Real life Standard of Care in Relapsed or Refractory Multiple Myeloma
Research type
Research Study
Full title
A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients with Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMiD, and CD38 Monoclonal Antibody Treatment
IRAS ID
266244
Contact name
Darron Green
Contact email
Sponsor organisation
Janssen Cilag Ltd
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Summary of Research
Currently we don’t have a clear picture of how heavily pre-treated patients are treated in routine clinical practice and the effectiveness of those treatments, give the lack of regulatory approved therapies in this setting.The increased use of combination therapies in multiple myeloma treatment has led to a growing number of patients with heavily pretreated myeloma (ie,patients that have been treated with bortezomib, carfilzomib, lenalidomide, pomalidomide and daratumumab and documented disease progression). In these types of patients, there is a lack of comprehensive prospective information on how they are managed in real life and what their outcomes are to subsequent treatments.
The purpose of this non-interventional study is to understand over a 24 month period the safety and clinical response of patients who have received at least 3 prior multiple myeloma treatment regimens.
Summary of Results
Study 68284528MMY4001 (LocoMMotion) was the first prospective, multinational, non-interventional study designed to evaluate effectiveness of real-life standard of care (SOC) treatments in heavily pretreated triple-class exposed participants with relapsing and/or refractory multiple myeloma (RRMM). The SOC treatments being utilized in the LocoMMotion study result in poor outcomes and often fail to prevent disease progression.
The study demonstrated and confirmed poor outcomes associated with real-life SOC treatments in a heavily pretreated triple-class exposed population. One of the key findings was the wide variety of different regimens used and absence of a well-defined SOC in this study population. The 248 participants in the LocoMMotion study were exposed to 91 unique multiple myeloma regimens during SOC treatment. After receiving SOC treatment, 152 participants were exposed to subsequent antimyeloma therapy, where the first subsequent line of therapy included 79 unique antimyeloma regimens. Overall, development and approval of antimyeloma treatments improved outcomes in RRMM patients, but eventually there was recurrence of disease. Quality of life worsened after SOC treatment and while on subsequent lines of therapy. This analysis of final data indicates an urgent need for new treatment approaches with novel therapies to achieve deep and durable responses in heavily pretreated triple-class exposed RRMM patients.
The study is completed; 248 participants were enrolled globally from August 2019 to October 2020.REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0088
Date of REC Opinion
29 Jul 2019
REC opinion
Further Information Favourable Opinion