Princess Margaret Hospital, Toronto, ON, Canada
Donna Ellen Reece , Nizar J. Bahlis , Christy Joy Samaras , Michael Sebag , Jesus G. Berdeja , Siddartha Ganguly , Jeffrey Matous , Kevin W. Song , Christopher Seet , Giampaolo Talamo , Mirelis Acosta-Rivera , Michael Bar , Donald Quick , Bertrand Marquess Anz , Gustavo A. Fonseca , Amit Agarwal , Weiyuan Chung , Faiza Zafar , David Samuel DiCapua Siegel
Background: Treatment (Tx) of RRMM is complex and requires evaluation of disease and patient (pt) factors to maximize efficacy and minimize toxicity. HRQoL has become an important aspect of MM Tx, as survival has improved with therapeutic advances. Results of the ongoing phase 2 MM-014 trial (NCT01946477) have demonstrated that pomalidomide (POM) + low-dose dexamethasone (LoDEX) + daratumumab (DARA) is safe and effective in RRMM pts after first- or second-line lenalidomide (LEN)-based Tx failure. Here we report the impact of this regimen on HRQoL. Methods: RRMM pts with 1 to 2 prior Tx lines, LEN-based Tx as their most recent regimen, and progressive disease during or after their last Tx line received POM + LoDEX + DARA in 28-day cycles (MM-014 cohort B). HRQoL, an exploratory endpoint for cohort B, was assessed via EuroQol’s EQ-5D. Results: As of October 15, 2018, 108 pts were evaluable for HRQoL. Baseline characteristics were similar to those of the ITT population (N = 112). EQ-5D completion rates for each cycle (1-6) were ≥ 88%. Mean change from baseline in the EQ-5D index and VAS health score was stable through 6 Tx cycles. At cycle 6, 28.8% and 39.0% of pts achieved minimum clinically important improvement in the EQ-5D index (≥ 0.1) and VAS health score (≥ 6), respectively. EQ-5D index values were stable, with a trend toward improvement in usual activities, pain/discomfort, and anxiety/depression (Table). Conclusions: In RRMM pts with early-line LEN Tx failure, HRQoL was maintained or trended toward improvement with POM + LoDEX + DARA, despite the combination of 3 drugs with distinct toxicities. These findings further support the earlier use of POM-based Tx in RRMM immediately after LEN failure. Clinical trial information: NCT01946477
EQ-5D From Baseline to Cycle 6, % | Mobility | Self-Care | Usual Activities | Pain/ Discomfort | Anxiety/ Depression |
---|---|---|---|---|---|
Complete resolution | 5.0 | 3.8 | 15.0 | 23.8 | 11.3 |
Partial resolution | 0 | 0 | 0 | 2.5 | 1.3 |
Stable | 83.8 | 93.8 | 71.3 | 61.3 | 81.3 |
Remain in worst state | 0 | 0 | 1.3 | 1.3 | 1.3 |
Partial deterioration | 10.0 | 1.3 | 10.0 | 7.5 | 5.0 |
Complete deterioration | 1.3 | 1.3 | 2.5 | 3.8 | 0 |
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Abstract Disclosures
2018 ASCO Annual Meeting
First Author: David Samuel DiCapua Siegel
2021 ASCO Annual Meeting
First Author: Evangelos Terpos
2017 ASCO Annual Meeting
First Author: David Siegel
2023 ASCO Annual Meeting
First Author: Sagar Lonial