Clinical Research Focused on Supportive Care in Multiple Myeloma: A Cross Sectional Analysis

BACKGROUND

Outcomes of patients with multiple myeloma (MM) are improving as evidenced by prolonged overall survival (OS). Management of patients with MM includes both the treatment of malignant cells using pharmacological agents, and supportive treatment that targets the complications of the disease which include but are not limited to bone disease, renal disease, anemia, peripheral neuropathy, infections, nausea/vomiting, cachexia, quality of life , patient education and venous thromboembolism. There is a concern that supportive care related clinical research is insufficient. Our study aimed to analyze and characterize the portfolio of MM clinical research focused on supportive care.

METHODS

We analyzed all clinical research related to MM on clinicatrials.gov. Clinicaltrials.gov is the largest database of registered clinical research and include both interventional and observational research. We searched for "multiple myeloma", and "myeloma". Data cut off point was June,2022. The filter function was not used to allow for including all relevant studies. Collected data included: study identifier, title, study population (MM alone vs. MM and other malignancies), disease status (newly diagnosed, relapsed/refractory (R/R), study type (interventional vs. observational) , number of patients, location (U.S. , global), and primary aim/s. Analysis was done using R statistical software version 4.0.5 (R Project for Statistical Computing).

RESULTS

Our search resulted in 3094 research studies related to MM. 47% (n=1458) of included studies have at least one open site in the U.S. of which only 50 studies (4%, n=50/1458) were related to supportive care. The majority of analyzed studies were interventional (95%) and 51% were reported as completed. 60% of the studies were only done in R/R disease while 6% were in newly diagnosed and 34% were unspecified.

We focused our analysis on the 50 supportive research studies in the studied period. Most of supportive studies included patients with MM and other malignancies (56%, n=28/50) and only 22 supportive studies were done only in MM. in the studies that included other malignancies with MM,the majority were solid tumors. 80% of supportive studies are interventional and 44% were reported as completed. Supportive care studies were mostly related to patient education (24%), pain management (20%) bone disease related ( 16%), infection related (14%) and the rest were distributed between the following categories: quality of life, anemia, fatigue, hypercalcemia, nausea and vomiting, fatigue cachexia and venous thromboembolism.

CONCLUSIONS

There is significant lack of supportive care related clinical research in MM. With the improvement in OS, future research focus should be re-structured to develop more supportive care research focused on patients symptoms and/or other disease related complications.

Schinke:Janssen: Honoraria. van Rhee:GlaxoSmithKline: Consultancy; Karyopharm: Consultancy; Takeda: Consultancy; Janssen Pharmaceuticals: Research Funding; EUSA Pharma: Consultancy; Bristol Myers Squibb: Research Funding.