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Dr. Charlotte Pawlyn – Majestec-3

Dr. Charlotte Pawlyn from The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, UK, explains the main results of MajesTEC-3, one of the most important myeloma studies. This trial compared the combination of teclistamab and daratumumab (Tec-Dara) versus daratumumab with either pomalidomide or bortezomib and dexamethasone in patients who had received one to three previous lines of treatment. The Tec-Dara combination showed unprecedented benefits when used earlier in the myeloma pathway.

Dr. Phoebe Joy Ho – inMMyCAR

Dr. Phoebe Joy Ho from the Royal Prince Alfred Hospital and the University of Sydney, Australia, explains the results of inMMyCAR. This first-in-human study of KLN1010, a novel “in vivo” CAR T-cell therapy targeting BCMA, showed very good responses in four treated patients with no serious instances of cytokine release syndrome (CRS) or neurotoxicity (ICANs).

Dr. Bruno Paiva – GEM-CESAR

Dr. Bruno Paiva, Clínica Universidad de Navarra, Madrid, Spain, explains the main results of the GEM-CESAR clinical trial presented at ASH 2025. This a study assessing early rescue treatment with daratumumab, pomalidomide and dexamethasone (DPd) in people with high-risk smoldering myeloma.

Dr. Shambavi Richard – DURGA-1

Dr. Shambavi Richard, Icahn School of Medicine at Mount Sinai, New York, United States, explains the main results of the DURGA-1 trial evaluating AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy using FasTCAR technology for rapid manufacturing. Early data showed promise for this dual-target approach in relapsed/refractory multiple myeloma patients.

Dr. Xavier Leleu –  LINKER-MM4

Dr. Xavier Leleu, Centre Hospitalier Universitaire de Poitiers, France, explains the main results of the LINKER-MM4 clinical trial which evaluates safety and efficacy of linvoseltamab as a simplified monotherapy in first-line regimen in newly diagnosed myeloma patients.

Dr. Charlotte Pawlyn – UK MRA FiTNESS trial 

Dr. Charlotte Pawlyn, from The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, UK, explains the main results of the MRA FiTNESS trial, which aims to understand whether the International Myeloma Working Group (IMWG) frailty score can be used to tailor treatment according to a myeloma patient’s level of fitness.

Dr. Phoebe Joy Ho – CAMMA-3

Dr. Phoebe Joy Ho, Royal Prince Alfred Hospital and University of Sydney, Australia, explains the first results from the phase Ib CAMMA-3 study, in which subcutaneous cevostamab shows manageable safety and meaningful clinical activity in relapsed/refractory myeloma (RRMM).

Dr. Dominik Dytfeld – COBRA trial

Dr. Dominik Dytfeld, Poznan University of Medical Sciences, Poland, lead author of the COBRA trial, explains this study evaluating carfilzomib, lenalidomide and dexamethasone (KRd) versus bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma (NDMM).

Dr. Bruno Pavia – NoMoreMGUS

Dr. Bruno Paiva, Clínica Universidad de Navarra, Madrid, Spain, explains the main results of the NoMore MGUS clinical trials, one of the largest MGUS (Monoclonal Gammopathy of Undetermined Significance) data collection trials in the world.

Dr. Salomon Manier – IFM2021-01 trial

Dr.Salomon Manier, University of Lille, France, talks through this teclistamab trial. This study shows that an “all-antibody–based” doublet regimen of teclistamab and daratumumab is highly effective and well-tolerated in elderly newly diagnosed myeloma patients. 

Dr. Paolo Milani – AL amyloidosis highlights

Dr. Paolo Milani, University of Pavia, Italy, explains for MPE the most important AL amyloidosis updates presented at ASH 2025, as well as the role of the CAR T-cell therapy in this disease or the main challenges AL amyloidosis is facing to improve treatment outcomes.

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This means that the trial failed to demonstrate that newly diagnosed AL amyloidosis patients, with severe heart involvement (Mayo Stage IV), had an improved survival from taking birtamimab.

The AFFIRM-AL trial was also looking at two secondary endpoints, both of which were also not met. These were a 6-minute walk test distance and a Short Form-36 version 2 Physical Component Score. Both secondary endpoints were looking at the impact of birtamimab on patients’ physical function and ability to exercise.

In their press release, Prothena announced that they will no longer be developing birtamimab in AL amyloidosis because of the negative results. This includes stopping an open-label extension of the AFFIRM-AL clinical trial. If you have any questions or concerns, please speak to your doctor or nurse. You can also contact MPE at info@mpeurope.org.

What is birtamimab?

Birtamimab is a monoclonal antibody designed to bind to amyloid protein deposits, which accumulate in tissues and organs, leading to damage and eventual organ failure. By engaging the patient’s immune system, it was hoped that birtamimab would work to remove these harmful deposits from affected organs and tissues.

