Imaging Strategies in Multiple Myeloma Clinical Trials: Precision, Protocols, and Progress
Imaging is vital for diagnosing, staging, and monitoring multiple myeloma (MM) in clinical trials. Common imaging methods include Whole-Body Low-Dose CT, ideal for initial MM-related lytic bone lesion assessment; MRI, the gold standard for detecting bone marrow involvement; and 18F-FDG PET/CT, which offers valuable prognostic insights and is preferred for therapy response evaluation. These imaging techniques have transformed the way MM clinical trials are conducted, ensuring precision in assessing disease progression and treatment outcomes.
Multiple myeloma (MM) is a heterogeneous plasma cell malignancy characterized by bone marrow infiltration, excess M protein, and associated complications like lytic bone lesions, hypercalcemia, and extramedullary plasmacytomas. It is the second most common hematologic malignancy after lymphoma, with peak incidence between ages 60-70. Current clinical trials emphasize achieving Minimal Residual Disease (MRD) negativity as a key endpoint, correlating it with improved PFS and OS. MRD negativity has emerged as a predictor of long-term therapeutic success, driving modern trial designs to focus on this critical measure.
MM is marked by findings referred to as CRAB: hypercalcemia, renal insufficiency, anemia, and bone lesions. Essential diagnostic tools for detecting and quantifying M protein include Serum Protein Electrophoresis (SPEP) and Urine Protein Electrophoresis (UPEP). SPEP identifies M protein in the blood, while UPEP detects light chains in urine, often supplemented by immunofixation and serum free light chain assays. Advanced imaging technologies like PET/CT are crucial for identifying active disease and assessing treatment response.
Imaging Endpoints (IE) focuses on designing customized and optimized imaging charters for MM clinical trials, which are vital for ensuring consistency and standardization while ensuring alignment between the trial’s goals and the imaging plan. IE collaborates with sponsors to create detailed charters tailored to each study’s unique needs, addressing all imaging aspects from acquisition parameters to response evaluation criteria. This novel approach not only improves patient care but also generates robust data that optimizes the opportunity to demonstrate efficacy.
We have worked with sponsors to align imaging with recent advancements in BCMA-targeted therapies, proteasome inhibitors, CAR T-cell therapy, bispecific T-cell engagers, ADCs, and Mabs, to significantly improve outcomes in relapsed/refractory MM (RRMM).
With a proven track record in imaging expertise in optimizing and applying the IMWG criteria and data delivery, IE is the recognized leader for support of your multiple myeloma clinical trials. To connect with us to begin a conversation with our medical, scientific and regulatory experts to explore how we can support your clinical trial.
