Melphalan Flufenamide Withdrawn From the U.S. Market
On October 22, Oncopeptides announced its decision to withdraw melphalan flufenamide (Pepaxto), a first-in-class peptide-drug conjugate, from the market in the United States, following results from the phase III OCEAN study in patients with relapsed or refractory multiple myeloma. The decision to...
Overall Survival in the MAIA Trial: Daratumumab, Lenalidomide, and Dexamethasone for Newly Diagnosed Transplant-Ineligible Patients With Multiple Myeloma
As reported in The Lancet Oncology by Thierry Facon, MD, and colleagues, an interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to lenalidomide/dexamethasone in newly diagnosed, transplant-ineligible patients with ...
Triplet Therapy and Lenalidomide Maintenance to Prevent Disease Progression in High-Risk Smoldering Myeloma
In a single-center phase II trial reported in JAMA Oncology, Kazandjian et al found that triplet therapy with carfilzomib, lenalidomide, and dexamethasone (KRd), followed by lenalidomide maintenance, produced high rates of measurable residual disease (MRD)-negative complete response and freedom...
CASSIOPEIA Part 2: Maintenance Daratumumab After Initial Therapy for Newly Diagnosed Multiple Myeloma
As reported in The Lancet Oncology by Philippe Moreau, MD, and colleagues, an interim analysis of part 2 of the phase III CASSIOPEIA trial has shown significantly prolonged progression-free survival with maintenance daratumumab vs observation following induction and consolidation with or without...
Saad Z. Usmani, MBA, MD, on Multiple Myeloma: Updated Results From the CARTITUDE-1 Study of Ciltacabtagene Autoleucel
Saad Z. Usmani, MBA, MD, of the Levine Cancer Institute, discusses new data on the CAR T-cell therapy ciltacabtagene autoleucel, a single infusion of which yielded early, deep, and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma (Oral Abstract MM-119).
Consolidation Treatment With VRD Followed by Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma
In a phase III European Myeloma Network trial (EMN02/HOVON95) reported in the Journal of Clinical Oncology, Sonneveld et al found that consolidation with bortezomib, lenalidomide, and dexamethasone (VRD) vs no consolidation followed by maintenance lenalidomide was associated with significantly...
Bispecific Antibodies Advance in Relapsed or Refractory Multiple Myeloma
For the challenging population of patients with multiple myeloma who have become refractory to essentially all current treatments, new approaches are much needed. Early clinical trials data suggest bispecific antibodies may help meet this need, as suggested by studies presented at the 2021 ASCO...
Treatment of Relapsed Myeloma: Options Include New Drugs, Novel Combinations
The treatment paradigm for multiple myeloma continues to evolve at a rapid pace with the introduction of new drugs and the development of drug combinations, particularly the initial approach to the treatment of newly diagnosed multiple myeloma.1 One major shift in the treatment of newly diagnosed...
Subcutaneous Daratumumab Added to Pomalidomide Plus Dexamethasone Improves Progression-Free Survival in Multiple Myeloma
As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous (SC) daratumumab to oral...
Daratumumab and Hyaluronidase-fihj With Pomalidomide Plus Dexamethasone in Multiple Myeloma
On July 9, 2021, daratumumab and hyaluronidase-fihj was approved for use in combination with pomalidomide and dexamethasone (Pd) for treatment of adults with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.1 Supporting...
Addition of Venetoclax to Daratumumab/Dexamethasone With or Without Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
In a phase I study reported in the Journal of Clinical Oncology, Bahlis et al found that venetoclax plus daratumumab/dexamethasone (VenDd) and VenDd with bortezomib (VenDVd) produced high rates of durable responses in patients with relapsed or refractory multiple myeloma with t(11;14) translocation ...
Muhamed Baljevic, MD, on Multiple Myeloma: Review of Novel Management Strategies
Muhamed Baljevic, MD, of the University of Nebraska Medical Center, reviews the outlook for treating patients with relapsed and refractory multiple myeloma, the rapidly expanding array of therapeutic options with novel mechanisms of action, and the challenges of sequencing treatments.
