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    Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)

    VRd dosing and outcomes in Indian patients with Newly diagnosed Multiple Myeloma: Report from a propsepctive Clinical study

    P-323: VRd dosing and outcomes in Indian patients with Newly diagnosed Multiple Myeloma: Report from a propsepctive Clinical study

    Wednesday, September 25, 2024
    Introduction: Bortezomib lenalidomide, dexamethasone (VRd) is a highly efficacious & commonly used regimen for newly diagnosed multiple myeloma (NDMM). Delivery of such a regime requires careful attention to doses, tolerance & appropriate modification. Conflicting findings have been reported in few studies from non-caucasian patient population & there is limited data in the Indian context where tolerance is often perceived to be poor. In this analysis we evaluate prospectively the tolerance and efficacy of VRd with respect to dosing in Indian NDMM patients.

    Methods: We are enrolling NDMM patients in a prospective study evaluating the utility of MRD guided therapy (CTRI regd no: CTRI/2021/11/037702). Patients remaining MRD positive after consolidation are being randomised to maintenance versus further therapy with VRd or VPd till MRD negativity for a maximum of 1 year. The current analysis focuses on pre-randomisation therapy with VRd for patients not planned for upfront autologous stem cell transplant. Here we included patients receiving VRd for at least 8 cycles. Baseline characteristics, dose modifications & reasons for the same were collected & impact of VRd dosing on overall response rates (ORR) at end of cycle 8, MRD negativity & progression was analysed.

    Results: Total of 116 patients were included in this analysis. Ninety six had received VRd from the start of therapy while the remaining 20 (17.2%) received VCd and were changed to VRd after 1-2 cycles. Median age of the cohort is 55 (range, 32 to 75 years). R-ISS stage distribution is R-ISS 1 in 12 (10.3%), II in 57 (49.1%) & III 31 (26.7%). Starting dose reductions were done in 60 (51.7%) patients, mainly due to renal dysfunction in 26 (22.4%), age/poor performance status in10 (8.6%) patients, pre-existing neuropathy in 2 (1.7%) & cytopenias in 10 (8.6%). Sixty five (56%) required further dose reduction after starting therapy. The causes were peripheral neuropathy in 34 (29.3%), myelosuppression in 9 (7.8%), allergic skin reaction in 10 (8.6%), infections & diarrhoea in 2 (1.7%) each. Hematological adverse events were as follows: Grade 3 or more anemia & thrombocytopenia in 2 (1.7%) each & neutropenia in 3 (2.6%). In the landmark analysis of patients receiving all 8 cycles, the ORR of this cohort is higher at 92.2% and 92 (79.3%) have achieved VGPR or better. At a median follow-up of 13 months with only one death, the PFS and OS data is not mature and at 12 months time point 91% patients are progression free. The ORR, response rates VGPR or better & MRD negativity rates did not differ between patients who received reduced VRd doses versus others.

    Conclusions: Dose modifications were commonly required in our study cohort, however the majority of patients tolerated VRd with appropriate dose modifications. Dose modification did not adversely affect the myeloma outcomes at an early time point however a longer follow up is needed. This analysis suggests considering appropriate dose modification in Indian patients for optimal outcomes.