At the end of each month, the International Myeloma Foundation (IMF) brings you some of the latest and most relevant news (myeloma research, clinical trials, treatments, drug authorizations, and more) to give a renewed sense of hope, courage, and resilience to the myeloma community. Through these encouraging developments that bring us closer to a cure, the IMF’s vision is slowly but surely coming to fruition: A world where every myeloma patient can live life to the fullest, unburdened by the disease. 

Consensus Recommendations 
 

International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma — Journal of Clinical Oncology (June 2025) 
 

Summary 
This report explains the 2024 IMS-IMWG Consensus Genomic Staging (CGS) system for high-risk multiple myeloma (HRMM) and is based on the latest research about the biology and genetic features of the disease.  
 
Using a clear and consistent way to define HRMM is important to help doctors better treat high-risk patients and give them more accurate information about their condition. By using the same definition in clinical trials, it will be easier to compare how well different treatments work for high-risk patients.  
 
This agreed-upon definition should also help researchers create better trials focused on HRMM patients. Because outcomes in multiple myeloma vary a lot, future treatments will likely be tailored to each patient’s risk level. The authors recommend that all future clinical trials use this CGS system to keep results consistent. 
 
This first version of the HRMM definition is based on genetic testing, which uses sequencing technology. These kinds of tests, like Next Generation Sequencing (NGS), are already commonly used for blood cancers like myelodysplastic syndrome (MDS) and Acute Myeloid Leukemia (AML).  
 
The expert panel understands that not all hospitals or regions around the world have access to this technology yet. In those cases, doctors can still use the new HRMM definition with the parts that are available, since the genetic data only applies to a small group of patients in this system. 
 
 
Why these new guidelines matter  
According to IMF Chairperson of the Board and co-author of the IMS-IMWG consensus recommendations, Dr. S. Vincent Rajkumar: “by defining HRMM in a clear, consistent, and standardized manner, we are able to help doctors and clinicians identify the condition, provide accurate information to the patient, and treat the disease more effectively. By using this definition in clinical trials, we are able to discern which treatments work best for HRMM patients —even design clinical trials that are tailored to their unique needs and risk level.”  
 
 

Reference: 
Hervé Avet-Loiseau et al. International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma. JCO 0, JCO-24-01893 DOI:10.1200/JCO-24-01893 
 
 

Imaging in plasma cell disorders—consensus recommendations of the Asian myeloma network bone imaging workgroup — The Lancet Regional Health Western Pacific (June 2025) 
 

Summary 
Published in The Lancet Regional Health - Western Pacific, these consensus recommendations were developed by the Asian Myeloma Network (AMN) Bone Imaging Workgroup using primary references which focused on well-known international guidelines as well as important papers suggested by experts on each topic.  
 
What are the objectives of the study?  

1. To record and study how imaging is used for plasma cell disorders in different countries and regions that are part of the Asian Myeloma Network (AMN), while referencing consensus recommendations from the IMWG. 
2. To find out what factors affect how doctors choose diagnostic imaging methods, and to look for ways to solve problems and remove barriers to better imaging. 

 
Why this study matters  
Because imaging methods are always changing, doctors need clear and practical advice based on the latest research and suited to their healthcare systems.  
 
Creating clear imaging guidelines for the Asian region can help raise the standard of care and convince healthcare systems to invest more in imaging tools. This report is meant to support that effort by encouraging conversations with those involved in making health policy. If these changes occur, myeloma patients in Asia could get much better care through the use of advanced imaging. 
 
This paper presents two levels of imaging recommendations (basic and advanced) for different types of plasma cell disorders. To account for different hospital resources and situations, the recommendations were divided into two levels: 

• Minimally appropriate – the basic level of care that should be met 
• Enhanced standard – the best level of care based on the latest evidence 

 
These region-specific recommendations are useful, not just in Asia, but around the world. They can help educate doctors, nurses, patients, and caregivers, and support conversations with healthcare decision-makers to improve imaging practices. 
 

Reference: 
Nagarajan, Chandramouli et al. Imaging in plasma cell disorders—consensus recommendations of the Asian myeloma network bone imaging workgroup. The Lancet Regional Health – Western Pacific, Volume 59, 101597 

Research 
 

New Definition of Light Chain Monoclonal Gammopathy of Undetermined Significance —  iStopMM Study, JAMA Oncology (May 2025) 

 

What is the purpose of the study? 
The objective of the study is to improve the definition of light chain (LC) monoclonal gammopathy of undetermined significance MGUS) to “substantially decrease false-positive diagnosis and optimize care.” 
 
