-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

1643 Retrospective Comparison of the Efficacy and Safety of Lenalidomide, Bortezomib and Dexamethasone (RVD) 21-Day Schedule Vs. 28-Day Schedule in Patients with Newly Diagnosed Multiple Myeloma

Program: Oral and Poster Abstracts
Session: 652. Multiple Myeloma and Plasma cell Dyscrasias: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Neurotoxicity, Clinical Research, Clinically Relevant, Therapies, Adverse Events, Clinical Practice (e.g. Guidelines, Health Outcomes and Services, and Survivorship, Value; etc.)
Saturday, December 11, 2021, 5:30 PM-7:30 PM

Alina Varabyeva, PharmD1*, Jens Hillengass2, Wenyan Ji, MA3*, Han Yu, PhD4*, McKenna Butler, PharmD5* and Eugene Przespolewski, PharmD6*

1Roswell Park Comprehensive Cancer Center, BUFFALO, NY
2Roswell Park Comprehensive Cancer Center, Buffalo, NY
3Department of Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY
4Department of Biostatistics & Bioinformatics, Roswell Park Cancer Institute, Buffalo, NY
5NYU Langone Hospital- Long Island, Mineola, NY
6Department of Pharmacy, Roswell Park Comprehensive Cancer Center, Buffalo, NY

Background. Based on the IFM 2009 trial, lenalidomide, bortezomib, dexamethasone (RVD) induction regimen, followed by autologous stem-cell transplantation has been the cornerstone of the treatment for newly diagnosed, transplant eligible multiple myeloma (MM) patients for many years. The treatment has been used because it allows for achievement of a deep remission in the majority of patients before stem cell collection which has been shown to be of benefit for the prognosis of patients. While this is a standard approach to induction, there are many variations in dosing. Two of the most common schedules are an RVD-21 (lenalidomide days 1-14, bortezomib days 1,4,8,11) and an RVD-28 (lenalidomide days 1-21, bortezomib weekly for three weeks). Despite the broad use of this regimen in myeloma therapy, there has been limited data that compare the efficacy and safety of these variations of RVD. This is a retrospective analysis of patients treated at a single center that compares the safety and efficacy of both schedules in newly diagnosed multiple myeloma.

Methods. Patients were assigned into two groups based on the prescribed treatment schedule: RVD-21 or RVD-28. The primary endpoint of this study is overall survival (OS). Secondary endpoints include progression-free survival (PFS) at first relapse (PFS1) and at second relapse (PFS2) and time to very good partial response (VGPR). Safety outcomes are evaluated via the incidence and severity of adverse events. OS and PFS were summarized by variables of interest using standard Kaplan-Meier methods. Multivariable Cox regression was performed to adjust for potential confounding variables. VGPR or better response rates and adverse events between two groups were compared using Fisher’s exact test.

Results. A total of 92 patients were included in the analysis, 67 patients were started on RVD-21 and 25 on RVD-28. Four patients were switched from RVD-21 to RVD-28, and 2 patients were switched from RVD-28 to RVD-21. The median OS was not reached (NR) in either group at the median follow-up time of 37.6 months. In RVD-21 group, 95% confidence interval (CI) was NR – NR and 60.1 months – NR in RVD-28 (p=0.66) (Figure 1). No difference was found in the 5-year overall survival rate between the two RVD schedules in the univariate analysis, with 0.747 (95% CI, 0.624 - 0.895) in the RVD-21 and 0.825 (95% CI, 0.683 - 0.997) in RVD-28 arm (p=0.66). Median PFS1 (C1D1 to the first progression or loss of follow-up or death from any cause) observed was 51.8 (95% CI, 39 - NR) months in patients on RVD-21 and 61.2 (95% CI, 23.7 - NR) months in patients on RVD-28 (p=0.92). Five-year PFS1 survival rate in the RVD21 group was 0.442 (95% CI, 0.316 - 0.619) and 0.545 (95% CI, 0.367 - 0.810) in RVD-28 group (p=0.92). Median PFS-2 (C1D1 to the second progression or loss of follow-up or death from any cause) observed was 125.4 (95% CI, 51.3 - NR) months in patients treated with RVD-21 and 60.1 (95% CI, 43 - NR) months in patients treated with RVD-28 (p=0.77). Five-year PFS2 survival rate in the RVD21 group was 0.609 (95% CI, 0.476 - 0.78) and 0.586 (95% CI, 0.392 - 0.877) in RVD-28 group (p=0.77). No statistically significant difference was noted in rates of achieving VGPR or better (72.1% patients in RVD-21 and 62.5% patients in RVD-28) (p=0.442). Time to VGPR analysis did not yield a statistically significant difference between the two RVD schedules (2.3 months in RVD-21 and 2.8 months in RVD-28) (p= 0.104). For each outcome, baseline variables with p<0.1 in the univariate analyses were adjusted in the Cox regression models with RVD schedule as the independent variable. No significant associations were found between RVD schedule and OS, PFS1, PFS2 or time to VGPR. These findings were consistent with the univariate analyses. No statistically significant differences in the incidence of adverse events were found in patients in either of the treatment groups. Among the patients treated with RVD-21, 23.5% reported any grade of neuropathy compared to 16.7% of patients treated with RVD-28 (p=0.575) (Table 1).

Conclusion. No differences in efficacy and safety outcomes were found among the RVD-21 and RVD-28 treatment schedules supporting individualized approach to induction schedule based on patient’s ability to tolerate therapy. Shorter therapy schedules in RVD-21 allow for faster time to transplant, however, the time to achieve VGPR was not different.


Disclosures: Hillengass: Beijing Medical Award Foundation: Speakers Bureau; Sanofi: Membership on an entity's Board of Directors or advisory committees; Skyline: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Membership on an entity's Board of Directors or advisory committees; Adaptive: Membership on an entity's Board of Directors or advisory committees; Axxess Network: Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Oncotracker: Membership on an entity's Board of Directors or advisory committees; Curio Science: Speakers Bureau; Beijing Life Oasis Public Service Center: Speakers Bureau.

*signifies non-member of ASH