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In the phase III CASSIOPEIA trial, reported in The Lancet and presented at the 24th Annual Congress of the European Hematology Association (EHA; Abstract S145) by Moreau et al, daratumumab plus bortezomib/thalidomide/dexamethasone (D-VTd) given before and after autologous stem cell transplantation...
In the phase III MAIA trial reported in The New England Journal of Medicine, Facon et al found that the addition of daratumumab to lenalidomide/dexamethasone significantly improved progression-free survival in previously untreated multiple myeloma ineligible for autologous stem cell transplantation ...
In a study reported in the Journal of Clinical Oncology, Perrot et al identified a cytogenetic prognostic index predictive of survival in patients with newly diagnosed multiple myeloma. Study Details The study involved data from 1,635 patients in four trials conducted by the Intergroupe...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
Sagar Lonial, MD, of Winship Cancer Institute of Emory University, discusses the potentially practice-changing phase III findings showing that lenalidomide substantially delayed progression of smoldering multiple myeloma to aggressive disease when compared with observation alone (Abstract 8001).
Michael A. Thompson, MD, PhD, of Advocate Aurora Health, discusses the implications of the revised diagnostic criteria for multiple myeloma, which removed patients at the highest risk of disease progression from the smoldering group, and a new model for smoldering disease that incorporates revised cutoffs for the previously used parameters (Abstract 8000).
Francesca Gay, MD, of GIMEMA, European Myeloma Network, discusses the results of the FORTE trial on the efficacy of carfilzomib/lenalidomide/dexamethasone with or without autologous stem cell transplantation according to risk status in newly diagnosed disease (Abstract 8002).
Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses findings from the phase III ICARIA-MM trial showing that isatuximab, pomalidomide, and low-dose dexamethasone significantly improved progression-free survival and overall response vs pomalidomide and dexamethasone (Abstract 8004).
Kamal Chamoun, MD, of University Hospitals Seidman Cancer Center, discusses how better insurance coverage determines not only the ability of patients with multiple myeloma to afford high-priced oral medications, but their survival of the disease (Abstract LBA107).
A new study analyzing demographic statistics from the National Cancer Database presented by Chamoun et al at the 2019 ASCO Annual Meeting (Abstract LBA107) identified multiple socioeconomic factors—including private insurance, living in a regionally higher-income area, and receiving treatment ...
In the phase III OPTIMISMM trial, reported by Richardson et al in The Lancet Oncology, researchers found that the addition of pomalidomide to bortezomib/dexamethasone improved progression-free survival in relapsed or refractory multiple myeloma previously treated with lenalidomide. Study Details...
This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...
A phase III randomized trial (E3A06) by Lonial et al testing the effect of single-agent lenalidomide vs observation in patients with intermediate- or high-risk smoldering multiple myeloma has found that lenalidomide significantly reduces the risk of smoldering multiple myeloma progressing to active ...
In a phase I trial reported in The New England Journal of Medicine, Raje et al found that bb2121, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), was safe in heavily pretreated patients with relapsed or refractory multiple myeloma. Investigators reported ...
A certain type of DNA marker may predict poor outcomes in multiple myeloma, researchers at Winship Cancer Institute of Emory University have found. The marker is a particular rearrangement of chromosomes that is rarely tested for but may indicate resistance to immunomodulatory drugs such as...
IN SPITE of the high response rates and lack of progression to active disease with the regimens described at the 2018 American Society of Hematology Meeting & Exposition, several myeloma experts interviewed by The ASCO Post said the data do not yet move them to routinely intervene in high-risk...
In this installment of Living a Full Life, guest editor Jame Abraham, MD, FACP, interviewed multiple myeloma pioneer Robert A. Kyle, MD, whose groundbreaking work has changed the practice of hematology. Among his many honors are the David A. Karnofsky Memorial Award from ASCO and the Wallace H....
In an analysis of the phase III UK Myeloma X trial reported in the Journal of Clinical Oncology, Ahmedzai et al found that patient-reported outcomes tended to be worse with salvage autologous stem cell transplantation (ASCT) vs nontransplantation consolidation in relapsed multiple myeloma. The...
On March 21, 2019, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma. The statement alerts health-care professionals and patients about the suspension of the BELLINI trial (ClinicalTrials.gov identifier NCT02755597) of ...
This week, the U.S. Food and Drug Administration (FDA) granted designations for treatments for recurrent glioblastoma, neurofibromatosis type 1 and plexiform neurofibromas, multiple myeloma, and relapsed or refractory FLT3-ITD acute myeloid leukemia (AML). Fast Track Designation for Ad-RTS-hIL-12...
KENNETH SHAIN, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, told The ASCO Post that ixazomib is “an effective drug,” but he is not ready to use it as maintenance therapy. He noted that the TOURMALINE-MM3 trial did meet its primary endpoint—but not...
