A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the GeminiS study

ABSTRACT

Objectives:

To describe the incorporation of monoclonal antibodies (mAb) in real-world (RW) practice for the treatment of patients with relapsed refractory multiple myeloma (RRMM) in a setting with other treatment alternatives.

Methods:

This was an observational, multicenter, ambispective study of RRMM treated with or without a mAb.

Results:

A total of 171 patients were included. For the group treated without mAb, the median (95% CI) progression-free survival (PFS) to relapse was 22.4 (17.8-27.0) months; partial response or better (≥PR) and complete response or better (≥CR) was observed in 74.1% and 24.1% of patients, respectively; and median time to first response in first relapse was 2.0 months and in second relapse was 2.5 months. For the group of patients treated with mAb in first or second relapse, the median PFS was 20.9 (95% CI, could not be evaluated) months; the ≥ PR and ≥ CR rates were 76,2% and 28.6%, respectively; and the median time to first response in first relapse was 1.2 month and in second relapse was 1.0 months. The safety profiles for the combinations were consistent with those expected.

Conclusions:

The incorporation of mAb in RW practice for the treatment of RRMM has shown good quality and speed of response with a similar safety profile shown in randomized clinical trials.

KEYWORDS:

• Relapsed-refractory multiple myeloma
• real-world
• monoclonal antibodies
• daratumumab
• standard of care

Acknowledgements

The authors would like to thank to all the patients and their families who participated in this study, the staff members at the study sites who cared for them and all the researchers of the GeminiS study group. The authors also thank Andrea Barchino and Susana Vara (APICES, Madrid; Spain) for their support with the study setup, coordination and project management, monitoring, and statistical analysis and Fernando Rico-Villademoros (APICES, Madrid, Spain) for writing a draft of this manuscript.

Data availability statement

Data is available from corresponding author upon reasonable request. The data will be provided after its deidentification in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This study was sponsored by Janssen-Cilag. Janssen-Cilag participated in the study design, data analysis and drafting of the manuscript. All investigators received financial compensation for their participation in the study.