Maintenance in myeloma patients achieving complete response after upfront therapy: a pooled analysis
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Maintenance demonstrated to improve survival in newly diagnosed multiple myeloma (NDMM) patients and the achievement of complete response (CR) is a strong predictor of survival. Nevertheless, the role of maintenance according to response after induction/consolidation has not been investigated so far. To evaluate the impact of maintenance according to response, we pooled together and retrospectively analyzed data from 955 NDMM patients enrolled in two trials (GIMEMA-MM-03-05 and RV-MM-PI-209).
Primary endpoints were progression-free survival (PFS)1, PFS2 and overall survival (OS) of CR patients randomized to maintenance and no maintenance. Secondary endpoints were PFS1, PFS2 and OS in very good partial response/partial response (VGPR/PR) patients.
Overall, 213 patients obtained CR after induction/consolidation, 118 received maintenance and 95 no maintenance. In patients achieving CR, maintenance significantly improved PFS1 (HR 0.50, P < 0.001), PFS2 (HR 0.58, P 0.02) and OS (HR 0.51, P 0.02) compared with no maintenance; the advantage was maintained across all the analyzed subgroups according to age, International Staging System (ISS) stage, cytogenetic profile and treatment. Similar features were seen in VGPR/PR patients.
Maintenance prolonged survival in CR and in VGPR/PR patients. The benefit in CR patients suggests the importance of continuing treatment in patients with chemo-sensitive disease.
The two source studies are registered at ClinicalTrials.gov: identification numbers NCT01063179 and NCT00551928.
KeywordsMultiple myeloma (MM) Maintenance therapy Newly diagnosed Complete response (CR) Prognosis
The authors thank the patients who participated in the source trials, the nurses Manuela Grasso and Luca Merlone, the data managers Jessica Mastrovito and Elena Tigano, the editorial assistants Giorgio Schirripa and Ugo Panzani.
Compliance with ethical standards
Conflict of interest
FDR has received honoraria from Celgene, BMS, and Janssen; FP has received honoraria from Celgene, Janssen, BMS; CN has served on the Advisory Board for Celgene; TC has received consultancy fees from Takeda and served on the advisory board for Jannsen, Celgene, BMS, Amgen; PM has received Honoraria from Janssen-Cilag and Celgene; PC has received honoraria from Celgene; MO has received honoraria from Celgene; AP is currently a Takeda employee; MTP has received honoraria from Celgene, Janssen-Cilag, BMS, Amgen, Takeda; MB has received research funding from Amgen, BMS, Celgene, Janssen, Mundipharma, Novartis, Sanofi; and honoraria from AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Sanofi. FG has served on the advisory board for Takeda, Seattle Genetics, Roche, Mundipharma, Janssen; and received honoraria from Takeda, Amgen, Celgene, Janssen, BMS. All the other authors have no potential conflicts of interest.
GIMEMA-MM-03-05 and RV-MM-PI-209 source studies were approved by the ethics committee of the coordinating site A.O.U. Città della Salute e della Scienza di Torino (Torino, Italy): Comitato Etico Interaziendale A.O.U. Città della Salute e della Scienza di Torino—A.O. Ordine Mauriziano—ASL Città di Torino. All procedures performed in both source studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in both source studies.
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