IN PATIENTS with newly diagnosed multiple myeloma who responded well to induction therapy and underwent transplant, 2 years of maintenance therapy with ixazomib led to a 38% improvement in progression-free survival compared with placebo, according to the results of the phase III TOURMALINE-MM3...
THE ASCO POST asked Ajay K. Nooka, MD, MPH, Associate Professor, Division of Bone Marrow Transplant at Winship Cancer Institute, Emory University, to comment on studies involving daratumumab. “After the phase III SWOG S0777 trial demonstrated a survival benefit with a 3-drug induction regimen...
DARATUMUMAB APPEARS to be the “gift that keeps on giving” to the myeloma community. “It seems we can add daratumumab to almost anything and make the regimen better. It’s got good activity and a good safety profile,” said Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt...
This week, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma, and also posted a warning letter against a company for illegally marketing unapproved products labeled as homeopathic. Safety Statement The FDA posted...
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
THE TREATMENT approaches for multiple myeloma, both newly diagnosed and relapsed disease, continue to undergo major transformation as new agents and combinations are being introduced.1 This change has been driven by the introduction of novel drug classes such as monoclonal antibodies, as well as...
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 II ELOQUENT-3 trial has shown that the addition of elotuzumab to pomalidomide and dexamethasone significantly prolonged...
ON FEBRUARY 12 , 2019, the U.S. Food and Drug Administration (FDA) approved a split-dosing regimen for daratumumab (Darzalex), providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. Daratumumab is a CD38-directed...
TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab to lenalidomide and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract presentation by Thierry...
The first symptom of my multiple myeloma appeared 6 months before I received the official diagnosis. I began having some discomfort, not pain exactly, in my right hip, and developed a pronounced limp. I had recently left my medical practice to launch Global Girls Global Women, a nonprofit...
The U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for daratumumab (Darzalex), a CD38-directed antibody, providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. The approval is based on...
The burgeoning pipeline of chimeric antigen receptor (CAR) T-cell therapies targeting B-cell maturation antigen (BCMA) in multiple myeloma was on full display at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. A bispecific antibody also made its debut in this busy...
In a phase III trial reported in the Journal of Clinical Oncology, Stadtmauer and colleagues found that second autologous hematopoietic cell transplantation (AHCT) or RVD (lenalidomide, bortezomib, dexamethasone) consolidation as post-AHCT interventions did not improve outcomes vs single...
Here is an update on several different studies focusing on novel treatments for patients with relapsed or refractory multiple myeloma presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. The featured therapeutics include the oral agent selinexor in...
Here is an update on several different studies focusing on novel treatments for patients with newly diagnosed multiple myeloma presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. Featured therapeutics include daratumumab plus lenalidomide and dexamethasone, ...
In a UK phase III trial (Myeloma XI) reported in The Lancet Oncology, Jackson et al found that lenalidomide maintenance was associated with improved progression-free survival but not overall survival among patients with newly diagnosed multiple myeloma with at least minimal response to induction...
Thirteen years ago, at age 34, I was healthy and enjoying life. I went to the gym almost daily, and when I wasn’t at the gym, I was shooting hoops with my friends. During a gym workout while on a family vacation, I suddenly felt excruciating pain in my left shoulder and thought I must have strained ...
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Interim results from a large international phase III clinical trial show that adding the immunotherapy daratumumab (Darzalex) to standard therapy significantly extended progression-free survival (PFS) in newly diagnosed patients with multiple myeloma who were ineligible for a stem cell transplant....
Paul Richardson, MD, of Dana-Farber Cancer Institute, discusses updated results and the first report on progression-free survival for melflufen therapy administered to people with multiple myeloma that is refractory to daratumumab and/or pomalidomide (Abstract 600).
Francesca M. Gay, MD, of GIMEMA, European Myeloma Network, discusses study findings on the use of carfilzomib in induction combination regimens with autologous transplantation, and consolidation regimens in newly diagnosed multiple myeloma (Abstract 121).
As reported in The New England Journal of Medicine by Dimopoulos et al, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and dexamethasone significantly prolonged progression-free survival in patients with relapsed and/or refractory...
ON NOVEMBER 6, 2018, following Priority Review, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at...
On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies,...
The U.S. Food and Drug Administration (FDA) has accepted a new drug application seeking accelerated approval for selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with pentarefractory multiple myeloma. The FDA...
Advances in the treatment of multiple myeloma have led to longer progression-free survival, but the majority of patients will still relapse despite newer treatments. A number of new drugs and combinations are under study in the hope of improving outcomes. “Multiple myeloma is a complex disease...
The U.S. Food and Drug Administration (FDA) recently permitted marketing of the ClonoSEQ assay, a next-generation sequencing–based test for minimal residual disease in patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma. “At the FDA, we’re continuing to...