What was the AFFIRM-AL?

The Phase III AFFIRM-AL clinical trial was assessing the safety and effectiveness of birtamimab when given in combination with standard of care (SoC) chemotherapy in 207 newly diagnosed AL amyloidosis patients with Mayo Stage IV disease. Mayo Stage IV is the most severe stage of the disease, where the heart is significantly affected, making it harder for it to pump properly due to protein buildup.

Patients either received birtamimab in combination with SoC chemotherapy or placebo with SoC chemotherapy. SoC chemotherapy consisted of cyclophosphamide, bortezomib, and dexamethasone, with use of daratumumab permitted.

The “open label” part of the trial refers to a planned extension where patients would be able to receive the birtamimab for an additional 24 months or until the medication became available in their country. This extension of the trial has now been cancelled.

What are the next steps?

As Prothena have indicated they will no longer be developing birtamimab this means clinical trials exploring the drug will be discontinued. MPE will speak to Prothena to understand exactly what this means for patients who are currently enrolled in the clinical trial. In the meantime, if you have any questions or comments please speak to your doctor or nurse.

If you have any questions for MPE, please email info@mpeurope.org.

You can read the company’s press release here.

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Aimed at AL amyloidosis patients and patient advocates, the webinar will feature presentations on supportive care for patients.

Prof. Dr. Monique Minnema, Haematologist at the University Medical Centre Utrecht, will focus her presentation on managing the symptoms of AL amyloidosis and the side-effects of treatment. This will include topics such as recovering from transplantation and managing pain.

Karin Aarsman, Haematology Nurse Practitioner, also at the University Medical Centre Utrecht, will then present an overview of the role of nurse specialists in assisting patients with living well with AL amyloidosis. This will cover topics such as nutrition and fatigue.

All participants will have the opportunity to participate in a moderated Q&A session.

Meet the experts

Prof. Dr. Monique Minnema, Haematologist, University Medical Centre Utrecht, the Netherlands, was trained as internist and haematologist at the Academic Medical Center, Amsterdam and the University Medical Center, Utrecht, in the Netherlands. She started working as a haematologist in 2005 at the department of haematology, UMC Utrecht and was appointed full professor in 2019. She is a myeloma and AL amyloidosis specialist. She is the author on several national and international guidelines on the diagnosis and treatment of plasma cell diseases. She is founder and medical lead of the haematology clinical research team of the UMC Utrecht. Monique Minnema is a clinical researcher and participated in many breakthrough clinical trials, her main focus of clinical research is the development of novel therapies and new research structures for haematology research in the Netherlands.

Karin Aarsman is a Nurse Practitioner in Haematology. She is part of the multidisciplinary Amyloidosis team at the UMC Utrecht Center of Expertise in the Netherlands. She thinks enhancing awareness to promote earlier recognition of AL amyloidosis and timely referral is an important mission. In her role, she is committed to delivering personalised care and ensuring close collaboration between the various disciplines involved. She has many years of experience in oncology nursing, haematology and stem cell transplantation.

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You can also watch the MPE ASH 2024 highlights webinar recording here.

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Myeloma Patients Europe (MPE) will attend the meeting to learn and share updates about the most significant developments in myeloma and AL amyloidosis. MPE will also meet with members, sponsors, European and US advocacy groups, myeloma doctors, researchers and other stakeholders to discuss ongoing projects and future collaborations.

Stay tuned to our social media accounts (Facebook, LinkedIn, Twitter) for the latest information during the conference. MPE will be filming and posting interviews with leading researchers throughout the Meeting.

MPE will also host an ASH highlights webinar on 18 December at 17:00 CET.

MPE´s Head of Medical Education and Scientific Engagement, Solène Clavreul, is also a co-author on a poster being presented on Sunday, 8 December. The poster is entitled Examining Discrepancies in Perspectives of Healthcare Providers and Patients With Relapsed/Refractory Multiple Myeloma on Novel Therapies Across Diverse Clinical Landscapes: An International Prospective Study. You can find further information here.

PROGRAMME HIGHLIGHTS

The programme for myeloma and AL amyloidosis this year is extensive and rich, with a range of research focusing on the science underlying myeloma and on the anti-myeloma effect of existing and new medicines. Given the extensive programme, it is difficult to summarise every presentation, but MPE believes the following myeloma and AL amyloidosis data will be of greatest interest to patients:

AL Amyloidosis

There will be several presentations on the treatment of AL amyloidosis. In particular, results of the ISAMYP study will be presented. The study conducted in multiples sites in France and Australia is evaluating the efficacy and safety of the combination of isatuximab, pomalidomide and dexamethasone (IsaPd), in AL amyloidosis patients with suboptimal response to previous therapy or at relapse.

