Relapsed or Refractory Multiple Myeloma: Early-Phase Trial Investigates Novel Bispecific Antibody
In a phase I clinical trial, treatment with the investigational FcRH5×CD3 bispecific antibody cevostamab reduced cancer in more than 40% of patients with multiple myeloma—many of whom had already been through multiple other cancer treatments—and produced a median duration of response of 11.2 months ...
ASCO 2026: Multiple Myeloma Studies Highlight Advances Across the Field
The plasma cell dyscrasia oral abstract session at the 2026 ASCO Annual Meeting featured several pivotal trials that advanced the field, including those highlighted here. Coverage of new treatments for amyloidosis will appear in a separate article. Mezigdomide-Based Regimen Improves...
Defining Functional High-Risk Multiple Myeloma in the Era of Quadruplet Therapy and Autologous Stem Cell Transplant
Researchers have found that with new treatment regimens now available for functional high-risk multiple myeloma, clinicians should use different criteria for identifying patients with poor odds of survival. These findings were published by Ravi et al in the journal Cancer. Functional high-risk...
Tumor Microenvironment Ecotypes May Explain Differences in Multiple Myeloma Outcomes
Researchers have created a comprehensive single-cell map of the tumor immune microenvironment in multiple myeloma and its precursor conditions. The newly published findings provide insights that may explain why patients with similar diagnoses often have differences in disease progression, treatment ...
FDA Approves Isatuximab-irfc for Subcutaneous Injection for Multiple Myeloma Indications
On July 9, the U.S. Food and Drug Administration (FDA) approved the anti-CD38 monoclonal antibody isatuximab-irfc (Sarclisa Escena) for subcutaneous injection for multiple myeloma indications. The specific indications approved for isatuximab are: In combination with pomalidomide and dexamethasone...
Second Primary Malignancies After T-Cell–Engaging Bispecific Antibody Therapy
In a meta-analysis reported in JAMA Oncology, Tomasik et al found that second primary malignant neoplasms were a “clinically relevant complication” of treatment with T-cell–engaging bispecific antibodies (BsAbs) in patients with non-Hodgkin lymphoma or multiple myeloma. Study Details The analysis...
Talquetamab Combinations in Relapsed or Refractory Myeloma
In an interim analysis of a phase III trial (MonumenTAL-3) reported in The New England Journal of Medicine, Mina et al found that the combinations of talquetamab with daratumumab/pomalidomide (Tal-DP) and talquetamab plus daratumumab (Tal-D) improved progression-free survival vs...
Wearable Devices May Help Detect CRS Earlier in Patients With Myeloma Receiving CAR T-Cell Therapy
Researchers have found that wearable devices may help clinicians detect cytokine-release syndrome—a common and potentially serious side effect of chimeric antigen receptor (CAR) T-cell therapy—hours earlier than standard hospital monitoring in patients with multiple myeloma. The findings,...
Addition of Mezigdomide to Carfilzomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma
In an interim analysis of a phase III trial (SUCCESOR-2) reported in The Lancet, Dimopoulos et al found that the addition of the cereblon E3 ligase modulator mezigdomide to carfilzomib/dexamethasone significantly improved progression-free survival in previously treated patients with relapsed or...
Relapsed or Refractory Multiple Myeloma: Talquetamab/Daratumumab
Patients with multiple myeloma who received a new immunotherapy combination had significantly longer progression-free survival and showed early signs of improved overall survival, according to findings from the phase III MonumenTAL-3 trial. Peter M. Voorhees, MD, Professor of Medicine at Wake...
Off-the-Shelf CAR T-Cell Therapy Produces Deep, Durable Responses in Heavily Pretreated Multiple Myeloma
CB-011, the first allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell therapy incorporating immune cloaking, achieved a high overall response rate in heavily pretreated patients with relapsed or refractory multiple myeloma in the phase I CaMMouflage trial. Dose-escalation results were...
Preclinical Studies Evaluate Mezigdomide for T-Cell Dysfunction in Multiple Myeloma
In two complementary preclinical studies published in Blood, investigators reported that mezigdomide, a cereblon E3 ligase modulator, may help overcome T-cell dysfunction in multiple myeloma, thereby enhancing the activity of BCMA-directed CAR T-cell and bispecific T-cell engager therapies. These...
New Whole-Genome Sequencing Test Enables Genomically Informed Treatment Decision-Making in Multiple Myeloma
A clinical whole-genome sequencing test for patients with multiple myeloma, JAYseq, has been launched at the Translational Genomics Research Institute (TGen). “The launch of JAYseq represents a meaningful step in oncology testing, one that allows physicians to make a more precise treatment...
