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Showing 101 - 150FDA Approves Daratumumab in Combination With VMP for Newly Diagnosed Patients With Multiple Myeloma Who Are Transplant-Ineligible
On May 7, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are...
MGUS and Multiple Myeloma in 9/11 Firefighters
A study by Landgren et al in JAMA Oncology has found that New York City firefighters exposed to the 9/11 World Trade Center (WTC) disaster site face an increased risk for developing monoclonal gammopathy of undetermined significance (MGUS), a myeloma precursor disease. The study was conducted...
Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma
On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. The FDA’s...
FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting
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...
FDA Approves Denosumab for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma
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...
Treatment With Carfilzomib May Lead to Cardiovascular Toxicity in Patients With Multiple Myeloma
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...
ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma
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...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
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, on Multiple Myeloma: Results From the ALCYONE Trial
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...
ASH 2017: Clinical Activity Seen With Anti-BCMA CAR T-Cell Therapy in Heavily Pretreated 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,...
Watch for More From ASH 2017
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...
Results From Phase III ARROW Study of Once-Weekly Carfilzomib in Relapsed/Refractory Multiple Myeloma
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...
NCCN Guidelines to Include Categories of Preference
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...
FDA Statement Regarding Safety Concerns Related to Investigational Use of Pembrolizumab in Multiple Myeloma
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...
Phase III ALCYONE Study of Daratumumab in Front-Line Treatment of Multiple Myeloma
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...
FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma
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...
EHA 2017: Ixazomib Plus Lenalidomide/Dexamethasone in Newly Diagnosed Multiple Myeloma With No Stem Cell Transplant, Followed by Maintenance Ixazomib
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...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
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 TAPUR Study Continues Its Expansion of Sites, Participants, and Collaborators
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...
ASCO 2017: BCMA-Specific CAR T-Cell Therapy Sends Relapsed/Refractory Multiple Myeloma Into Lasting Remission in an Early Trial
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...
FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
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...
ASH 2016: Additions to Standard Multiple Myeloma Therapy Do Not Appear to Yield Additional Benefit
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 ...
FDA Approves Daratumumab in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Multiple Myeloma
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...
Weight Loss May Help Prevent Multiple Myeloma
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, on Multiple Myeloma: Results of the CASTOR Study (German Language Version) 
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, on Multiple Myeloma: Results of the CASTOR Study
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)
FDA Grants Breakthrough Therapy Designation for Daratumumab in Combination With Standard of Care for Multiple Myeloma
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, and Sagar Lonial, MD, on Treating Multiple Myeloma
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, and Paul G. Richardson, MD, on Multiple Myeloma: Expert Perspectives on Treatment Advances
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, on Multiple Myeloma: Results From the CASTOR Trial
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, on Multiple Myeloma: Results From the CASTOR Trial (Italian Language Version) 
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...
ASCO 2016: Adding Daratumumab to Bortezomib and Dexamethasone Markedly Improves Outcomes in Recurrent/Refractory Multiple Myeloma
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, on Multiple Myeloma: Results From a European Myeloma Network Trial (Italian Language Version)
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, on Multiple Myeloma: Results From a European Myeloma Network Trial
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...
ASCO 2016: Maintenance Lenalidomide After Autologous Stem Cell Transplantation Improves Survival in Multiple Myeloma
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...
ASCO 2016: Autologous Stem Cell Transplant Remains Relevant in Multiple Myeloma, Even in Era of Novel Agents
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...
Tight Junction Protein 1 May Identify Sensitivity to Proteasome Inhibitors in Patients With Multiple Myeloma
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, on Multiple Myeloma Guideline Updates
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, on the Phase III ASPIRE Trial
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, on Monoclonal Antibodies in Multiple Myeloma
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...
FDA Approves Carfilzomib as Single Agent or in Combination in Relapsed/Refractory Multiple Myeloma
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...
ASH 2015: Multiple Myeloma Patient Study Shows Promise for Natural Killer Cells
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...
ASH 2015: Updated Results of the Phase I/II GEN503 Study of Daratumumab in Multiple Myeloma
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). ...
ASH 2015: Updated Results of Phase III Tourmaline-MM1 Study of Ixazomib in Multiple Myeloma
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)....
ASH 2015: First-in-Human Trial Using Engineered Cells to Target Multiple Myeloma Shows Early Promise
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...
FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
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...
FDA Approves Ixazomib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
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 ...
FDA Approves Daratumumab for Patients With Previously Treated Multiple Myeloma
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 ...
FDA Grants Priority Review to Ixazomib for Patients With Relapsed/Refractory Multiple Myeloma
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...
FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma
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...
