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Event Title
FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials
February 13, 2020


Date:
February 13, 2020
Time:
8:00 AM - 5:00 PM ET

#MyelomaDiversity

Co-Sponsored by the: U.S. Food & Drug Administration (FDA) and The American Association for Cancer Research (AACR)

Workshop Co-Chairs:

  • Kenneth C. Anderson, MD – Dana Farber Cancer Institute/Harvard Medical School
  • Lola A. Fashoyin-Aje, MD, MPH - U.S. FDA
  • Nicole Gormley, MD - U.S. FDA
  • Paul G. Kluetz, MD – U.S. FDA

Location

Washington Marriott Wardman Park
2660 Woodley Road, Northwest
Thurgood Marshall Ballroom
Washington, DC 20008
(202) 328-2000

Registration:

If you wish to attend the public workshop, please register at the following link

Background: 

African Americans or blacks are disproportionately affected by multiple myeloma. Blacks have a 2-3 fold higher incidence of multiple myeloma compared to whites and represent 30% of the multiple myeloma patients in the U.S. (Waxman, Mink et al. 2010, Ailawadhi, Jacobus et al. 2018). Additionally, studies have shown differences in survival between whites and blacks, with black individuals having lower relative survival rates (Costa, Brill et al. 2017), and a higher incidence of certain genetic subtypes of myeloma (e.g., t(11;14), t(14;16), or t(14;20) cytogenetic subtypes) among patients with high African ancestry compared to patients with low African ancestry (Baughn, Pearce et al. 2018).  

Despite having higher incidence of myeloma, lower survival rates, and differences in the cytogenetic profile of the disease, blacks have historically been underrepresented in clinical trials. A recent review conducted by the FDA evaluated the racial demographics of individuals enrolled on trials submitted in the marketing applications of drugs intended to treat multiple myeloma between 2003 and 2017 (Bhatnagar 2017). Notably, 4.5% of patients enrolled in these trials were black.  

Workshop Goals and Objectives

  1. Discuss the genetics and biology underlying racial and ethnic differences in multiple myeloma.
  2. Characterize enrollment characteristics and outcomes of black patients in multiple myeloma registration trials and real-world data sources.
  3. Discuss the limitations of currently available data in racial and ethnic minorities with multiple myeloma.
  4. Obtain input from multiple stakeholders on approaches to increase our knowledge of the safety and efficacy of anti-myeloma therapeutics in racial and ethnic minorities.

Webcast Information:

A free-of-charge webcast of this workshop will be provided for those unable to attend in person. Registration for the webcast is required.  

FDA and AACR plans to post archived webcasts after the meeting, however, in cases where the transmission was not successful, archived webcasts will not be available. The link for the webcast will be provided to all registered no less than 24 hours prior to the start of the workshop. 

Workshop Information: (documents will be added when available)

  • Agenda
  • Participant List – coming soon
  • Speaker biographies – coming soon 

Contacts:

AACR: Sarah Martin, MS, PhD
Director, Regulatory Science and Policy
Office of Science Policy and Government Affairs
American Association for Cancer Research
Email: sarah.martin@aacr.org
Phone: 267-765-1029 

FDA: Sonia C. Swayze
Regulatory Health Project Manager/Oncology Program
Oncology Center of Excellence (OCE) / FDA
Email: sonia.swayze@fda.hhs.gov
Phone: 301-796-6132

Angela James
Regulatory Health Project Manager/Oncology Program
Oncology Center of Excellence (OCE) / FDA
Email: Angela.james@fda.hhs.gov
Phone: 301-796-6122

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