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Updated: Mar 22, 2026
An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells
Published on: July 15, 2015
Differences between unselected patients and participants in multiple myeloma clinical trials in US: a threat to
Luciano J Costa1, Parameswaran N Hari2, Shaji K Kumar3
1a Division of Hematology and Oncology , University of Alabama at Birmingham , Birmingham , AL , USA.
Abstract:
External validity of clinical trials is affected by dissimilarities between study subjects and patient population. We identified 128 manuscripts (8,869 subjects) published between 2007 and 2014 reporting results of multiple myeloma (MM) trials performed entirely in the US. Characteristics of subjects were compared with unselected patients from SEER-18. Median of median age of subjects was 61 years vs. median age of unselected patients of 69 years. Trial subjects with untreated MM had less advanced stage than unselected patients. Racial-ethnic composition was informed in only 51 (39.8%) trials. Industry-sponsored trials were more likely to report accrual of minorities than National Cancer Institute (NCI) or investigator-sponsored trials. The observed/expected minority accrual was 0.52 (95% CI 0.49-0.55), being lower (0.43) in investigator-sponsored and higher (0.61) in industry-sponsored trials. We concluded that minorities, older individuals and persons with more advanced disease are underrepresented in MM trials, potentially compromising external validity of results.
Insights
Clinical trials for multiple myeloma (MM) underrepresent minorities, older adults, and advanced disease patients. This disparity may limit the generalizability of trial findings to the broader patient population.
Area of Science:
- Clinical Oncology
- Health Services Research
Background:
- External validity of clinical trials is crucial for generalizability.
- Dissimilarities between clinical trial participants and the general patient population can compromise external validity.
- Multiple myeloma (MM) clinical trials are a key area for evaluating treatment efficacy.
Purpose of the Study:
- To assess the representativeness of participants in US-based multiple myeloma clinical trials.
- To compare the characteristics of MM trial subjects with the general MM patient population.
- To identify potential disparities in age, disease stage, and racial-ethnic composition within MM trials.
Main Methods:
- Systematic review of 128 manuscripts reporting MM trials conducted in the US between 2007 and 2014.
- Comparison of trial subject demographics with data from the SEER-18 registry for unselected MM patients.
- Analysis of racial-ethnic composition reporting and accrual rates across different trial sponsorship types (industry, NCI, investigator-sponsored).
Main Results:
- MM trial subjects were younger (median age 61) than the general MM population (median age 69).
- Trial participants with untreated MM had less advanced disease compared to unselected patients.
- Minority accrual in MM trials was lower than expected (observed/expected ratio 0.52), particularly in investigator-sponsored trials.
Conclusions:
- Multiple myeloma clinical trials exhibit underrepresentation of older individuals, minorities, and patients with more advanced disease.
- These demographic and clinical disparities may limit the external validity and applicability of MM trial findings.
- Improved trial design and recruitment strategies are needed to enhance the representativeness of MM clinical trials.
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