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Showing 101 - 150Phase III TOURMALINE-MM3 Trial of Ixazomib as Maintenance Therapy in Patients With Multiple Myeloma Posttransplant
The randomized, phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral ixazomib (Ninlaro) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) vs placebo. The trial evaluated the effect of ixazomib as a...
CAR T Cells Targeting B-Cell Maturation Antigen in Poor-Prognosis Relapsed Multiple Myeloma
In a first-in-human study reported in the Journal of Clinical Oncology, Brudno et al found that chimeric antigen receptor (CAR) autologous T cells targeting B-cell maturation antigen (BCMA) produced responses in patients with poor-prognosis relapsed multiple myeloma. Study Details The current...
Once- vs Twice-Weekly Carfilzomib in Relapsed or Refractory Multiple Myeloma
An interim analysis of the phase III ARROW trial reported in The Lancet Oncology by Moreau et al indicated that a higher-dose once-weekly schedule of carfilzomib was associated with prolonged progression-free survival vs a twice-weekly schedule in patients with relapsed or refractory multiple...
EHA 2018: Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone vs Pomalidomide/Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma
The ELOQUENT-3 trial, an international phase II study evaluating the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, achieved its primary endpoint, showing a statistically significant and clinically...
Studies of Daratumumab in Combination With Anti–PD-L1 Agents Stopped
On May 26, Genmab A/S announced that following a planned review, the Data Monitoring Committee (DMC) has recommended that the phase Ib/II study (CALLISTO/LUC2001) of daratumumab (Darzalex) in combination with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) vs ...
2018 ASCO: Pomalidomide, Bortezomib, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma
For patients with multiple myeloma who have been treated with lenalidome (Revlimid) but have relapsed and not responded to other therapy, a three-drug combination can significantly extend the time in which the disease is held in check. The findings of the phase III OPTIMISMM trial were presented by ...
Aviva C. Krauss, MD, on Multiple Myeloma: Treatment Trials Analysis
Aviva C. Krauss, MD, of the U.S. Food and Drug Administration, discusses findings on an FDA analysis of immune-related adverse events and response to pembrolizumab in multiple myeloma (Abstract 8008).
FDA Grants Orphan Drug Designation to Galinpepimut-S for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to galinpepimut-S for the treatment of multiple myeloma. The drug is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor...
FDA 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...
Analysis of Carfilzomib-Related Cardiotoxicity
In a systematic review and meta-analysis reported in Leukemia & Lymphoma, Shah et al identified the risk of cardiotoxicity among patients, most with multiple myeloma, receiving carfilzomib (Kyprolis) in clinical trials. Study Details The study included data from 4,164 patients who received...
Denosumab vs Zoledronic Acid in Newly Diagnosed Multiple Myeloma With Bone Disease
In a phase III trial reported in The Lancet Oncology, Raje et al found that denosumab was noninferior to zoledronic acid in preventing skeletal-related events (SREs) in newly diagnosed multiple myeloma patients with bone disease. Study Details In the double-blind trial, 1,718 patients with at...
Pomalidomide and Low-Dose Dexamethasone in Patients With Multiple Myeloma and Renal Impairment
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 ...
Selective Inhibition of Nuclear Export in Heavily Pretreated Relapsed or Refractory Multiple Myeloma
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. ...
ASPIRE Trial: Final Overall Survival Results in Relapsed or Refractory Multiple Myeloma
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...
Role of Bone-Modifying Agents in Multiple Myeloma: ASCO Clinical Practice Guideline Update
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...
Cardiovascular Adverse Events and Multiple Myeloma Treatment
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...
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...
Tandem Autologous/Allogeneic HCT With Maintenance Therapy in High-Risk Myeloma
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...
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...
Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma
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...
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...
Lenalidomide Maintenance After Autologous Stem Cell Transplantation in Multiple Myeloma
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...
Comparison of MRI vs PET-CT in Multiple Myeloma
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...
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...
Impact of Subsidies on Use of Oral Immunomodulatory Drugs in Medicare Beneficiaries With Myeloma
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...
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...
Spanish Analysis of Prognostic Impact of MRD-Negative Status in Multiple Myeloma
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...
Lenalidomide, Bortezomib, and Dexamethasone With or Without HCT in Younger Patients With Multiple Myeloma
A French phase III trial (IFM 2009), reported by Attal et al in The New England Journal of Medicine, has shown that consolidation treatment with lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVD) was associated with poorer progression-free survival vs high-dose chemotherapy and...
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...
Does Obesity Pose Risk for Transformation of Monoclonal Gammopathy of Undetermined Significance to Myeloma?
In a population-based cohort study reported in the Journal of the National Cancer Institute, Chang et al found that overweight and obesity were associated with an increased risk of transformation of monoclonal gammopathy of undetermined significance to multiple myeloma. Black race was also...
Does Adding Bortezomib to Lenalidomide/Dexamethasone Improve Outcomes in Patients With Newly Diagnosed Myeloma?
In the phase III SWOG S0777 trial reported in The Lancet, Durie et al found that adding bortezomib (Velcade) to lenalidomide (Revlimid)/dexamethasone improved progression-free and overall survival in patients with newly diagnosed myeloma who were not planned for immediate autologous stem cell...
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...
Lower Risk of All-Cause Mortality in Multiple Myeloma Reported With Treatment at Higher-Volume Facilities
In an analysis of data from the National Cancer Database reported in the Journal of Clinical Oncology, Go et al found a lower risk of all-cause mortality among patients with multiple myeloma treated at higher-volume facilities. Study Details The study included patients diagnosed with multiple...
Does Adding Daratumumab to Lenalidomide/Dexamethasone Improve Outcomes in Previously Treated Multiple Myeloma?
The addition of the CD38-targeted antibody daratumumab (Darzalex) to lenalidomide (Revlimid)/dexamethasone improved progression-free survival in patients with previously treated multiple myeloma, according to the results of the phase III POLLUX trial reported by Dimopoulos et al in The New England...