Targeted Therapies Drive Long-Term Decline in Multiple Myeloma Mortality in the United States
Investigators used data from the Surveillance, Epidemiology, and End Results (SEER) database to analyze trends in multiple myeloma mortality in the United States from 1975 to 2023. Their findings were published in Oncotarget. The study was led by first and corresponding author Navkirat Kahlon, MD,...
High-Risk Smoldering Multiple Myeloma: BCMA-Directed CAR T-Cell Therapy Shows Activity
A single infusion of the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel led to a 100% measurable residual disease (MRD)-negativity rate in patients with high-risk smoldering multiple myeloma, according to results from CAR-PRISM, a phase II clinical trial, presented at the...
Dynamic, Accessible Risk Stratification Tool Created for Smoldering Multiple Myeloma
Researchers have developed a dynamic risk stratification tool for patients with smoldering multiple myeloma to predict their chance of progression to active multiple myeloma. The tool, called Precursor Asymptomatic Neoplasms by Group Effort Analysis–Smoldering Multiple Myeloma (PANGEA-SMM),...
BCMA CAR T-Cell Therapy in Newly Diagnosed Multiple Myeloma
In a Chinese phase II study (CAREMM-001) reported in the Journal of Clinical Oncology, Yan et al found that B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy was highly active in patients with newly diagnosed multiple myeloma who were ineligible for or did not proceed...
FDA Approves Teclistamab and Daratumumab For Relapsed or Refractory Multiple Myeloma
On March 5, 2026, the U.S. Food and Drug Administration (FDA) approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a...
MajesTEC-3: ‘Unprecedented’ Benefit in Previously Treated Multiple Myeloma
For patients with previously treated multiple myeloma, the greatest risk reduction yet achieved in a phase III clinical trial was reported with the BCMA-directed CD3 T-cell engager teclistamab-cqyv plus daratumumab and hyaluronidase-fihj. Treatment with this combination resulted in an 83% reduction ...
ASH 2025: Highlights in Relapsed/Refractory Multiple Myeloma
“Dripping water hollows out stone, not through force but through persistence.” – Ovid The 2025 American Society of Hematology (ASH) Annual Meeting & Exposition delivered multiple practice-changing data sets surrounding T-cell–redirecting therapies in relapsed or refractory multiple myeloma....
Updated Analysis of CARTITUDE-4: Ciltacabtagene Autoleucel in Lenalidomide-Refractory Multiple Myeloma
As reported in The Lancet Oncology by Einsele et al, an updated analysis of the phase III CARTITUDE-4 trial has shown that a single infusion of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy, prolonged overall survival vs...
Multiple Myeloma: FDA Approves Daratumumab and Hyaluronidase-fihj in Combination With VRd
On January 27, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous...
Evolving Treatment Landscape Spurs Living Guideline Update on Multiple Myeloma
ASCO, in collaboration with Ontario Health (Cancer Care Ontario), has published an update to their previous guideline on the treatment of multiple myeloma.1 This new guideline—which has been selected as an ASCO Living Guideline—reflects dramatic changes that have helped improve the management of...
Dual Antigen Targeting of Drug-Resistant Extramedullary Myeloma
In a phase II trial (RedirecTT-1) reported in The New England Journal of Medicine, Kumar et al found that the combination of talquetamab (anti–G protein–coupled receptor family C group 5 member D) and teclistamab (anti–B-cell maturation antigen) produced high response rates in patients with...
FDA Releases Draft Guidance for Use of MRD and CR as Primary Endpoints in Multiple Myeloma Trials
On January 20, 2026, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry regarding the use of minimal residual disease and complete response as primary endpoints in clinical trials evaluating drugs and biologics for the treatment of patients with multiple myeloma that ...
Multiple Myeloma: Sex Differences in Etiology and Clinical Presentation
Rates of multiple myeloma, the second most common blood cancer in the United States, are increasing and are twice as high in men than in women. A new study published by Ong et al in the journal Cancer provides insights that may help to explain this disparity. To investigate the sex difference in...
MajesTEC-3: ‘Unprecedented’ Benefit in Previously Treated Multiple Myeloma
For patients with previously treated multiple myeloma, the greatest risk reduction yet achieved in a phase III clinical trial was reported with the BCMA-directed CD3 T-cell engager teclistamab-cqyv plus daratumumab and hyaluronidase-fihj. Treatment with this combination resulted in an 83% reduction ...
