Preprint Review Version 1 This version is not peer-reviewed

Impact of Daratumumab in Transplant Eligible/Ineligible Patients with Newly Diagnosed Multiple Myeloma: An Updated Meta-Analysis of Phase- III Trials

Bolivia Crocete Aloysia Fernandes
,
Vedant Shah
* ,
Muhammad Ashar Ali
,
Rahul Mehta
,
Prakash Chano Mal
,
Jannat Sardar Sheikh
,
Sulochana Gnanasekaran
,
Makarand Madine
,
Arya Alla
,
Sucharitha Pandeti
,
Jamarc Simon
,
Vinod Nookala
Version 1 : Received: 23 September 2024 / Approved: 24 September 2024 / Online: 24 September 2024 (14:01:46 CEST)

How to cite: Fernandes, B. C. A.; Shah, V.; Ali, M. A.; Mehta, R.; Mal, P. C.; Sheikh, J. S.; Gnanasekaran, S.; Madine, M.; Alla, A.; Pandeti, S.; Simon, J.; Nookala, V. Impact of Daratumumab in Transplant Eligible/Ineligible Patients with Newly Diagnosed Multiple Myeloma: An Updated Meta-Analysis of Phase- III Trials. Preprints 2024, 2024091922. https://doi.org/10.20944/preprints202409.1922.v1 Fernandes, B. C. A.; Shah, V.; Ali, M. A.; Mehta, R.; Mal, P. C.; Sheikh, J. S.; Gnanasekaran, S.; Madine, M.; Alla, A.; Pandeti, S.; Simon, J.; Nookala, V. Impact of Daratumumab in Transplant Eligible/Ineligible Patients with Newly Diagnosed Multiple Myeloma: An Updated Meta-Analysis of Phase- III Trials. Preprints 2024, 2024091922. https://doi.org/10.20944/preprints202409.1922.v1

Abstract

Background and Objectives: Daratumumab, a monoclonal antibody against CD38, has shown promising results in multiple myeloma (MM). We aimed to analyze its efficacy in newly diagnosed patients with MM. Materials and Methods: A search was conducted in PubMed, Cochrane, and Clinicaltrials.gov using the MeSH terms “daratumumab” or “Darzalex” and “multiple myeloma” covering the period until 2024. The Mantel-Haenzel formula was used to calculate the pooled risk ratio (RR), and the Generic Inverse Variance method was used to determine the pooled hazard ratio for disease progression, using RevMan version 5.4 at 95% confidence interval (CI). A P value of less than 0.05 was significant. Results: A total of 6 phase-III RCTs were analyzed. The use of daratumumab was associated with 39% fewer events of progression of disease or deaths in the TE group (RR= 0.61; 95% CI= 0.39 to 0.93; p=0.02) and 29% lower in the TIE group (RR= 0.71; 95% CI= 0.53 to 0.94; p=0.02). The hazard ratio for progression or death with daratumumab group versus control in both transplant eligible (TE) (HR= 0.44; 95% CI= 0.35 to 0.57; p<0.00001) or transplant ineligible (TIE) (HR= 0.47; 95% CI= 0.38 to 0.59; p<0.00001) group was significantly lower. Daratumumab significantly increased overall response rate (ORR) (RR= 1.20; 95% CI= 1.11 to 1.30 ; p<0.00001) and complete response (CR) (RR= 1.34; 95% CI= 1.02 to 1.76; p=0.04) in the TIE group only. Conclusions: Daratumumab showed benefits in both TE and TIE patients with newly diagnosed multiple myeloma. It significantly reduced the risk of disease progression or death and improved clinical outcomes regarding ORR and CR, suggesting an effective treatment option in these patient groups.

Keywords

daratumumab; multiple myeloma; meta-analysis

Subject

Medicine and Pharmacology, Oncology and Oncogenics

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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