FDA publishes guidance documents on expanding cancer clinical trial participation
Only a small proportion, <5%, of patients with cancer currently undergoing treatment are enrolled in clinical trials. The US FDA’s Oncology Center of Excellence published final guidance documents intended for Industry, Institutional Review Boards, and investigators, addressing the role of Performance Status, Washout Periods and Concomitant Medications, and Laboratory Values in establishing trial eligibility criteria.
The presence of t(11;14) translocation predicts post-transplant MRD-positivity
Measurable residual disease (MRD) prognosticates survival outcomes in multiple myeloma (MM). In an analysis that included 814 patients with MM who underwent transplantation, presence of t(11;14) and less than complete response prior to transplant were independent predictors of post-transplant MRD-positivity. The report in Blood Advances also outlined the association between post-transplant MRD-positivity and inferior survival outcomes.
Automated method for computing Deauville Score is feasible, predicts survival
The Deauville Score (DS) is an [18F]FDG PET/CT imaging-based 5-point scale used for monitoring disease activity and defining metabolic response in MM. To improve reproducibility of DS computation, researchers developed an automated pipeline based on baseline [18F]FDG PET/CT imaging data for patients with newly diagnosed MM. The automated pipeline —autoDS-PET — is available as an open source tool. Per the report in the European Journal of Nuclear Medicine and Molecular Imaging, autoDS-PET was feasible, and when combined with genomic and clinical features, predicted progression-free survival.
Emerging options challenge optimal approach for early RRMM
Recent data from the phase 3 MajesTEC-9, MajesTEC-3, and MonumenTAL-3 studies demonstrate the efficacy of bispecific antibody (bsAb)-based therapies for treating patients with relapsed/refractory MM (RRMM) as early as first relapse. Teclistamab-daratumumab combination therapy has also received regulatory approval based on MajesTEC-3 findings. A News & Views article in Nature Reviews Clinical Oncology discusses the questions raised by the MonumenTAL-3 findings about optimal treatment integration and sequencing. These questions will also take center-stage at the “How to Treat At First Relapse?” session at the 2026 IMS Annual Meeting.
Review explores evidence on de-escalation approaches in myeloma
Continuous therapy until disease progression or intolerable toxicity has been a long-standing paradigm in MM, challenged by recent fixed-duration therapy studies and development of increasingly effective treatments. A review published in Nature Reviews Clinical Oncology explores the state of evidence for de-escalation strategies in MM, including dose/schedule modifications, fixed-duration therapies, MRD-adapted treatment, and use of a single infusion of CAR-T cells.
High-peak ALC predicts non-ICANS neurotoxicities in cilta-cel recipients
Non-immune effector cell-mediated neurotoxicity syndrome (non-ICANS) neurotoxicities (NINTs), such as parkinsonism and neuropathy, are rare, atypical neurologic adverse effects associated with CAR-T therapies. High-peak absolute lymphocyte count was identified as a strong predictor of NINTs in patients who received ciltacabtagene autoleucel, in a study published in Science Translational Medicine.
Why Become a Member
The International Myeloma Society is a professional, scientific, and medical society established to bring together clinical and experimental scientists involved in the study of myeloma. The purpose of this society is to promote research, education, clinical studies (including diagnosis and treatment), workshops, conferences, and symposia on all aspects of multiple myeloma worldwide.
The IMS is a membership organization comprised of basic research scientists, and clinical investigators in the field along with physicians and other healthcare practitioners.
