CareAcross Launches DigiMyQoL Clinical Trial, a Platform for Managing Side Effects of Multiple Myeloma Treatments, Including Daratumumab
A New Challenge for Digital Healthcare Platforms
Multiple Myeloma, a type of cancer characterized by abnormal plasma cell proliferation, is a difficult-to-treat blood cancer, and patients often experience severe side effects during treatment. CareAcross, a digital healthcare solutions company, has initiated the 'DigiMyQoL' clinical trial (NCT07642362) to validate the effectiveness of its patient-reported outcomes (PROs)-based, personalized web platform, which allows patients to self-report side effects. This study, which began in February 2025, will collect real-world data (RWD) that is expected to significantly improve the continuity of cancer treatment by enabling healthcare professionals to accurately diagnose patients' conditions outside of the hospital setting and provide personalized guidance.
Design and Evaluation Metrics of the DigiMyQoL Clinical Trial
This study is being conducted at the Alexandra General Hospital in Athens, Greece, led by Professor Evangelos Terpos, and involves 108 adult patients. Participants are randomized into an experimental group that receives personalized educational materials and a control group that only receives confirmation of receipt. The primary endpoint is the change in the rate of 17 side effects, including fatigue, neuropathy, and bone pain, over an average of one year. Secondary endpoints include progression-free survival (PFS) and overall survival (OS) data, which will be collected to track the clinical impact of digital management on survival rates.
Unmet Needs in the Multiple Myeloma Market and Solutions
The global multiple myeloma market is rapidly growing, from $25.88 billion in 2026 to $41.39 billion in 2030. With the increasing use of expensive innovative therapies such as Daratumumab and Carvykti, the management of side effects during treatment has become a critical factor in determining treatment success. Failure to manage side effects can lead to treatment discontinuation, resulting in lost survival opportunities for patients and significant commercial losses for pharmaceutical companies. CareAcross aims to address these unmet needs by using digital tools to improve medication adherence and contribute to improved survival rates.
Differentiated Competitiveness and Business Expansion Strategy
While companies like Voluntis, with its Oleena digital therapeutic, are competing in the market, CareAcross is establishing a unique position by focusing specifically on hematological malignancies. The high-quality RWD from this clinical trial will serve as a key clinical basis for obtaining De Novo or 510(k) regulatory approval from the U.S. FDA in the future. This will not only overcome regulatory hurdles but also enable business expansion through partnerships with global pharmaceutical companies and technology licensing.
With the global multiple myeloma market rapidly growing from $25.88 billion in 2026 to $41.39 billion in 2030, CareAcross's DigiMyQoL clinical trial (NCT07642362) presents a new value-added model. In the short term, it improves medication adherence and prevents pharmaceutical companies from incurring losses due to treatment discontinuation by enabling early detection of side effects in patients treated with Daratumumab and other therapies. In the medium to long term, it secures unique real-world data (RWD) in hematological malignancies compared to competitors like Voluntis, paving the way for FDA approval and technology licensing. For researchers and clinicians, the study's data on 17 types of side effects and survival rates (PFS, OS) will demonstrate the medical validity of introducing digital companion therapies. This will facilitate the entry of digital platforms into insurance coverage and attract global pharmaceutical partnerships, driving value creation in the venture capital market.
Source: ClinicalTrials.gov (api_ct)