Chief Mission Officer Multiple Myeloma Research Foundation
Background: The MMRF CureCloud® is a novel direct-to-patient registry study that aims to accelerate research and advance precision medicine approaches for myeloma patients. Opened in July 2020, it is a first-of-its-kind, IRB-approved longitudinal study featuring at-home genomic testing using a clinical-grade liquid biopsy. Genomic, clinical, patient-reported-outcome (PRO) and other information are de-identified and aggregated into a comprehensive data hub for use by patients, clinicians, and researchers. The enrollment goal is 5,000 patients over 5 years.
Process: To remove barriers to participation, patients consent on-line from home and results of genomic testing are returned to both patients and their doctors at no cost. This is enabled by a mobile phlebotomist visit to the patient’s home for the blood draw. Circulating cell-free tumor DNA from the patients’ blood undergoes sequencing using a myeloma-specific 70-gene assay. Additionally, electronic health records (EHRs) are collected to provide a comprehensive profile of patients’ medical history. Patients are followed for the duration of the study and continue to be active participants over the course of their treatment journey.
Impact/Innovation: CureCloud empowers patients by providing information to facilitate patient-clinician communications and, in some cases, inform treatment decisions. Genomic reports identifying tumor mutations that may be actionable along with potential matching clinical trials, are provided to physicians and patients. Patient reports use language developed in partnership with genetic counselors. Patients can also access a personal dashboard where they can view their medical history and lab results combined with genomic information, if applicable.
Further, all myeloma patients, physicians, and researchers will have access to the de-identified, aggregated data in CureCloud. Researchers will be able to gain insights into the biology of myeloma and treatment response over time, investigating regimens across all participants. Any patient can view anonymous demographic, disease stage, and genetic alteration data contributed by study participants using dynamic data visualizations on the CureCloud website. Over the course of the study, patients and their physicians will be able to compare their treatment path to others who share similar characteristics and/or treatment history to better inform treatment decisions.
Discussion: Through July 2022, 969 patients consented to the study, 628 patient blood samples have been sequenced, 623 patients have received their sequencing reports, and 247 patients have fully curated EHR data. Patient diversity in most variables (including age, sex, and geography), apart from race and ethnicity, have been achieved. Fewer actionable mutations have been detected than expected and the retrieval, curation, and integration of EHR data has proven to be labor intensive. Ongoing efforts are underway to identify optimal sequencing assays and create greater efficiencies around retrieving and curating EHR data.
Initiatives are in progress to ensure representation proportionate to the demographics of myeloma patients, including partnerships with clinical institutions committed to population engagement to directly enroll diverse patients. In summary, this unique patient-centric research study is ongoing and is expected to produce unique insights to help inform both the execution of such a study type, as well as the optimal treatment of multiple myeloma.
