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    Imaging, QoL and Patient-Reported Outcome and Supportive Care

    Category: Imaging, QoL and Patient-Reported Outcome and Supportive Care

    Daratumumab versus Lenalidomide Maintenance Therapy in Newly Diagnosed Multiple Myeloma – Quality of Life and Efficacy Results from a Randomized Investigator-initiated Trial

    (PA-149) Daratumumab versus Lenalidomide Maintenance Therapy in Newly Diagnosed Multiple Myeloma – Quality of Life and Efficacy Results from a Randomized Investigator-initiated Trial

    Friday, September 19, 2025
    Introduction: Lenalidomide (len) has been standard maintenance therapy in multiple myeloma (MM). Daratumumab (dara) maintenance when compared to observation has shown improved PFS. This is the first and only randomized trial (NCT04497961; n=89) that evaluated single agent dara vs len maintenance. The study is closed to accrual and final results for primary endpoint of difference in EORTC-QLQ-C30 global health status (GHS) and secondary endpoints of efficacy and toxicity will be presented.

    Methods: Pts with MM who achieve a ≥VGPR after induction were eligible. Randomization was stratified by age and ASCT status 1:1. Pts had annual bone marrow and imaging. QLQ-C30 responses were compared used a mixed effects linear regression model with random intercept. Response (median follow up 16.8 months (m) until efficacy data cutoff 10/2024) including MRD negativity by flow cytometry ( >10-5) was assessed per IMWG 2016 criteria, Kaplan–Meier approach was used to estimate PFS, and toxicities were graded per CTCAE v5.0.

    Results:

    Median age was 64, 57% male; 72% White, 25.8% had high risk cytogenetics (t(4;14), t(14;16), t(14;20), del17p, gain/amp 1q or del1p), 64% received dara during induction, 79% received ASCT.

    The mean baseline GHS for the overall study was 72 (95%CI 69, 75). There was a significant increase in GHS per cycle (mean 0.18; 95%CI 0.1, 0.26) on maintenance. There was no difference in the primary endpoint of GHS between two arms (p=0.5). The total QLQ score did not change with time on maintenance (p=0.5) and there was no difference between the arms (p=0.8).

    Improvement in social functioning (p≤0.001) and insomnia (p≤0.001) and worsening nausea/vomiting (p≤0.001), diarrhea (p≤0.001), appetite loss (p=0.03) and dyspnea (p=0.04) were noted with time on maintenance overall. When compared to dara, there was improvement in emotional functioning (p=0.01), constipation (p=0.02) and worsening in diarrhea (p≤0.001) and dyspnea (p=0.04) in the len arm.
    Best responses in len arm were 50% sCR, 11.9% CR, 35.7% VGPR and 2.4% POD and in dara arm 72.1% sCR, 11.6% CR and 16.3% VGPR. Therefore, ≥CR rates were 61.9% and 83.7% respectively. MRD negativity rates at screening and post baseline assessment were 47.6% and 53.3% in len arm and 50% and 64.5% in dara arm. PFS rates at 12m and 24m were 91% and 75.8% in len arm and 97.5% and 84.7% in dara arm. There were 13 serious adverse events in len arm and 22 in dara arm of which 42% and 32% were infections. Of 17 pts that came off study, 10 were due to POD (6 len arm; 4 dara arm).

    Conclusions: GHS improved with time on maintenance although was not different between arms. While best response, PFS and MRD negativity were numerically higher in dara arm, the study was not powered for efficacy comparison. These data add to ongoing maintenance trials utilizing anti-CD38 monoclonal antibodies. Given encouraging tolerability and efficacy, dara may be considered an effective maintenance option, especially in pts with len intolerance.