Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS)

Abstract

Relapsed/refractory multiple myeloma (RRMM) patients have poor overall survival (OS). Pomalidomide plus low-dose dexamethasone (POM + LoDEX) significantly extends OS in RRMM vs. high-dose dexamethasone. Survival of patients with stable disease (SD) was compared to patients with progressive disease (PD) or ≥ partial response (≥PR) at cycles (C) 3, 5, and 7. Among 302 patients randomized to POM + LoDEX, at C3 19.2% achieved ≥ PR, 38.4% SD, and 14.6% PD. Patients with SD at C3 (17.4%) and C5 (13.6%) showed improved responses at C7. Median OS from randomization by response at C3 was 22.4 months for ≥ PR (n = 58, HR 0.66; 95% CI 0.40–1.08, p = 0.0976 vs. SD), 16.2 months for SD (n = 116), and 6.3 months for PD (n = 44, HR 3.43; 95% CI 2.23–5.27, p < 0.0001 vs. SD). Similar patterns were observed for C5 and C7. Results show that POM + LoDEX should be a standard treatment after lenalidomide and bortezomib, including in SD patients.

Keywords:

• MM-003
• multiple myeloma
• pomalidomide

Acknowledgements

We thank the patients who participated in this study, the staff members at the study sites who cared for them, and the representatives of the sponsors who were involved in data gathering and analyses. We also thank BresMed for providing the statistical analysis, and Dr Vanessa Gray-Schopfer, OmniScience SA, for providing medical writing services funded by Celgene.

Potential conflict of interest

The authors are fully responsible for content and editorial decisions for this manuscript. The authors made substantial contributions to the concept and design of the manuscript; they participated in collection, data analysis, interpretation, and assembly of the data. All the authors revised the article critically for important intellectual content and have given final approval of the version of the manuscript for submission. Disclosure forms provided by the authors are available with the full text of this article at http://dx.doi.org/10.1080/10428194.2016.1180685.

Funding information

Celgene Corporation provided funding for the analysis and for medical writing. Celgene did not collect nor analyze the data.