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...
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...
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...
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...
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...
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...
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 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...
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...
On February 22, the U.S. Food and Drug Administration (FDA) expanded the existing indication for lenalidomide (Revlimid) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant. The expanded indication makes...
Trial results presented by Stadtmauer during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-1) suggest two therapies that are often added to standard therapy in patients with multiple myeloma do not improve rates of progression-free survival ...
On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior...
New research shows that excess weight increases the risk that a benign blood disorder will progress to multiple myeloma. The study, by a team at Washington University School of Medicine in St. Louis, is published in the Journal of the National Cancer Institute. Being overweight or obese has been...
Katja Weisel, MD, of the University of Tübingen, discusses in German study findings on daratumumab, bortezomib, and dexamethasone vs bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. (Abstract 906O)
Katja Weisel, MD, of the University of Tübingen, discusses study findings on daratumumab, bortezomib, and dexamethasone vs bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. (Abstract 906O)
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the immunotherapy daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have ...
S. Vincent Rajkumar, MD, of the Mayo Clinic, and Sagar Lonial, MD, of the Emory University School of Medicine, discuss key issues in treating this disease, including monoclonal antibodies, plasmacytoma, and plasma cell leukemia.
Sagar Lonial, MD, of Emory University School of Medicine, and Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, discuss the top presentations on multiple myeloma delivered at this year’s meeting.
Antonio Palumbo, MD, of the University of Torino, discusses this phase III study of daratumumab, bortezomib, and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (Abstract LBA4).
Antonio Palumbo, MD, of the University of Torino, discusses in Italian this phase III study of daratumumab, bortezomib, and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (Abstract LBA4). To see the English language version of this...
Initial findings from a pivotal phase III trial showed that daratumumab (Darzalex) added to a standard two-drug regimen (bortezomib [Velcade] and dexamethasone) markedly improved outcomes for patients with recurrent or refractory multiple myeloma. The daratumumab combination reduced the risk of...
Michele Cavo, MD, of the Seràgnoli Institute of Hematology, Bologna University School of Medicine, discusses in Italian results from this phase III study of upfront autologous stem cell transplantation vs novel agent-based therapy for multiple myeloma (Abstract 8000). To see the English language ...
Michele Cavo, MD, of the Seràgnoli Institute of Hematology, Bologna University School of Medicine, discusses results from this phase III study of upfront autologous stem cell transplantation vs novel agent-based therapy for multiple myeloma (Abstract 8000). To see the Italian version of this...
Several clinical trials have demonstrated that maintenance therapy with lenalidomide (Revlimid) after autologous hematopoietic stem cell transplant reduces the risk of disease progression in patients with multiple myeloma, but there have been no definitive results regarding overall...
Early findings from a phase III clinical trial (EMN02/HO95 MM) showed that patients with multiple myeloma who received an autologous stem cell transplant survived longer without disease progression than those who received only chemotherapy using novel agents. This is the largest study reported to...
A gene known as TJP1 (tight junction protein 1) could help determine which multiple myeloma patients would best benefit from proteasome inhibitors such as bortezomib, as well as combination approaches to enhance proteasome inhibitor sensitivity, according to a study led by researchers from The...
Kenneth Anderson, MD, of Dana-Farber Cancer Institute, discusses how the many advances in the treatment of multiple myeloma affect current and future clinical practice.
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,”...
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...
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...
A first-in-human phase I study of multiple myeloma patients combined expanded cord blood-derived natural killer cells with transplantation of a patient’s own stem cells and high-dose chemotherapy, with little or none of the side effects seen with current treatments. Results from the clinical...
In a study update presented by Plesner et al at the 57th American Society of Hematology (ASH) Annual Meeting, daratumumab (Darzalex) was shown to be safe and effective in combination with lenalidomide (Revlimid) and dexamethasone in patients with relapsed/refractory multiple myeloma (Abstract 507). ...
In a study presented by Moureau et al at the 57th American Society of Hematology (ASH) Annual Meeting, ixazomib (Ninlaro), a recently approved oral proteasome inhibitor, significantly extended progression-free survival for patients with relapsed and/or refractory multiple myeloma (Abstract 727)....
A study (Abstract LBA1) to be reported by Abbas Ali et al at the 57th American Society of Hematology (ASH) Annual Meeting demonstrated promising early outcomes of a first-in-human trial using a patient’s own genetically modified immune cells to eradicate multiple myeloma. The study...
The U.S. Food and Drug Administration (FDA) granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts...
The U.S. Food and Drug Administration (FDA) granted approval for ixazomib (Ninlaro) in combination with two other agents to treat patients with multiple myeloma who have received at least one prior therapy. “As we learn more about the underlying biology of multiple myeloma, we are encouraged ...
Today the U.S. Food and Drug Administration granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome ...
The U.S. Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application for the investigational oral proteasome inhibitor ixazomib for the treatment of patients with relapsed or refractory multiple myeloma, Takeda Pharmaceuticals announced. The New Drug...
Bristol-Myers Squibb and AbbVie today 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...
As part of a multi-institutional effort, researchers with Huntsman Cancer Institute at the University of Utah have found that patients with multiple myeloma with a genetic variation in the gene FOPNL die, on average, 1 to 3 years sooner than patients without it. The finding was identified with...
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. The approval was based on a demonstration of ...
Results from a clinical trial investigating a new T-cell receptor therapy demonstrated a clinical response in 80% of patients with multiple myeloma who had advanced disease after undergoing autologous stem cell transplants. Researchers at Penn’s Abramson Cancer Center modified T cells to ...
Spending more leisure time sitting was associated with a higher risk of total cancer risk in women, specifically heightened multiple myeloma, breast, and ovarian cancer risk, according to a new study by the American Cancer Society. The higher risk was present even after taking into account body...
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible U.S. patients. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The multicenter, open-label...
A large, cooperative group study directed by the Alliance for Clinical Trials in Oncology has confirmed previous evidence that the drug lenalidomide (Revlimid) delays time to disease progression for patients with multiple myeloma and is an important treatment option for patients with this rare but...
“Daratumumab monotherapy produced unprecedented overall responses that deepened over time” in a phase II trial among patients with heavily treated multiple myeloma, study author Saad Zafar Usmani, MD, reported at a press conference at the 2015 ASCO Annual Meeting. Dr. Usmani, a...