexamethasone (Rd) in patients who had received one to three prior lines of therapy for multiple...
As reported in the Journal of Clinical Oncology by Kenneth Anderson, MD, of Dana-Farber Cancer Institute, and colleagues, ASCO has issued a clinical practice guideline update on the role of bone-modifying agents in multiple myeloma. The update was informed by an expert panel systematic literature...
In a systematic review and meta-analysis reported in JAMA Oncology, Waxman et al found that any-grade and grade ≥ 3 cardiovascular adverse events occurred in 18.1% and 8.2% of patients receiving carfilzomib (Kyprolis) for multiple myeloma in clinical trials. Study Details The study involved...
On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...
Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for denosumab (Xgeva) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients...
The proteasome inhibitor carfilzomib (Kyprolis) has taken on an increasing role in the treatment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the therapy may come with the risk of cardiovascular problems in a higher than expected...
COMMENTING ON the ALCYONE trial for The ASCO Post, Keith Stewart, MB, ChB, the Carlson and Nelson Endowed Director of the Center for Individualized Medicine at the Mayo Clinic, Rochester, Minnesota, said, “Daratumumab added to a combination of drugs that we don’t use much anymore in the United...
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...