Kidney-Tonifying, Phlegm-Resolving, and Blood Stasis-Removing Therapy for Multiple Myeloma: Protocol for a Randomized...

Area of Science:

• Integrative oncology
• Epigenetics
• Immunology

Background:

• Multiple myeloma (MM) exhibits kidney deficiency, phlegm, and blood stasis in Traditional Chinese Medicine (TCM).
• TCM's kidney-tonifying, phlegm-resolving, and blood stasis-removing (KPR) method addresses MM pathology.
• The PHF19/EZH2/H3K27me3 epigenetic axis is implicated in MM immune microenvironment dysregulation.

Purpose of the Study:

• To assess if the KPR herbal formula combined with bortezomib-based therapy improves the immune microenvironment in MM.
• To investigate the KPR formula's mechanism of action via the PHF19-EZH2-H3K27me3 epigenetic axis.
• To provide a mechanistic basis for integrating TCM into evidence-based oncology for relapsed or refractory MM.

Main Methods:

• A single-center, prospective randomized controlled trial (RCT) with 1:1:1 allocation to three groups.
• Treatment duration of 12 weeks with a 6-month follow-up.
• Primary outcome: CD3+ T-cell ratio; secondary outcomes: TCM syndrome scores, efficacy, blood counts, immunoglobulin levels, M protein, and imaging.

Main Results:

• Recruitment initiated March 2025, with 41 patients enrolled as of October 2025.
• Data collection projected to end October 2026; analysis and results expected in 2027.
• No results available yet as data analysis has not been initiated.

Conclusions:

• This RCT evaluates a TCM formula targeting the PHF19-EZH2-H3K27me3 axis in MM patients.
• It aims to establish a biomarker-driven framework for integrating TCM with immunotherapy.
• Offers potential novel strategies for treatment-refractory MM patients.