• Efficacy and Safety of Isatuximab, Pomalidomide and Dexamethasone in Relapsed AL Amyloidosis: Interim Results of the Isamyp Phase 2 Joint Study from the IFM and ALLG. Click here for details. Monday, December 9, 2024: 3:30 PM (GMT-8)

Smouldering myeloma

There are few presentations of interest that will focus on the outcomes of patients with smouldering myeloma. In the years to come, it will be important to understand when it is best to start treatment. The Aquila study is investigating whether daratumumab monotherapy could delay progression to myeloma compared active monitoring in patients with high-risk smouldering myeloma and preliminary results will be presented during the meeting.

• Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients with High-Risk Smouldering Multiple Myeloma: Primary Results of the Aquila Study. Click here for details. Monday, December 9, 2024: 11:30 AM (GMT-8)

The CAR PRISM study is investigating, for the first time, the safety and efficacy of the use of Ciltacabtagene Autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy in patients with high-risk smouldering myeloma, without induction therapy, and will present the results observed in the first 6 patients of the study.

• Early Safety and Efficacy of CAR-T Cell Therapy in Precursor Myeloma: Results of the CAR-PRISM Study Using Ciltacabtagene Autoleucel in High-Risk Smouldering Myeloma. Click here for details. Monday, December 9, 2024: 4:30 PM (GMT-8)

Myeloma

There will be several talks dedicated to the treatment of newly diagnosed myeloma. As tolerance to treatment vary among patients, the IFM2017-03 study is investigating the efficacy and safety of the daratumumab, lenalidomide and dexamethasone combination without long term dexamethasone compared to a lenalidomide and dexamethasone combination with long term dexamethasone in a frail population of patients with newly diagnosed myeloma. Positive results may lead to a decreased use of dexamethasone and therefore an improved quality of life for patients.

• The IFM2017-03 Phase 3 Trial: A Dexamethasone Sparing-Regimen with Daratumumab and Lenalidomide for Frail Patients with Newly-Diagnosed Multiple Myeloma. Click here for details. Monday, December 9, 2024: 11:45 AM (GMT-8)

Some results of the MajesTEC-5 study on the addition of teclistamab to daratumumab-based induction regimens before stem cell transplant will be presented. These combinations are hoped to increase long-term disease-free survival of newly diagnosed myeloma patients.

• Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial. Click here for details. Sunday, December 8, 2024: 9:30 AM (GMT-8)

The ASH congress will also see a range of oral and poster presentations exploring the role of CAR T-cell therapies and bispecific antibodies used as single agents or in combination with already approved treatments, and newly developed trispecific antibodies in the treatment of relapse refractory myeloma.

• Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Preliminary Results from the IMMagine-1 Trial. Click here for details. Monday, December 9, 2024: 5:30 PM (GMT-8)
• Efficacy of Elranatamab (ELRA) in Combination with Carfilzomib (CFZ) and Dexamethasone (DEX) in the Phase 1b MagnetisMM-20 Trial in Relapsed or Refractory Multiple Myeloma (RRMM). Click here for details. Monday, December 9, 2024: 5:15 PM (GMT-8)
• First Results of a Phase 1, First-in-Human, Dose Escalation Study of ISB 2001, a BCMAxCD38xCD3 Targeting Trispecific Antibody in Patients with Relapsed/Refractory Multiple Myeloma (RRMM). Click here for details. (GMT-8)

Results on other types of treatments will be also presented. If approved, these new agents and combinations will provide more treatment options for relapse refractory myeloma patients. In particular, the results of a study investigating the safety and efficacy of the Cereblon E3 ligase modulatory drug (CELMoD) mezigdomide (a new generation of IMID) in combination with dexamethasone and bortezomib or carfilzomib will be presented.

• Mezigdomide (MEZI) Plus Dexamethasone (DEX) and Bortezomib (BORT) or Carfilzomib (CFZ) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from the CC-92480-MM-002 Trial. Click here for details. Monday, December 9, 2024: 5:30 PM (GMT-8)

The safety and efficacy results of a new oral agent called inobrodib will also be presented. Inobrodib is a small molecule inhibitor drug which disrupts the growth of cancer cells. This treatment could provide patients with an oral-only treatment option at late treatment lines.

• Tolerability and Clinical Activity of Novel First-in-Class Oral Agent, Inobrodib (CCS1477), in Combination with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Click here for details. Monday, December 9, 2024: 5:00 PM (GMT-8)

As treatment options can become burdensome for patients and leading to cumulative side effects, it is important to understand when it is safe to stop treatment to preserve quality of life and clinical outcomes. A study conducted in Germany investigated patients’ preferences on treatment free intervals to better tailor treatment plans to patients’ needs and desires.