To achieve its goal, the study looked at people with healthy kidneys to find better, more accurate serum free light chain (FLC) reference ranges and to suggest a new way to define LC-MGUS. 
 

How was the study conducted? 


iStopMM (Iceland Screens, Treats, or Prevents Multiple Myeloma) researchers screened over 75,000 people aged 40 and older between 2016 and 2023 for MGUS. This is the largest population-based study so far on MGUS screening. 
 
Using serum protein electrophoresis (SPEP), immunofixation electrophoresis (IFE), and FLC assay, samples were analyzed, and follow-ups were made with participants over time. 
 

What the findings revealed 


Out of about 42,000 people with good kidney function: 

• Many had abnormal FLC results using the old (standard) reference ranges. 
• When they used new, age-based reference ranges, far fewer people were labeled as having LC-MGUS. 
• For people under 70, the new normal FLC ranges were a bit lower. For those 70 and older, they were higher. 
• With the new ranges, the number of people diagnosed with LC-MGUS dropped by 82%. 
• None of the people who were only considered to have LC-MGUS under the old system developed a more serious disease during about 4.6 years of follow-up. 

 
Why this study matters 
The study concludes that by using new and more accurate FLC reference ranges to define LC-MGUS, the number of false-positive test results was reduced by 82%. This makes FLC testing more useful and reliable for doctors. Additionally, these findings could help reduce unnecessary stress and medical costs for patients, while making health care more efficient. 
 
The researchers created new, more accurate FLC reference ranges based on age (under 70 and 70 or older). However, current FLC reference ranges are not accurate for people with healthy kidneys. They lead to too many false-positive κ (kappa) and false-negative λ (lambda) test results. More research in other countries and groups is needed to confirm that these new reference ranges work for everyone. 
 

Reference: 
Einarsson Long T, Rognvaldsson S, Thorsteinsdottir S, et al. New Definition of Light Chain Monoclonal Gammopathy of Undetermined Significance. JAMA Oncol. Published online May 29, 2025. doi:10.1001/jamaoncol.2025.1285 
 

Ultrasensitive detection of circulating multiple myeloma cells by next-generation flow after immunomagnetic enrichment — Blood (May 2025) 
 

What is the purpose of this study? 
Multiple myeloma is a type of blood cancer that grows in the bone marrow. Thanks to recent treatment advances, many patients now live longer without their disease getting worse—over 80% stay in remission for at least five years if they have no minimal residual disease (MRD). But checking for MRD usually requires painful bone marrow tests. That’s why scientists are working on less invasive ways to monitor the disease. 
 
Because of this need, researchers at Cima Universidad de Navarra in Pamplona, Spain have developed a blood testing method called BloodFlow— a test that can find very low levels of leftover cancer cells (called peripheral residual disease, or PRD) in people with multiple myeloma, even below levels that older tests can detect. This makes it possible to spot patients who are at higher risk of relapse by finding tumor cells still circulating in their blood. 
 

How does BloodFlow work? 

• BloodFlow works by pulling out specific cancer cells from the blood and analyzing them with advanced technology. It detected PRD in 8.5% of patient blood samples—even when other tests could not. 
• In some cases, BloodFlow found cancer cells when standard bone marrow tests showed no signs of disease. 
• Patients who still had PRD during follow-up had a much higher risk of the cancer coming back or dying sooner.  

 

Why this study matters 
Overall, BloodFlow provides more accurate, less invasive, and earlier warning signs about disease progression than older methods, making it a useful new tool for monitoring myeloma. 
 
BloodFlow has already been tested on over 300 patients (belonging to the Spanish Myeloma Group, GEM-PETHEMA) and is now being used in other countries like the U.S. and Germany. It helps doctors better understand a patient's risk without using bone marrow biopsies, which improves patient comfort and quality of life. The research team also plans to study BloodFlow’s use in other cancers like leukemia and lymphoma. 
 

