Protocol for an International, Multi-Centre, Retrospective Study to Describe Treatment Pathways, Outcomes and Resource Use in Patients with Multiple Myeloma (INTEGRATE)
Authors: Yeh Su-Peng , Alsharif Fahad , Beksac Meral , Chen Wenming , Fantl Dorotea , Mitina Tatiana , Verburgh Estelle , Chng Wee Joo , Wu Kwang-Wei , Zhang Zijing , Wan Hui , Kim Kihyun 
Published: November 2019

Introduction

The incidence of multiple myeloma (MM) has increased globally in the past decade and is predicted to increase in developing countries due to ageing populations and improvements in diagnosis. Studies outlining the relationship between long-term patient outcomes and treatment strategies remain limited. As a result, there is a need for data on treatment effectiveness with long-term patient outcomes such as time to next treatment and overall survival, as well as toxicity, and healthcare resource utilization in developing countries. The real-world INTEGRATE study seeks to address this gap by providing data on long-term outcomes, and management strategies in developing countries.

Methods

The INTEGRATE study (ENCePP registration number: EUPAS21846) is a global, multi-centre, retrospective, observational study ongoing in 8 countries representing different clinical settings (Argentina, China, Russia, South Africa, South Korea, Taiwan, Turkey, Saudi Arabia). This study is collecting data from patients with newly diagnosed MM (NDMM) or with relapsed/refractory MM (RRMM), by means of a retrospective review of electronic or paper medical records.

Patients aged ≥18 years who are alive or deceased, diagnosed with symptomatic NDMM and/or RRMM between 01 January 2010 and 31 December 2011, and who completed ≥1 full line of treatment have been included in the study. Patients with smouldering myeloma, monoclonal gammopathy of unknown significance, without enough data, or enrolled in a clinical trial have been excluded.

Study design is summarized in the figure. The primary endpoint is time to next treatment after each line of therapy for both the NDMM and RRMM populations. Secondary endpoints include reporting patient demographic and clinical characteristics, treatment patterns, and clinical outcomes (relapse rate, overall survival rate, number of relapses for each line of therapy).

The sample size (N=2000) has been determined based on local feasibility and incidence within each country. A sample of at least 50 patients should provide reliable estimates of the primary endpoint at country level. Subgroup analyses will be performed to describe the outcomes associated with different treatment regimens, including autologous and non-autologous stem cell transplant.

Results

The study is expected to enrol 2000 patients in all countries by December 2019. As of 09 July 2019, a total of 1731 patients have been enrolled with most patients enrolled in Taiwan, Turkey, Russia and South Korea. Once complete, the results will be reported at future scientific meetings.

Conclusion

This large study based on a diverse population of patients will provide a unique data set with long-term patient outcomes in MM in developing countries. Ultimately, this real-world information regarding treatment effectiveness, toxicity, and resource use in developing countries will support decision making for both clinicians and payers.

Figure

Disclosures

Alsharif: Algoryth: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Beksac:Takeda: Consultancy; Janssen&Janssen: Consultancy; Amgen: Consultancy; Celgene: Consultancy. Verburgh:Roche: Research Funding; Takeda: Research Funding. Wu:Takeda: Employment. Zhang:Takeda: Employment. Wan:Takeda: Employment.