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Abstract
Clinical trials may be inconsistent in their enrollment and reporting of patients with multiple myeloma (MM) who have renal insufficiency (RI). We performed a systematic review of all MM randomized clinical trials (RCT) from 2005–2019 to evaluate reporting of prevalence, eligibility criteria and outcomes of patients with RI and MM. One-hundred and twenty-three RCTs were included. Only 30% of studies clearly reported on the proportion of patients who had RI. Only 68.2% reported eligibility criteria pertaining to RI, with no uniformity in the reported criteria. The relative risk (RR) of disease progression or death in patients with RI was higher than those without, RR of 1.20 (1.003–1.431) for relapsed/refractory and 1.07 (1.001–1.046) for newly diagnosed. There is inconsistent reporting and enrollment of patients with RI on MM RCT’s. We advocate for higher enrollment of patients with RI and transparent reporting of their eligibility criteria and outcomes.
Acknowledgments
We would like to acknowledge Professor Wade Lee-Smith for his assistance in our literature review.
Disclosure statement
The authors have no conflict of interests to disclose, other than the following for Siddhartha Ganguly (SG) and Joseph McGuirk (JM). SG: Daiichi Sankyo: Research Funding; Seattle Genetics: Speakers Bureau; Kite Pharma: Honoraria, Other: Advisory Board; Janssen: Honoraria. JM: Kite Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bellicum Pharmaceuticals: Research Funding; Astellas: Research Funding; Juno Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Fresenius Biotech: Research Funding; Gamida Cell: Research Funding; Pluristem Ltd: Research Funding; Articulate Science.