Reference: 
Marta Lasa, Carmen Gonzalez, Laura Notarfranchi, et al. Ultrasensitive detection of circulating multiple myeloma cells by next-generation flow after immunomagnetic enrichment. Blood 2025; blood.2025029234. doi: https://doi.org/10.1182/blood.2025029234 
 

Unraveling Obesity and Multiple Myeloma: Insights from Epidemiology and Molecular Mechanisms — Current Obesity Reports (June 2025) 
 

What is the purpose of this review? 


Global rates of obesity have increased considerably in recent years, causing numerous health problems. Research shows obesity can increase the risk of developing different kinds of cancer, including multiple myeloma.  
 
Obesity has been established as “a modifiable risk factor for both myeloma and its precursor stages — monoclonal gammopathy of unknown significance (MGUS) and smoldering myeloma (SMM) — the association between obesity and disease onset has become a compelling area of research,” states the study. 
 
This review gives a detailed summary of current research showing how obesity is linked to myeloma, focusing on how it influences the development of the disease and affects patient outcomes. It also explores the biological processes behind this harmful link and examines treatment approaches that target the effects of obesity on myeloma. 
 

What are recent findings about obesity? 


New studies show that obesity may not only raise the chances of getting myeloma but can also change how the disease acts in the body. Fat tissue in obese people can cause long-lasting inflammation. This happens because fat cells and immune cells in the fat release chemicals that help cancer cells grow and spread. Also, fat cells in the bone marrow can interact with myeloma cells in ways that help them develop. 
 

What are the findings of the review? 
Obesity is a risk factor for multiple myeloma that can be changed through lifestyle, making it important for prevention and treatment strategies. It increases not only the risk of developing myeloma but also the chances that early stages like MGUS will progress to active disease. Obesity is also linked to higher death rates in myeloma patients. This may be due to harmful fat tissue in the body and bone marrow, which releases substances like leptin, inflammatory molecules (IL-6 and TNF-α), and hormones like insulin, while lowering levels of protective factors like adiponectin. These changes support the growth of myeloma. 
 
The environment inside the bone—made up of different cells and surrounding materials—also plays a key role in helping myeloma grow and damage bone. New research shows how obesity can change this environment, helping myeloma develop and progress.  
 
One area of growing interest is extracellular vesicles (EVs), which are tiny packages that cells use to send messages. These EVs can carry proteins, fats, and genetic materials that help cancer cells become more aggressive and resistant to treatment. Although EVs are known to be involved in myeloma, scientists still don’t fully understand how EVs coming from obese fat tissue affect the disease. 
 

Why this review matters 
While researchers are still figuring out exactly how obesity affects myeloma outcomes, future pre-clinical and clinical studies could provide more answers to better understand their complex connection. 
 
Learning more about how obesity influences different stages of myeloma may help improve prevention, early detection, and treatments—especially through lifestyle changes. More in-depth lab research could also uncover new biological markers and treatment targets to better fight the disease. 
 

Reference: 
Manna, L., Gelsomino, L., Martino, E.A. et al. Unraveling Obesity and Multiple Myeloma: Insights from Epidemiology and Molecular Mechanisms. Curr Obes Rep 14, 52 (2025). https://doi.org/10.1007/s13679-025-00644-w 
 
 

Clinical Trials 

 

Measurable Residual Disease–Guided Therapy in Newly Diagnosed Myeloma — The New England Journal of Medicine (June 2025) 
 

Summary  
In newly diagnosed multiple myeloma (NDMM), the results of measurable residual disease (MRD) testing serve as an important guide in determining the effectiveness of treatments; deciding whether to intensify, continue, or stop treatment; and evaluating whether the patient needs an autologous stem cell transplant (ASCT). 
 
This randomized phase 3 clinical trial involves transplant-eligible, NDMM patients who have gone through induction therapy with a drug combo consisting of isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd).  
 
Participants were divided into groups, based on their MRD results, with two groups consisting of MRD-negative patients, and two other groups with patients who tested MRD-positive. 
 
For groups with MRD-negative patients: the first group received ASCT plus two cycles of Isa-KRd (ASCT group); the second group did not go through ASCT but were given six cycles of Isa-KRd (Isa-KRd group). 
 
For groups with MRD-positive patients: the first group received two ASCTs within a short period (tandem ASCT group); the second group received one ASCT plus two cycles of Isa-KRd (single ASCT group). 
 