Researchers Create Immune Cell Atlas of Bone Marrow in Patients With Multiple Myeloma
Scientists at several institutions across the country, in partnership with the Multiple Myeloma Research Foundation (MMRF), have helped generate the largest single-cell immune cell atlas of the bone marrow in patients with multiple myeloma. The findings, published by Pilcher et al in Nature Cancer, ...
Using AI to Ensure That All Patients With Cancer Have Access to Precision Oncology Care
Steve Brown, Founder and Chief Executive Officer of CureWise (curewise.com), an artificial intelligence (AI)-driven patient advocacy app, describes his year-long quest to understand a series of symptoms that ultimately led to a diagnosis of light chain (AL) amyloidosis—a disease closely related to ...
Molecular Analysis Reveals Underlying Sex-Linked Multiple Myeloma Progression Patterns
Researchers have uncovered that sex-specific dysregulation of exosomal non-coding RNAs may drive different patterns of disease progression of multiple myeloma in male and female individuals, according to findings published in Blood Cancer Journal. “The same therapies are provided for men and women ...
Andrew Portuguese, MD, on Multiple Myeloma: Real-World Outcomes With Elranatamab
Andrew Portuguese, MD, of Fred Hutchinson Cancer Center, discusses findings from a multicenter analysis from the U.S. Multiple Myeloma Immunotherapy Consortium looking at the real-world safety and efficacy of the BCMA-CD3 bispecific antibody elranatamab (Abstract 136).
Experimental CAR T-Cell Therapy Shows High Efficacy and a Favorable Safety Profile in Multiple Myeloma
Updated findings from the phase II iMMagine-1 study show that anitocabtagene autoleucel (anito-cel), an investigational CAR T-cell therapy for relapsed or refractory multiple myeloma, continues to deliver high response rates with a reassuring safety profile. Researchers from The University of Texas ...
Alexander Lesokhin, MD: Can Patients With Relapsed/Refractory Multiple Myeloma Successfully Pause or Discontinue Elranatamab?
Alexander Lesokhin, MD, of Memorial Sloan Kettering Cancer Center, discusses results of a retrospective analysis from the phase II MagnetisMM-3 trial. A post hoc analysis was conducted of the subgroup of patients enrolled in the study who had a prolonged treatment interruption or who permanently discontinued elranatamab and maintained their responses for 6 months or longer (Abstract 2269).
Karthik Ramasamy, MBBS, FRCP, FRCPath, PhD, on Ultra–High-Risk Multiple Myeloma: RADAR Trial in Newly Diagnosed Transplant-Eligible Patients
Karthik Ramasamy, MBBS, FRCP, FRCPath, PhD, of the University of Oxford, discusses initial results of the phase II/III UK-based RADAR trial. The study evaluated isatuximab, bortezomib, lenalidomide, dexamethasone, and cyclophosphamide induction, followed by single autologous stem cell transplant, consolidation with isatuximab plus bortezomib, lenalidomide, and dexamethasone, and isatuximab plus lenalidomide maintenance, in patients with double-hit multiple myeloma (Abstract 98).
Shahzad Raza, MD, on Relapsed/Refractory Multiple Myeloma: Novel Doublet in Patients With Extramedullary Disease
Shahzad Raza, MD, of Cleveland Clinic, presents updated phase II results of the RedirecTT-1 trial, focusing on the efficacy and safety of talquetamab combined with teclistamab in patients with relapsed/refractory multiple myeloma and extramedullary disease (Abstract 698). The study also received simultaneous publication in The New England Journal of Medicine.
Dory Abelman, PhD(c), HBHSc, on Newly Diagnosed Multiple Myeloma: Ultradeep Whole-Genome Sequencing of cfDNA
Dory Abelman, PhD(c), HBHSc, of the University of Toronto, discusses findings that support the feasibility of ultradeep cell-free DNA whole-genome sequencing for comprehensive genomic profiling in patients with multiple myeloma, which may be a less invasive alternative to bone marrow biopsy (Abstract 495).
Benjamin Diamond, MD, on a Novel Quadruplet for Relapsed/Refractory Multiple Myeloma
Benjamin Diamond, MD, of the University of Miami, describes findings from the single-center phase II REKINDLE trial, which looked at the combination regimen of iberdomide, carfilzomib, daratumumab, and dexamethasone in patients with early relapsed/refractory multiple myeloma (Abstract 251).
