Black Swan Initiative: Multi-Pronged Research Strategy Targets Multiple Myeloma Cure
By Bio-IT World Staff
June 18, 2025 | The International Myeloma Foundation's ambitious Black Swan Research Initiative is orchestrating a global collaborative effort to achieve what has long eluded researchers: a true cure for multiple myeloma. Through research partnerships spanning five continents, the initiative is systematically testing multiple therapeutic approaches while revolutionizing how cancer drug approvals are evaluated.
The Black Swan Initiative’s research and expertise led to a unanimous 12-0 vote by the FDA's Oncology Drug Advisory Committee (ODAC) establishing minimal residual disease (MRD) testing as a clinical trial endpoint that predicts progression-free and overall survival for drug approval.
This development could save billions of dollars in clinical trial costs while accelerating drug approvals for patients. Traditional oncology drug approvals required very long-term trials to demonstrate how many patients they put and keep in remission. MRD testing can predict who will stay in remission early in treatment, dramatically shortening the drug development timeline, potentially saving billions of dollars on clinical trials as well as faster drug approvals for patients.
CAR T-Cell and Combination Therapies
California-based researchers within the initiative are advancing modern CAR T-cell therapy, training patients' own immune cells to attack their cancer. These personalized immunotherapy approaches could potentially be applied to cure trials, representing a paradigm shift from traditional chemotherapy to harnessing the body's immune system.
The initiative has also contributed to the recent approval of two new myeloma drugs, Elrexfio and Talvey, approved by the FDA two years ago. Post-approval research is now addressing critical questions about these immunotherapy drugs, including their use in the one-third of myeloma patients with kidney complications who were excluded from original clinical trials.
Iceland's Unique Genetic Advantage
Another study that is part of the initiative is based in Iceland. The iStopMM (Iceland Screens, Treats, or Prevents Multiple Myeloma) study represents an unprecedented population-scale research effort that leverages Iceland's unique genetic and healthcare infrastructure. Over 80,000 Icelanders have consented to blood testing, with over 75,000 samples already processed, creating the world's largest screening study for myeloma precursor conditions.
Iceland's advantages include comprehensive genome sequencing through deCODE Genetics laboratory and a unified healthcare system that facilitates seamless sample collection. The study will determine whether screening asymptomatic people for precursor conditions saves lives, similar to mammograms for breast cancer or colonoscopies for colorectal cancer.
Expected outcomes include determining the real incidence of MGUS (monoclonal gammopathy of undetermined significance) and SMM, refining disease definitions, and identifying predictive variables for bone marrow biopsy requirements.
Coordinated Multi-National Approach
The Black Swan Initiative operates through a coordinated network connected via the IMF Global Technology Platform, bringing together specialized expertise from multiple countries. Spanish researchers lead immune and blood monitoring plus single-cell resistance analyses, while Australian teams conduct blood DNA mutational analyses and clinical trial assessments.
German institutions contribute family and retrospective studies, Singapore operates a virtual tissue bank for research data sharing, and U.S. centers conduct MRD testing. This distributed approach maximizes specialized expertise while maintaining collaborative coordination through regular virtual and in-person meetings.
The collaborative has produced 69 publications and 30 abstracts to date, demonstrating significant research productivity while maintaining individual institutional recognition for contributions.
Read Deborah Borfitz’s full story at Clinical Research News.