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Age demographics of subjects enrolled in interventional phase 3 multiple myeloma clinical trials

Abhilasha Borad1,2, Hamnah Saeed1, Michael Toscani1

  • 1Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, NJ, USA.

Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners
|July 3, 2020
PubMed

Insights

Phase 3 clinical trials for multiple myeloma often enroll younger patients than the disease

Area of Science:

  • Hematology
  • Clinical Trials Research
  • Geriatric Medicine

Background:

  • Multiple myeloma diagnosis typically occurs in older adults, with a mean and median age of 70-73 years.
  • Over 63% of multiple myeloma patients are diagnosed over the age of 65.
  • Phase 3 clinical trials aim to represent the target disease population for accurate efficacy studies.

Purpose of the Study:

  • To analyze the age demographics of participants in interventional phase 3 clinical trials for multiple myeloma.
  • To assess whether these clinical trials adequately represent the actual age distribution of multiple myeloma patients.

Main Methods:

  • A systematic search of interventional phase 3 multiple myeloma clinical trials with reported results was conducted on clinicaltrials.gov.
  • Mean and median ages of study subjects were extracted and averaged from 81 assessed trials.
  • Calculated average mean age was 65.78 years; calculated average median age was 63.29 years.

Main Results:

  • Phase 3 clinical trials for multiple myeloma enrolled patients younger than the disease's typical age demographic.
  • The average mean age of participants was 65.78 years, and the average median age was 63.29 years.
  • This indicates a potential underrepresentation of older adults in multiple myeloma research.

Conclusions:

  • Current phase 3 clinical trials may not fully represent the older patient population with multiple myeloma.
  • There is a significant unmet need for research focusing on older adults with multiple myeloma.
  • This gap may limit the generalizability and clinical utility of findings from current multiple myeloma trials.
Keywords:
Multiple myelomaage demographicsclinical trial designgeriatric oncologytrial participants

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