 
What were the findings of the study? 
 
    1. In MRD-negative patients: 

• 86% of those who received ASCT became even more deeply MRD-negative (10⁻⁶ sensitivity). 
• 84% of those who skipped ASCT and got more Isa-KRd also became MRD-negative at that level. 
• The difference was very small and not significant. 

 
    2. In MRD-positive patients: 

• 32% of those who had tandem ASCTs became MRD-negative at the deeper level. 
• 40% of those who had a single ASCT and two cycles of Isa-KRd became MRD-negative. 
• The difference was not significant. 

 
 
Why this study matters 

For MRD-negative patients who skipped ASCT and received six cycles of Isa-KRd, the results worked just as well as MRD-negative patients who received ASCT and two cycles of Isa-KRd. 
 
For MRD-positive patients, doing tandem ASCTs did not lead to better results compared to those who received one ASCT plus two cycles of Isa-KRd. 
 
This suggests personalizing treatment based on MRD results could be helpful, but more research is needed. 
 
Reference: 
Perrot A, Lambert J, Hulin C, Pieragostini A, et al; MIDAS Study Group. Measurable Residual Disease-Guided Therapy in Newly Diagnosed Myeloma. N Engl J Med. 2025 Jun 3. doi: 10.1056/NEJMoa2505133  
 

 

A High-Fiber Plant-Based Intervention in Precursor Plasma Cell Disorders Improves Dietary Quality and Microbiome — Memorial Sloan Kettering Cancer Center (Presented at NUTRITION 2025, American Society of Nutrition) 
 

What is the purpose of the clinical trial? 


Multiple myeloma usually develops after earlier conditions called MGUS and smoldering myeloma (SMM). High body weight, poor diet, and an unhealthy gut microbiome are known risk factors for these conditions and their progression into myeloma. 
 

How was it conducted? 


In this single-arm pilot trial, 20 people with MGUS or SMM, and with a BMI of 25 or higher took part in a 12-week high-fiber, plant-based diet (HFPBD) program, along with 24 weeks of behavioral counseling. Participants tracked their food each week, and their diets were analyzed for quality and fiber content. Researchers looked at how well participants adhered to the diet, if there were any changes in BMI, and effects on the gut microbiome. 
 

What were the findings of the study? 


The plant-based diet was safe, easy to follow, and helpful in improving diet quality and microbiome. Participants adhered to the diet much better by the end of the 12 weeks (going from 20% to 91% adherence). Their BMI dropped by about 6.6%, and fiber intake doubled. Diet quality scores (HEI-2020) improved, and the diversity of their gut microbiome increased. There was a rise in healthy gut bacteria that produce butyrate, which is linked to better health. These changes were still seen at 24 and 52 weeks. 
 

Why this study matters 


This is the first study to show that a high-fiber, plant-based diet can improve diet quality and gut health in people at risk for myeloma. These results suggest that dietary changes could help slow or prevent the progression from MGUS/SMM to myeloma, especially since no other diet-based interventions have been studied in blood cancers before. 
 
In a news article, principal investigator of the study Dr. Urvi A. Shah said: "With everything that patients cannot control during and before cancer treatment, studying diet provides an opportunity for patients to make a difference in their disease risk and the potential success of their treatment. Our study shows the power of nutrition in the preventative setting and showcases the potential to give patients a sense of agency in their diagnosis." 
 

Reference: 
Francesca Castro, MS, RD, CDN, Urvi A. Shah, MD, et al. A High-Fiber Plant-Based Intervention in Precursor Plasma Cell Disorders Improves Dietary Quality and Microbiome, Memorial Sloan Kettering Cancer Center (Presented at NUTRITION 2025, American Society of Nutrition) 
 
 

Drug Authorization 
 

NICE Approves ‘Trojan Horse’ Targeted Therapy for Myeloma Patients in England 
 

On Thursday, June 12, the National Institute for Health and Care Excellence (NICE) approved the use of belantamab mafodotin— “an antibody-drug conjugate (ADC), a type of treatment which targets and attaches to cancer cells,” states the National Health Service (NHS) of England via press release. 

Belantamab mafodotin “has been described by researchers as ‘trojan horses’ as they are designed to be taken up by the cancer cell, before releasing a high concentration of a lethal molecule to destroy the cell from within” and “will be offered to eligible patients whose cancer has progressed or not responded to first-line treatment with another drug, lenalidomide,” the NHS further stated. 

