Outcomes of Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma According to Clinical Trials Enrollment: Experience of a Single Institution

Author:

Rodríguez-Lobato Luis Gerardo12ORCID,Tovar Natalia12,de Daniel Anna1ORCID,Fernández de Larrea Carlos12ORCID,Cibeira M. Teresa12,Jiménez-Segura Raquel12,Moreno David F.12ORCID,Oliver-Caldés Aina12,Bladé Joan12,Rosiñol Laura12ORCID

Affiliation:

1. Amyloidosis and Multiple Myeloma Unit, Department of Hematology, Hospital Clínic of Barcelona, Villarroel 170, 08036 Barcelona, Spain

2. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036 Barcelona, Spain

Abstract

The proportion of non-transplant-eligible (NTE) newly diagnosed multiple myeloma (NDMM) patients excluded from clinical trials (CTs) and their prognosis is unknown. CT results may not be generalizable to real-world practice due to strict recruitment criteria. We analyzed causes of NTE-NDMM patient exclusion form CTs and their outcomes. A total of 211 NTE-NDMM patients were included. They were divided into three periods: 2003–2007, 2008–2012, and 2013–2017. Overall, 50% received non-trial treatment (NCT), while 50% participated in a CT (20% control group (CG) and 30% experimental group (EG)). Main causes for exclusion from CTs were comorbidities, ECOG > 2, and renal insufficiency. In the first two periods, the CR rate was similar regardless of treatment type, but in the last period, the EG group showed improved CR. Median PFS was similar in the first two periods, with a benefit seen only in the EG in the last period. The median OS was significantly longer in CT-included patients compared to NCT group in the last two periods. Conclusions: The presence of comorbidities and worsened ECOG were the main reasons for CT exclusion. Patients included in CTs had a longer OS than NCT. This OS benefit may be influenced by a selection bias, making it challenging to generalize CT results to real clinical practice.

Funder

Instituto de Salud Carlos III

European Union

AGAUR; Generalitat de Catalunya

Asociación Española Contra el Cancer

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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