Page 213 - Haematologica Vol. 109 - July 2024

ARTICLE - S-DVd in RRMM patients
V. González-Calle et al.
manage treatment related AE.
Our study has several limitations. First, it is a phase II non-randomized trial, with a limited number of patients, and, some of the prior comparisons are limited by different confounders such as differences in study design, methods, or patient’s characteristics. Indeed, the weekly bortezomib schedule may explain the lower incidence of peripheral neuropathy seen in the GEM-Selibordara trial (21%, grade 3-4: 0%) as compared to the CASTOR trial (50%, grade 3-4: 4.5%).11 Regarding selinexor dosing, in the part 2 the schedule and dose was adjusted (60 mg every week in a 5-week cycle) to improve tolerability. As a result, there were fewer discontinuations as compared to part 1, suggesting that 60 mg weekly of selinexor might be the optimal dose for the combination with DVd in a well balanced manner between efficacy and toxicity.26
In summary, encouraging efficacy and generally manage- able safety were observed in this phase II multicenter trial evaluating S-DVd in RRMM patients, including in patients who were len-refractory, suggesting this combination could be an attractive option for len-refractory but daratumum- ab-sensitive patients if cardiovascular comorbidities are a concern or oral formulations are preferred.
Disclosures
VG-C discloses consulting for or advisory role at Janssen; speakers’ bureau at Janssen, GlaxoSmithKline, Pfizer, Bris- tol Myers Squibb/Celgene, travel and accommodation ex- penses from Janssen and GlaxoSmithKline. PR-O discloses honoraria derived from consulting or advisory board role at Celgene-BMS, Janssen, Roche, Abbvie, Pfizer, GSK, Sanofi and H3Biomedicine; steering committee membership at Celgene-BMS, Regeneron and Janssen; speaker’s bureau at Janssen, Celgene-BMS, GSK, Sanofi and Abbvie; travel grant from Pfizer. FA discloses honoraria for lectures and advisory board from Janssen, BMS-Celgene, Amgen, GSK, Sanofi and Takeda. AO discloses honoraria from consultant activities for Amgen, Celgene, BMS, GSK, Janssen and Sanofi. JM-L discloses honoraria from consulting activities for Astellas Pharma, BMS, F.Hoffman-La Roche, Janssen, Novartis and Sanofi; research grant from BMS. MVM discloses honoraria derived from lectures and advisory role at Amgen, Celgene, BMS, GSK, Janssen, Pfizer, Regeneron, Sanofi and Takeda. M-TH discloses consulting or advisory role at Janssen, Sanofi/ Aventis, Celgene/Bristol Myers Squibb and GlaxoSmithKline; speakers’ bureau at Janssen, Celgene/Bristol Myers Squibb
References
1. Puertas B, González-Calle V, Sobejano-Fuertes E, et al. Novel agents as main drivers for continued improvement in survival in multiple myeloma. Cancers (Basel). 2023;15(5):1558.
2. Vogl DT, Dingli D, Cornell RF, et al. Selective inhibition of nuclear export with oral selinexor for treatment of relapsed or refractory multiple myeloma. J Clin Oncol. 2018;36(9):859-866.
and GlaxoSmithKline; research funding from Celgene/Bristol Myers Squibb (Inst). M-TC discloses honoraria from Jans- sen. NP discloses honoraria from Amgen, Celgene, Janssen, Takeda and The Binding Site; consulting or advisory role at Amgen, Celgene, Janssen and Takeda; speakers’ bu- reau of Celgene; research funding from Celgene, Janssen, Amgen and Takeda; travel and accommodation expenses from Amgen, Celgene, Janssen and Takeda. BP discloses honoraria for lectures and advisory boards from Adaptive, Amgen, BMS-Celgene, Gilead, GSK, Janssen, Oncopeptides, Roche, Sanofi and Takeda; unrestricted grants from Bei- gene, BMS-Celgene, EngMab, GSK, Roche, Sanofi and Take- da; consultancy for BMS-Celgene, Janssen and Sanofi. JB discloses honoraria for lectures and advisory boards from Janssen, BMS-Celgene, Amgen, Takeda and Oncopeptides. JJL discloses consulting or advisory role at Celgene, Am- gen, Janssen-Cilag and Sanofi; travel and accommodation expenses from Celgene and Pfizer. JSM discloses consulting activies at Abbvie, Amgen, BMS, Celgene, F.Hoffman-La Roche, GSK, HaemaLogiX, KaryoPharm, Merck, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Takeda and SecuraBio. MVM discloses honoraria for lectures and advisory boards from Janssen, Celgene, Takeda, Amgen, GSK, Abbvie, Pfizer, Regeneron, Roche, Sanofi and Oncopeptides. The remaining authors have no conflicts of interest to disclose.
Contributions
MVM and JSM designed the study and wrote the protocol. VG-C and PR-O made the statistical analysis and wrote the manuscript. All authors contributed to enrolling patients in the clinical trial and provided data. All author reviewed and approved the manuscript.
Data-sharing statement
The Spanish Myeloma Group is open to the possibility of sharing the data used in this study for research projects as long as they do not interfere with the present or future objectives of the clinical trial. The interest and feasibility of any clinical or biological research proposal based on the data from this study must be approved by the board of directors of the Spanish Myeloma Group. In such a case, the data, deposited in REDCap, will be presented in anonymized CSV format. This availability is subject to the laws and provisions in force that regulate the development of clinical trials both in Spain and in the European Union. Data are available on request from the corresponding author.
3. Syed YY. Selinexor: first global approval. Drugs 2019;79(13):1485-1494.
4. Chen C, Siegel D, Gutierrez M, et al. Safety and efficacy of selinexor in relapsed or refractory multiple myeloma and Waldenstrom macroglobulinemia. Blood. 2018;131(8):855-863.
5. Chari A, Vogl DT, Gavriatopoulou M, et al. Oral selinexor-
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