• Balancing Treatment Intervals and Quality of Life in Multiple Myeloma Patients: Patient Perspectives and Recommendations. Click here for details. Saturday, December 7, 2024: 2:15 PM

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The webinar will be held on Wednesday, 18 December 2024, from 17:00 – 18:00 CET. It will be led by Dr. Charlotte Pawlyn, a haematologist and clinician scientist, who will share insights into the latest findings and developments presented at ASH 2024.

If you are unable to attend, you can submit your questions in advance to info@mpeurope.org, and we will ensure they are addressed during the session. A recording of the webinar will be made available after the event.

Meet the speaker: Dr. Charlotte Pawlyn

Dr. Charlotte Pawlyn is a CRUK Clinician Scientist and Team Leader at the Institute of Cancer Research and an Honorary Consultant Haematologist at The Royal Marsden Hospital in London, UK.

She earned degrees in Pharmacology and Medicine from St John’s College, Cambridge University. Her current research focuses on identifying therapeutic targets for patients with immunomodulatory drug-resistant and high-risk myeloma.

In addition to her laboratory work, Dr. Pawlyn works in clinical trials as part of the UK Myeloma Research Alliance, contributing to large national frontline studies such as Myeloma XI and Myeloma XIV.

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The webinar took place on 16th April 2024 and was given by Dr. Moshe Gatt, Physician Researcher Haematologist at the Hebrew University of Jerusalem, Israel, along with two AL Amyloidosis patients from Israel, Naphtali Mastboim and Melvin Granatstein.

Watch the recording below:

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Solène Clavreul, PhD, Head of Medical Education and Scientific Engagement at MPE, explained:

“Many patients are not aware of clinical trial options. The Navigator will be useful to help myeloma and AL amyloidosis patients find clinical trials in their own country and in Europe. It will also help patient advocates to analyse the clinical trial landscape in Europe and advocate for better access to clinical trials in their country.”

 Dr. Claudio Cerchione, Haematology Unit, Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” (IRST IRCCS), Italy, and member of MPE’s Medical Advisory Committee, said:

“The Navigator is a great opportunity for both patients and caregivers and myeloma physicians and researchers. It can help to look for the best therapeutic opportunity in the current setting of disease and to help centres to refer patients.”

 The Navigator offers an easy way to search for clinical trials by selecting only the relevant condition. The platform allows an advanced search to select characteristics such as the study phase, recruitment status, type of medicine or results availability, among others. The Navigator also provides the option of locating the selected clinical trials in a map for the user to know in which country and which centre the clinical trials are taking place.

The Navigator is currently available in English but will be available in many more European languages in the future.

Lise-lott Eriksson, president of MPE explained:

“Unlike other clinical trial search tools, the Navigator stands out for its patient-friendly interface, easy to navigate for patients and caregivers. One other advantage from a patient perspective is that it can be used in different languages. It serves as a vital tool for patient organisations and advocates, driving forward patient-centric healthcare and cross-border collaboration in drug development and clinical research.”

Dr. Claudio Cerchione also commented:

“The platform is simple to use. It is so important to be able to find, not only which trials are available (and which ones are opening soon) in our country, but also their location. This could help the connection between clinical institutions and allow us to provide the opportunity to access trials for all patients.”

About myeloma

 Myeloma is a rare and incurable cancer of the bone marrow and accounts for approximately 1% of cancers.  Approximately 50,000 people in Europe are diagnosed each year with myeloma. Myeloma is a relapsing-remitting cancer: patients will start treatment and may enter a period of remission before reappearance of symptoms. During remission phases, patients will either continue on the treatment that is keeping their myeloma at bay, they may receive a single drug maintenance treatment or undergo observation. Relapses can occur several times during the course of myeloma, when it is again necessary to start or change treatment. The treatment landscape of myeloma is very complex and can include a stem cell transplant and combinations of three to four drugs at a time, such as chemotherapy, immunotherapy, and steroids. Survival rates of myeloma patients have significantly improved over the last decade with the development of new and emerging treatments.

About Myeloma Patients Europe (MPE)

Myeloma Patients Europe (MPE) is an umbrella organisation of myeloma and AL amyloidosis patient groups across Europe. MPE currently has 52 members based in 33 countries. The mission of the organisation is to provide education, information, and support to member groups and to advocate at European, national, and local levels for the best possible research and equal access to treatment and care. To achieve its aims, MPE works directly with members, healthcare professionals, reimbursement authorities, regulators, politicians, pharmaceutical companies, and the media to ensure all stakeholders collaborate to improve patient outcomes and reduce inequalities across Europe.

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