Krina Patel, MD, MSc, on Anitocabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma
Krina Patel, MD, MSc, of The University of Texas MD Anderson Cancer Center, provides updated results from the fully enrolled, ongoing iMMagine-1 phase II registrational trial of anitocabtagene autoleucel, an autologous anti-BCMA CAR T-cell therapy with a novel D-domain binder. The agent is under development for patients with relapsed and/or refractory multiple myeloma (Abstract 256).
Jack Khouri, MD, on Multiple Myeloma: Burixafor and Propranolol With G-CSF Before Transplant
Jack Khouri, MD, of Cleveland Clinic, describes the findings of a phase II trial which investigated the safety and efficacy of burixafor (GPC-100), a potent and selective small -molecule antagonist of CXCR4, and propranolol with granulocyte colony-stimulating factor (G-CSF) for the mobilization of hematopoietic progenitor cells (HPC) in patients with multiple myeloma. Researchers aimed to boost the bone marrow HPC niche and optimize mobilization in patients with multiple myeloma eligible for autologous hematopoietic cell transplant (Abstract 1050).
Patient Immune System Characteristics and Long-Term Remission From CAR T-Cell Therapy in Multiple Myeloma
Patients with relapsed or refractory multiple myeloma who achieve a long-lasting disease remission from chimeric antigen receptor (CAR) T-cell therapy may differ from patients who relapse sooner based upon their immune system and how it responds to the infused CAR T cells, as well as how it...
FDA Approves Daratumumab and Hyaluronidase-fihj for High-Risk Smoldering Multiple Myeloma
On November 6, 2025, the U.S. Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma. Efficacy of daratumumab and hyaluronidase as monotherapy vs active monitoring was evaluated in AQUILA, an open-label,...
FDA Approves Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma
On October 23, 2025, the U.S. Food and Drug Administration (FDA) approved belantamab mafodotin-blmf (Blenrep), a B-cell maturation antigen (BCMA)–directed antibody and microtubule inhibitor conjugate, in combination with bortezomib and dexamethasone for the treatment of adults with relapsed or...
Lisaftoclax Regimens Effective in Plasma Cell Disorders
Lisaftoclax, an investigational BCL2 inhibitor, in combination with pomalidomide/dexamethasone (Pd) or daratumumab/lenalidomide/dexamethasone (DRd) led to improved outcomes for patients with relapsed or refractory multiple myeloma and for patients with AL amyloidosis, according to findings from a...
EHA Publishes Guidelines for LBCL and Multiple Myeloma
The European Hematology Association (EHA) has published two new sets of clinical practice guidelines, including its first dedicated guidelines for large B-cell lymphoma (LBCL), which was published in HemaSphere, as well as an updated set of guidelines in collaboration with the European Myeloma...
Dexamethasone-Sparing Regimen for Frail Patients With Newly Diagnosed Multiple Myeloma
In a French phase III trial (IFM2017-03) reported in The Lancet Oncology, Manier et al found that a dexamethasone-sparing regimen of daratumumab plus lenalidomide improved progression-free survival vs lenalidomide plus dexamethasone in patients with frailty and newly diagnosed multiple myeloma....
New Approvals for Thrombocytopenia, Lung Cancer, Brain Cancer, and Multiple Myeloma
BTK Inhibitor for Chronic Immune Thrombocytopenia: On September 2, 2025, the U.S. Food and Drug Administration (FDA) approved the Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib (Wayrilz) tablets to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an...
The Implications of the Results From CARTITUDE-1 for Future Research and Care in Multiple Myeloma
The results from the CARTITUDE-1 study showed the remarkable efficacy of ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy, when used in patients with relapsed or refractory multiple myeloma after four or more prior lines of...
Do the Results From CARTITUDE-1 Represent a Cure for Patients With Multiple Myeloma? We Need Longer Follow-Up to Know for Sure
The results of the CARTITUDE-1 clinical trial demonstrate outstanding and unprecedented long-term efficacy with ciltacabtagene autoleucel, a B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy in relapsed or refractory multiple myeloma.1 (See the July 2025 issue of The ...
Rare Secondary Cancer After CAR T-Cell Therapy Successfully Treated, Case Report Shows
In a case presentation published in The New England Journal of Medicine, targeted treatment was successful for chimeric antigen receptor (CAR)-positive peripheral T-cell lymphoma developed after CAR T-cell therapy for multiple myeloma. Using advanced genomic, phenotypic, and functional profiling...
Smoldering Multiple Myeloma: How the Guidance Is Changing
Clinical trials have sought to determine the benefit of treating the precursors of multiple myeloma, but as the phenotypes and genomics of this entity are becoming better delineated, the wisdom of early intervention has remained confusing for clinicians. At the 2025 Debates and Didactics in...
