“The use of high dose melphalan with AHCT is a well-established therapeutic strategy for MM. However, it’s associated with a high frequency of FN, typically around 60% of patients, despite prophylactic use of pegfilgrastim and antibiotics. This can lead to significant clinical complications resulting in extended hospitalization, readmissions and increased financial cost,” said Dr.
In this pilot study, patients with MM are treated with a single dose of melphalan and undergo AHCT. Patients receive a plinabulin 40 mg fixed dose IV infusion, and on day +1, pegfilgrastim 6 mg is administered per standard of care. The objectives of this study were to evaluate neutropenia burden, safety, tolerability, neutrophil and platelet engraftment rate, disease response, progression free survival, overall survival and patient reported outcome (PRO) assessment of symptom burden.
Poster Presentation Details
Title: Plinabulin after Autologous Hematopoietic Cell Transplant to Decrease Duration of Neutropenia and Improve Quality of Life Peri-Transplant
Abstract #: P-194
Presenter: Dr.
- 10/15 patients have been enrolled and received plinabulin on Day 0 with a median age of 64 (range 58-74) and 40% of them were female. Patients received melphalan 140 mg/m2 (n=3) or 200 mg/m2 (n=7);
- Efficacy summary:
- Median white blood count (WBC) on Day 0, 1 and 2 was 7.6 (3.6 – 9.8), 5 (3.2 – 13.6) and 18.7 (5.1-59.1) x 10^9 cells/L, respectively;
- Of the eight patients who have engrafted to date, median time to absolute neutrophil count (ANC) > 0.5 x 10^9 cells/L was 11 days (range 10-16). The median number of days of ANC <0.1 and <0.5 were two (range 1-3) and five days (range 4-9), respectively;
- Six patients had fever at median of eight days post AHCT (range 9-12). Five patients with engraftment syndrome were treated with steroids, and there was one patient with non-engraftment-related neutropenic fever (representing 10% of the patients enrolled);
- Safety Summary:
- No patients have progressed or died;
- Half of the patients had hypertension immediately after the plinabulin infusion, which is a known toxicity and resolved within a few hours;
- PROMIS-29 PRO data were collected and will be analyzed.
Dr.
About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent, which is a potent antigen presenting cell (APC) inducer that is being developed as an anticancer agent. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells and the second is a CIN prevention benefit. Plinabulin has single agent anti-cancer activity in a number of cancers including small cell lung cancer (SCLC) and multiple myeloma (MM). Plinabulin also exerts early-onset of action in the prevention of chemotherapy-induced neutropenia (CIN) by boosting the number of hematopoietic stem/progenitor cells (HSPCs).
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