Abstract 848P
Background
Treatment including lenalidomide (LEN) as front-line therapy has become an established treatment for multiple myeloma (MM), and LEN-refractory pts have limited treatment options. Pd has demonstrated promising results in RRMM. Currently, no data is available on the efficacy of Pd in Chinese pts. We carried out a multicenter, single-arm study to further investigate the efficacy and safety of Pd in Chinese pts with RRMM.
Methods
This phase 2 study conducted between Feb 2017 and February 2019 enrolled adult RRMM pts. Pomalidomide was given orally at a dose of 4 mg once daily on days 1-21 of a 28-day cycle and continued until PD or intolerable AEs. Dexamethasone was given orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each cycle. The objective response rate (ORR) was the primary endpoint.
Results
The study enrolled 74 pts. All pts had received prior LEN, and 81% were resistant to LEN. Additionally, 51.4% pts had renal injury and 33.8% pts had high-risk RRMM. The pts were followed up for a median duration of 11.1 months (range 9.9, 12.7 months). The ORR of the full analysis set was 36.5%, and 32.0% for high-risk MM and 31.6% for MM pts with renal impairment. The median progression-free survival was 6.4 months (95%CI 3.8, 10.1). The most prevalent grade 3 and 4 treatment-emergent AEs were neutropenia (62.2%) and thrombocytopenia (28.4%). Pulmonary infections (17.6%) were the most commonly reported grade 3 and 4 nonhematologic TEAEs. No previously unreported AEs were observed, and no venous thromboembolism was reported.
Conclusions
Pd is an efficacious and safe option in Chinese pts with RRMM especially in pts refractory to LEN, with a treatment in line with the global standard.
Clinical trial identification
ChiCTR-OIC-17013234.
Editorial acknowledgement
Legal entity responsible for the study
Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ).
Funding
Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ).
Disclosure
All authors have declared no conflicts of interest.