University of Lille, CHU Lille, Service des Maladies du Sang, Lille, France
Thierry Facon , Shaji Kumar , Torben Plesner , Philippe Moreau , Nizar J. Bahlis , Hartmut Goldschmidt , Michael O'Dwyer , Aurore Perrot , Christopher P. Venner , Katja Weisel , Joseph R. Mace , Noopur S. Raje , Mourad Tiab , Margaret Macro , Laurent Frenzel , Xavier Leleu , Huiling Pei , Fredrik Borgsten , Saad Zafar Usmani
Background: In the phase 3 MAIA study, adding DARA to Rd improved progression-free survival (primary endpoint), overall survival, duration of response, and PROs in transplant-ineligible pts with NDMM. We report a MAIA subgroup analysis of time to response, duration of response, and PROs. Methods: Transplant-ineligible pts with NDMM received 28-day cycles of Rd (R 25 mg PO on Days 1-21; d 40 mg PO QW) ± DARA (16 mg/kg IV QW in Cycles 1-2, Q2W in Cycles 3-6, and Q4W thereafter) until disease progression or unacceptable toxicity. Secondary endpoints included time to response and duration of response. PROs were measured using the EORTC QLQ-C30, with treatment effects assessed via mixed-effects model with repeated measures. Results: In total, 368 pts were assigned to the D-Rd group and 369 pts to the Rd group; 162 (44%) D-Rd pts and 142 (38%) Rd pts had renal impairment (defined as baseline CrCl ≤60 mL/min). At a 56.2-mo median follow-up, median times to very good partial response or better (≥VGPR) and complete response or better (≥CR) were shorter with D-Rd vs Rd in the overall study population and in the subgroups of pts with and without renal impairment (Table). Among pts who achieved ≥CR or partial response or better (≥PR), higher proportions of D-Rd vs Rd pts had not experienced disease progression at 48 mo (Table). Among pts with renal impairment, greater improvements from baseline in pt-reported pain, fatigue, and nausea and vomiting symptom scores were observed with D-Rd vs Rd across most timepoints; a notably greater meaningful reduction in pain symptom score was seen with D-Rd vs Rd as early as Cycle 6 Day 1 (least squares mean change from baseline, −14.9 vs −7.0; P=0.0241). Analyses for additional pt subgroups will be presented. Conclusions: In transplant-ineligible pts with NDMM, D-Rd showed more rapid deep responses as well as more durable responses vs Rd, regardless of renal function. Improvements in pt-reported symptoms were generally greater with D-Rd vs Rd in pts with renal impairment. Our results support the use of D-Rd in transplant-ineligible pts with NDMM. Clinical trial information: NCT02252172.
All Responders (≥PR) | Responders with Baseline CrCl >60 mL/min | Responders with Baseline CrCl ≤60 mL/min | ||||
---|---|---|---|---|---|---|
D-Rd | Rd | D-Rd | Rd | D-Rd | Rd | |
Time to response | ||||||
Median (range), mo | ||||||
≥CR | 10.7 (1.0-46.7) | 13.2 (2.8-54.6) | 11.0 (1.0-41.9) | 13.0 (2.8-47.9) | 10.4 (3.0-46.7) | 13.6 (5.6-54.6) |
≥VGPR | 3.0 (0.9-55.1) | 4.7 (0.9-43.3) | 3.0 (0.9-28.9) | 4.7 (0.9-43.3) | 2.9 (0.9-55.1) | 4.9 (1.0-41.7) |
Duration of response | ||||||
Estimated 48-mo event-free rate, % (95% CI) | ||||||
≥CR | 81.8 (74.3-87.2) | 57.8 (43.4-69.7) | 82.2 (72.9-88.5) | 55.3 (37.4-70.0) | 81.0 (66.5-89.7) | 61.5 (34.8-79.9) |
≥PR | 68.7 (63.1-73.5) | 47.2 (40.8-53.3) | 69.8 (62.4-76.0) | 48.9 (40.8-56.5) | 67.2 (58.5-74.5) | 44.4 (34.1-54.3) |
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