According to the NHS, in clinical trials, patients with relapsed or refractory multiple myeloma (RRMM) lived without their disease getting worse for about three years when treated with belantamab mafodotin, bortezomib, and dexamethasone. This is much longer than the just over one year seen in patients who took the commonly used drug daratumumab along with bortezomib and dexamethasone. 
Progression-free survival (PFS) data for the smaller group of patients for whom the ADC is being recommended, is currently not available to the public. 

Eligible patients will receive the new drug as an infusion every three weeks, along with bortezomib (given by injection) and dexamethasone (taken by mouth). NHS England is speeding up access to this treatment through the Cancer Drugs Fund. 

NHS England National Clinical Director for Cancer Prof. Peter Johnson said that he is “delighted that patients in England will be the first to benefit from this new treatment, which has the potential to keep cancer at bay for years longer, giving people the chance of more precious time with friends and family.”  

“This treatment could be life-changing for many patients and their families, and that’s why it is so important that the NHS continues to secure quick access to the latest, innovative treatments like this, at affordable prices to the taxpayer,” he further added. 

According to a NICE press release, the full draft guidance is open for people and organizations to make comments and share their views on the recommendations until July 3, 2025. After all comments and views have been considered, the guidance will be finalized and will become the basis for NICE’s recommendations for using the drug combination in the NHS. Once the guidance is finalized and published, belantamab mafodotin will become readily available through the Cancer Drugs Fund.  

The full draft guidance can be viewed at the NICE website.   

 

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 
 

CHMP Recommends EU Approval of DARZALEX® (daratumumab) as Monotherapy for the Treatment of High-Risk Smoldering Myeloma  
 

On Friday, June 20, Johnson & Johnson announced in a press release that "the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a new indication for DARZALEX® (daratumumab) subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with smoldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. If approved, daratumumab could shift the treatment paradigm by becoming the first approved therapy for this disease." 
 
 
The CHMP recommendation is based on the results of the Phase 3 AQUILA study, which looked at the effectiveness and safety of daratumumab SC monotherapy for treating high-risk smoldering multiple myeloma (SMM) compared to active monitoring (“watch and wait”). On November 8, 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for approval to use daratumumab SC to treat adults with high-risk SMM, based on the AQUILA study results.  
 
The first results of this study were shared at the 2024 ASH Annual Meeting and published in the New England Journal of Medicine. Currently, daratumumab is approved for use in nine indications to treat multiple myeloma, including five as early treatment. 
 
“The positive recommendation from the CHMP marks an important step towards addressing the needs of people living with high-risk smoldering multiple myeloma. Early disease intervention with daratumumab has the potential to reduce the risk of progression to active multiple myeloma or death by 51 percent for patients with high-risk disease. Pending European Commission approval, patients and physicians will have an option to treat high-risk smoldering multiple myeloma, with the aim to intercept this complex blood cancer before it develops into active disease and importantly, before end-organ damage occurs,” said Ester in’t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 
 
 

CHMP Recommends EU Approval of SARCLISA® (isatuximab-irfc) as Treatment for Transplant-Eligible Newly Diagnosed Multiple Myeloma 

 

In a press release on June 23, Sanofi announced that “the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months.” 

The CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study, presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology. 
 
 
“The CHMP’s recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment,” said Olivier Nataf, Global Head of Oncology at Sanofi. 
 
Results of the first phase 3 GMMG-HD7 study revealed that using an anti-CD38 treatment during early therapy leads to a deep and rapid response in transplant-eligible NDMM patients. More patients reached minimal residual disease (MRD) negativity after initial treatment. Patients also had longer progression-free survival, no matter what follow-up treatments they received and even without extra therapy before the transplant. 

The study also showed the highest MRD negativity rates after both initial treatment and transplant when using a CD38 antibody with VRd. These results support using Sarclisa with VRd as a strong treatment option before a transplant. 

Currently, Sarclisa is approved in the EU for three types of treatment in adults with relapsed or refractory multiple myeloma, and for newly diagnosed myeloma patients who are transplant-ineligible. 

For the latest, up-to-the-minute news on multiple myeloma, visit the IMF Newsroom.