Muhamed Baljevic, MD, on Multiple Myeloma: Review of Novel Management Strategies
Muhamed Baljevic, MD, of the University of Nebraska Medical Center, reviews the outlook for treating patients with relapsed and refractory multiple myeloma, the rapidly expanding array of therapeutic options with novel mechanisms of action, and the challenges of sequencing treatments.
Isatuximab-irfc in Relapsed or Refractory Multiple Myeloma
On March 31, 2021, the anti-CD38 monoclonal antibody isatuximab-irfc was approved for use in combination with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.1 Supporting Efficacy Data...
Nina Shah, MD, on Newly Diagnosed Multiple Myeloma: Novel Combination Therapies
Nina Shah, MD, of the University of California, San Francisco, discusses triplet drug combinations that are the current standard of care for transplant-eligible and -ineligible patients with multiple myeloma, as well as quadruplet therapies that demonstrate depth of response in newly diagnosed cases, where they may become the standard of care along with transplantation and maintenance treatments.
Teclistamab Shows Efficacy, Produces Durable Responses in Relapsed or Refractory Multiple Myeloma
In a phase I trial (MajesTEC-1) reported in The Lancet, Saad Z. Usmani, MD, FACP, and colleagues found that the B-cell maturation antigen (BCMA)-CD3 bispecific antibody teclistamab produced a high rate of durable responses at the recommended phase II dose in patients with relapsed or refractory...
S. Vincent Rajkumar, MD, on Multiple Myeloma: Defining Cure
S. Vincent Rajkumar, MD, of the Mayo Clinic, talks about how, in light of the fact that multiple myeloma has been turned into a chronic disease for many people, what it means to “cure” patients; the difference between curable and cured in multiple myeloma; and key studies he is involved in that could help determine whether using the best possible treatments early in the course of the disease can lead to cures.
Surbhi Sidana, MD, Comments on CAR T-Cell Therapy and Bispecific Antibodies Targeting Myeloma
The session’s invited discussant Surbhi Sidana, MD, Assistant Professor of Medicine, Stanford University, said CAR T-cell therapy and bispecific antibodies targeting myeloma are emerging as potentially effective options for patients with highly refractory disease. For this population of triple...
Bispecific Antibodies Advance in Relapsed or Refractory Multiple Myeloma
For the challenging population of patients with multiple myeloma who have become refractory to essentially all current treatments, new approaches are much needed. Early clinical trials data suggest bispecific antibodies may help meet this need, as suggested by studies presented at the 2021 ASCO...
FDA Alert: Clinical Trial Results Show an Increased Risk of Death Associated With Melphalan Flufenamide
The U.S. Food and Drug Administration (FDA) is alerting patients and health-care professionals that a clinical trial (OCEAN, Study OP-103; ClinicalTrials.gov identifier: NCT03151811) evaluating melphalan flufenamide with dexamethasone to treat patients with multiple myeloma showed an increased risk ...
Paul G. Richardson, MD, on Multiple Myeloma and COVID-19: An Update
Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses challenges patients with multiple myeloma have faced as a result of the COVID-19 pandemic and the research he and his international colleagues are conducting to better understand these difficulties and improve patient care.
FDA Approves Daratumumab and Hyaluronidase-fihj With Pomalidomide and Dexamethasone for Pretreated Patients With Multiple Myeloma
On July 9, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a...
Defining Cure in Multiple Myeloma
The past 2 decades have seen so many advances in the treatment of multiple myeloma; in addition, median patient survival has grown from just 3 years in the late 1990s to between 8 and 10 years today,1 with some patients exceeding that prognosis by many years. Although still considered a stubbornly...
Study Finds Response to COVID-19 Vaccination Varies Widely in Patients With Multiple Myeloma
Patients with multiple myeloma had a wide variety of responses to COVID-19 vaccines—in some cases, no detectable response at all—pointing to the need for antibody testing and precautions for these patients after vaccination, according to a study published by Van Oekelen et al in Cancer Cell. Mount...
