Immunomodulatory Effects of the Agaricus blazei Murill-Based Mushroom Extract AndoSan™ in Patients with Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Stem Cell Transplantation: A Randomized, Double-Blinded Clinical Study

Authors: Jon-Magnus Tangen, Anne Tierens, Jo Caers, Marilene Binsfeld, Ole Kristoffer Olstad, Anne-Marie Siebke Trøseid, Junbai Wang, Geir Erland Tjønnfjord, Geir Hetland

Journal: BioMed Research International

Study Design: Randomized, double-blind, placebo-controlled clinical study

Participants: 40 patients with multiple myeloma scheduled for high-dose chemotherapy and autologous stem cell transplantation

Intervention:

• AndoSan™ extract (82% Agaricus blazei, 15% Hericium erinaceus, 3% Grifola frondosa): 60 ml daily from the day of stem cell mobilization until the end of aplasia after chemotherapy (~7 weeks)
• Placebo group: Received a color-matched inert liquid

Outcome Measures:

• Changes in immune cell populations (Treg cells, dendritic cells)
• Cytokine and chemokine serum levels
• Gene expression analysis (whole genome assay for immune activation)
• Clinical outcomes: Treatment response, time in neutropenia, infection rates, overall survival, and time to new treatment

Summary:
This study investigated the immunomodulatory effects of AndoSan™ in multiple myeloma patients undergoing stem cell transplantation. Patients in the AndoSan™ group showed increased levels of IL-1ra, IL-5, and IL-7, along with higher proportions of regulatory T cells (Tregs) and plasmacytoid dendritic cells in stem cell harvests. Whole-genome microarray analysis revealed upregulation of immunoglobulin genes, Killer Immunoglobulin Receptor (KIR) genes, and HLA genes, suggesting an immunostimulatory effect.

Despite these immune changes, there were no significant differences in clinical response, overall survival, or time to new treatment between the AndoSan™ and placebo groups. The study also found a dose-dependent antiproliferative effect of AndoSan™ on myeloma cells in vitro, suggesting potential direct anti-cancer activity. No severe adverse effects were reported, indicating that AndoSan™ may be a safe adjuvant therapy, though its clinical efficacy in multiple myeloma remains uncertain.