Patient-Reported Outcomes With Salvage Autologous Stem Cell Transplantation vs Nontransplantation in Relapsed Multiple Myeloma
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...
FDA Warning: Investigational Use of Venetoclax in Multiple Myeloma
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 ...
FDA Pipeline: Designations in Glioblastoma, Neurofibromatosis, Multiple Myeloma, and AML
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...
Expert Point of View: Kenneth Shain, MD, PhD
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...
Maintenance Ixazomib Delays Disease Progression in Newly Diagnosed Myeloma
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...
Expert Point of View: Ajay K. Nooka, MD, MPH
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...
ASH Reports Show Benefit of Adding Daratumumab to Initial Therapy in Multiple Myeloma
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...
FDA Pipeline: Safety Warning About Investigational Use of Venetoclax in Multiple Myeloma, Warning Letter on Unapproved Products
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...
FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More
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...
Reshaping the Treatment Landscape in Refractory Multiple Myeloma
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...
Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Patients With Multiple Myeloma
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...
FDA Approves Split-Dosing Regimen of Therapy for Multiple Myeloma
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...
Highlights From the 2018 ASH Annual Meeting & Exposition
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...
Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma: Outcomes From the MAIA Trial
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...
Cancer Has Given Me the Life I Was Meant to Live
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...
FDA Approves Daratumumab Split-Dosing Regimen
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...
Multiple Myeloma Pipeline Filled With CAR T-Cell Therapies
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...
Trial of Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma
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...
Novel Therapeutics for Relapsed or Refractory Multiple Myeloma, Part 2
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...
Novel Treatments in Newly Diagnosed Multiple Myeloma, Part 1
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, ...
Lenalidomide Maintenance vs Observation in Newly Diagnosed Multiple Myeloma
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...
I Welcome Being the Face of Multiple Myeloma
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 ...
Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma
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...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
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...
ASH 2018: MAIA Trial: Does Adding Daratumumab Improve Outcomes in Patients With Newly Diagnosed Multiple Myeloma Ineligible for Stem Cell Transplant?
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, on Multiple Myeloma: Results From the OP-106 Horizon Trial
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, on Multiple Myeloma: Results From the Forte Trial
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).
ELOQUENT-3: Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Multiple Myeloma
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...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
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...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
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,...
FDA Accepts New Drug Application, Grants Priority Review to Selinexor for Pentarefractory Multiple Myeloma
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...
Emerging Options and Sequencing Therapy in Relapsed Multiple Myeloma
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...
FDA Authorizes First Next-Generation Sequencing–Based Test to Detect Minimal Residual Disease in B-Cell ALL or Multiple Myeloma
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...
FDA Approves Once-Weekly Carfilzomib in Combination With Dexamethasone for Relapsed or Refractory Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) to expand the prescribing information for carfilzomib (Kyprolis) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or...
Shaji K. Kumar, MD, on Multiple Myeloma: Treatment Update
Shaji K. Kumar, MD, of the Mayo Clinic Cancer Center, discusses emerging therapeutic options for relapsed multiple myeloma and how best to sequence treatments.
Natalie S. Callander, MD, on Newly Diagnosed Multiple Myeloma: Expert Perspective
Natalie S. Callander, MD, of the University of Wisconsin Carbone Cancer Center, discusses key patient and clinical factors that influence first-line treatment choices, as well as the efficacy and tolerability of multiple myeloma therapies.
FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who...
New Tool for Assessing Frailty Predicts Survival in Newly Diagnosed Multiple Myeloma
A new frailty index predicts overall survival for patients newly diagnosed with multiple myeloma, according to a study recently published in JCO Clinical Cancer Informatics (JCO CCI). This tool is important because frailty is a critical factor in treatment decision-making for many patients with...
Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma
In May 2018, daratumumab (Darzalex) was approved for use in combination with VMP (bortezomib, melphalan, and prednisone) in the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1 Supporting Efficacy Data Approval was based on...
Drug Combination Design for Multiple Myeloma Using an AI Platform
A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...
New Tool for Assessing Frailty in Patients With Newly Diagnosed Multiple Myeloma
A NEW “frailty index” may predict overall survival for patients newly diagnosed with multiple myeloma, according to a study published in JCO Clinical Cancer Informatics.1 Frailty is a critical factor in treatment decision-making for many patients with multiple myeloma, as many of these patients are ...
New Frontiers Being Explored in Multiple Myeloma
BEFORE TOO LONG, oncologists can expect to have an entirely new arsenal in the fight against multiple myeloma. Cutting-edge therapies on the near horizon were described in a presentation by Kenneth Anderson, MD, at the 2018 American Association of Cancer Research’s (AACR’s) inaugural conference on...
FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells, which prevents them from being...
New Tool for Assessing Frailty May Aid in Predicting Survival in Newly Diagnosed Multiple Myeloma
A new frailty index may aid in predicting overall survival for patients newly diagnosed with multiple myeloma, according to a study published by Mian et al in JCO Clinical Cancer Informatics. This tool is important because frailty is a critical factor in treatment decision-making for ...
FDA Grants Fast Track Designation to Galinpepimut-S in Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to galinpepimut-S for the treatment of multiple myeloma. Galinpepimut-S is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor types....
Phase 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...
Expert Point of View: Parameswaran Hari, MD
FORMAL DISCUSSANT Parameswaran Hari, MD, of the Medical College of Wisconsin, Milwaukee, was impressed by many aspects of the bb2121 study, which represents the “largest and most mature” data set for the chimeric antigen receptor (CAR) T-cell approach in myeloma, he noted. According to Dr. Hari,...
CAR T-Cell Therapy: Updated Data Remain Favorable in Heavily Pretreated Patients With Myeloma
IN AN UPDATE of a phase I trial, a heavily pretreated population of patients with multiple myeloma continued to respond to the chimeric antigen receptor (CAR) T-cell therapy bb2121.1 The results presented at the 2018 ASCO Annual Meeting confirmed previous findings for bb2121 in the dose-escalation...
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...
