Evidence map›Paper›PMID 35114691›Full record

ArticleBlood advances2022

Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials.

Bindu Kanapuru, Laura L Fernandes, Lola A Fashoyin-Aje, Andrea C Baines, Vishal Bhatnagar, Rachel Ershler, Thomas Gwise, Paul Kluetz, Richard Pazdur, Elizabeth Pulte and 2 more

Abstract read
In one paragraph

Article in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

41 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Multiple myeloma risk linked to DNA damage response genes.Journal of hematology & oncology · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Quality of Life Among Polish Patients with Multiple Myeloma: A Cross-Sectional Study.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Article
  11. Review
  12. Monoclonal Gammopathies in Africa.Clinical lymphoma, myeloma & leukemia · 2025
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Bindu KanapuruDivision of Hematologic Malignancies II.
Laura L FernandesDivision of Biometrics IX, Center for Drug Evaluation and Research.
Lola A Fashoyin-AjeDivision of Oncology III, Center for Drug Evaluation and Research and Oncology Center of Excellence.ORCID 0000-0001-7328-7813
Andrea C BainesDivision of Hematologic Malignancies II.ORCID 0000-0002-9372-415X
Vishal BhatnagarOncology Center of Excellence.
Rachel ErshlerDivision of Hematologic Malignancies II.
Thomas GwiseDivision of Biometrics IX, Center for Drug Evaluation and Research.
Paul KluetzOncology Center of Excellence.
Richard PazdurOncology Center of Excellence.
Elizabeth PulteDivision of Hematologic Malignancies I, and.
Yuan-Li ShenDivision of Biometrics V, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Nicole GormleyDivision of Hematologic Malignancies II.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

African Americans (AAs) have a higher incidence of multiple myeloma (MM) than White patients. Mortality is also higher in AAs compared with White patients. AAs more commonly have immunoglobulin H translocations t(11;14) and t(14;16) compared with White patients. We sought to characterize the demographic representation in MM clinical trials and evaluate outcomes based on race and ethnicity. We conducted a pooled analysis of all trials submitted to the US Food and Drug Administration (FDA) to support approval of a MM therapeutic between 2006 and 2019. Demographic characteristics were analyzed descriptively. An age-adjusted stratified Cox regression model was used to evaluate the relationship between time-to-event outcomes and race and ethnicity. Nineteen global trials comprising 10 157 patients were pooled. White, Asian, and Black patients comprised 84%, 7%, and 4% of the dataset, respectively; Hispanic patients comprised 4%. The age-adjusted overall survival hazard ratio (HR) for Black compared with White patients was 0.89 (95% confidence interval [CI], 0.75-1.05). The age-adjusted HR for US Black vs US White patients was 0.82 (95% CI, 0.66-1.02). For rest-of-world (RoW) Black vs RoW White patients, the HR was 1.31 (95% CI, 0.97-1.77). Black and Hispanic patients were underrepresented in the trials supporting FDA approval of MM drugs. Black patients were primarily enrolled in the United States. Outcomes in US patients were more favorable compared with those in patients in the RoW. Given the higher incidence of MM in AAs and the different disease characteristics, efforts should be made to improve representation of AAs in MM clinical trials.

Indexed as

EthnicityMultiple MyelomaBlack or African AmericanDrug ApprovalHispanic or LatinoHumansUnited States

Identifiers

PMID35114691
PMCPMC8941450

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.