BCMA-Directed CAR T-Cell Therapy Ciltacabtagene Autoleucel in Relapsed or Refractory Multiple Myeloma
In the phase Ib/II CARTITUDE-1 trial reported in The Lancet, Jesus G. Berdeja, MD, and colleagues found that ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell therapy with two B-cell maturation antigen (BCMA)-targeting single-domain antibodies, produced a high rate of...
Newly Diagnosed Multiple Myeloma
“Continuous improvement is better than delayed perfection.” —Mark Twain To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on...
Cristina Gasparetto, MD, on Multiple Myeloma: Selinexor, Carfilzomib, and Dexamethasone in Carfilzomib-Nonrefractory Patients
Cristina Gasparetto, MD, of Duke University, discusses findings from a study that suggests patients with heavily pretreated multiple myeloma benefit from weekly selinexor, carfilzomib, and dexamethasone, which was reported to be active, with an overall response rate of 78% and an overall progression-free survival of 23 months (Abstract S188).
Philippe Moreau, MD, on Newly Diagnosed Multiple Myeloma: Daratumumab Maintenance vs Observation
Philippe Moreau, MD, of University Hospital Hôtel-Dieu, discusses findings from the CASSIOPEIA trial, Part 1, on daratumumab maintenance vs observation in patients with newly diagnosed multiple myeloma who have been treated with bortezomib, thalidomide, and dexamethasone, with or without daratumumab, and autologous stem cell transplantation (Abstract S180).
Martin Kaiser, MD, on Myeloma and Plasma Cell Leukemia: Transplantation Plus Daratumumab/CVRD Therapy
Martin Kaiser, MD, of The Institute of Cancer Research and Royal Marsden Hospital, discusses findings from the UK OPTIMUM/MUKNINE trial on the depth of response and minimal residual disease status in patients with ultra-high–risk newly diagnosed multiple myeloma and plasma cell leukemia who were treated with augmented autologous transplant and daratumumab plus cyclophosphamide, bortezomib, lenalidomide, and dexamethasone (Abstract S181).
FDA Pipeline: Priority Reviews in Multiple Myeloma, Cervical Cancer, Neutropenia, and Myelofibrosis
Over the past month, the U.S. Food and Drug Administration (FDA) has granted Priority Review to therapies for multiple myeloma, cervical cancer, chemotherapy-induced neutropenia, and myelofibrosis. The FDA also granted a number of Breakthrough Therapy designations, including those for treatments in ...
Overall Survival With the Addition of Ixazomib to Lenalidomide/Dexamethasone in Relapsed or Refractory Multiple Myeloma
As reported in the Journal of Clinical Oncology by Paul G. Richardson, MD, and colleagues, the final overall survival analysis of the phase III TOURMALINE-MM1 trial showed no overall survival benefit with the addition of ixazomib to lenalidomide/dexamethasone (Rd) in relapsed or refractory multiple ...
Addition of Isatuximab-irfc to Carfilzomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma: IKEMA Trial
As reported in The Lancet by Philippe Moreau, MD, and colleagues, the phase III IKEMA trial has shown that the addition of the anti-CD38 antibody isatuximab-irfc to carfilzomib and dexamethasone resulted in significantly improved progression-free survival in patients with relapsed or refractory...
Overall Survival Benefit With Upfront Daratumumab Plus Lenalidomide/Dexamethasone for Newly Diagnosed Transplant-Ineligible Patients With Multiple Myeloma
In an updated analysis of the phase III MAIA trial, the addition of daratumumab to lenalidomide and dexamethasone resulted in a statistically significant overall survival benefit over lenalidomide/dexamethasone alone in patients with newly diagnosed multiple myeloma who are ineligible for...
APOLLO Trial: Addition of Subcutaneous Daratumumab to Pomalidomide/Dexamethasone in Previously Treated Patients With Multiple Myeloma
As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous daratumumab to pomalidomide/dexamethasone in patients with previously treated multiple myeloma....
Taiga Nishihori, MD, on Multiple Myeloma: Maintenance Ixazomib After Transplant
Taiga Nishihori, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses the outcome of a trial that explored maintenance therapy with ixazomib after allogeneic hematopoietic cell transplantation in patients with high-risk multiple myeloma. Toxicities unrelated to the maintenance treatment forced the trial to close prematurely (Abstract 7003).
Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma
On March 26, 2021, idecabtagene vicleucel was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1,2 Idecabtagene vicleucel is...
Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 26, 2021, the peptide-conjugated alkylating...
Frail Patients With Newly Diagnosed Multiple Myeloma: Triplet Regimen
In the phase II Hovon 143 trial reported in the Journal of Clinical Oncology, Stege et al found that a regimen of ixazomib, daratumumab, and low-dose dexamethasone (Ixa-Dara-dex) was associated with a high response rate in frail patients with newly diagnosed multiple myeloma, but also a high rate...
Daratumumab in Combination With Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma
Results from the single-institution phase II MANHATTAN study were reported in JAMA Oncology recently by Ola Landgren, MD, PhD, and colleagues. The investigators found that daratumumab in combination with weekly carfilzomib, lenalidomide, and dexamethasone resulted in high rates of minimal residual...
Anti-BCMA–Directed CAR T-Cell Gene Therapy in Relapsed or Refractory Myeloma
"The noblest pleasure is the joy of understanding.” —Leonardo da Vinci To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel...
Recent Studies Explore Efficacy of COVID-19 Vaccination in Patients With Leukemia and Myeloma
Two new studies published in the journal Blood suggest that the BNT162b2 mRNA COVID-19 vaccine may have reduced efficacy in individuals with chronic lymphocytic leukemia (CLL) and multiple myeloma. According to researchers, these studies could help inform the ideal time for vaccination of these...
Role of Whole-Genome Sequencing in Identifying Patients With MGUS at Risk of Progression to Multiple Myeloma
A study published by Oben et al in Nature Communications has shown that whole-genome sequencing can help determine which patients with a multiple myeloma precursor condition known as monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma may be at risk for progression to...
FDA Approves Isatuximab-irfc Combination for Relapsed or Refractory Multiple Myeloma
On March 31, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. IKEMA The efficacy...
FDA Approves Idecabtagene Vicleucel for Heavily Pretreated Patients With Multiple Myeloma
On March 26, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 ...
Shaji K. Kumar, MD, on Multiple Myeloma: NCCN Guidelines Update
Shaji K. Kumar, MD, of the Mayo Clinic Cancer Center, discusses the latest data on treating patients with multiple myeloma, including standard-of-care induction before stem cell transplant; the role of quadruplet induction; long-term results with the combination of daratumumab, lenalidomide, and dexamethasone in those who are ineligible for stem cell transplant; CAR T-cell engagers; and the need for more research on how immunotherapy fits in the sequence of treatments.
Older Patients With Multiple Myeloma May Be Able to Avoid Long-Term Steroid Use
The combination of lenalidomide plus the steroid dexamethasone (together called Rd) is considered standard treatment for elderly patients with multiple myeloma. However, prolonged steroid use can be harmful for some older adults. A new study published by Larocca et al in the journal Blood found...
Belantamab Mafodotin-blmf Plus Pomalidomide and Dexamethasone Elicits Responses in Myeloma
Belantamab mafodotin-blmf combined with pomalidomide and dexamethasone led to a very good partial response or better in approximately three-quarters of patients with multiple myeloma that was double-class or triple-class refractory, according to Suzanne Trudel, MSc, MD, FRCPC, of Princess Margaret...
Once-Weekly Selinexor Plus Bortezomib/Dexamethasone vs Twice-Weekly Bortezomib/Dexamethasone in Multiple Myeloma
As reported in The Lancet by Sebastian Grosicki, MD, of the Medical University of Silesia, Katowice, Poland, and colleagues, the phase III BOSTON trial has shown significantly prolonged progression-free survival with once-weekly selinexor plus bortezomib/dexamethasone vs twice-weekly...
Idecabtagene Vicleucel for Heavily Pretreated Patients With Relapsed or Refractory Multiple Myeloma
In the pivotal phase II KarMMa study reported in The New England Journal of Medicine, Nikhil C. Munshi, MD, and colleagues found that the B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel produced high response rates in patients with...
