Prebiotics to Improve Gut Microbiome Diversity after Stem Cell Transplantation in Patients with Multiple Myeloma and Lymphoma, The PRIMAL Trial

PRIMARY OBJECTIVES:

I. To understand the feasibility of the intervention in the proposed study population.

II. To explore the impact of a prebiotic intervention on gut microbiome diversity post-transplant.

III. To determine the difference in composite quantitative abundance of Faecalibacterium prausnitzii, Ruminococcus species, and Akkermansia Mucinophila. (Chimeric antigen receptor [CAR] t cell cohort)

SECONDARY OBJECTIVES:

I. To evaluate the duration of hospitalization according to intervention assignment.

II. To evaluate the impact of dose intensity of resistant starch on gut microbiota composition.

III. To estimate the rate of neutropenic fever in the post-transplant setting according to intervention assignment.

IV. To determine the rate of broad-spectrum antibiotic exposure during transplant according to intervention assignment.

V. To determine the rate of gastrointestinal symptoms according to intervention assignment.

VI. To explore the impact of a prebiotic intervention on gut microbiome diversity post-CAR T-cell infusion. (CAR T cell cohort)

VII. To determine the rate of broad-spectrum antibiotic exposure during CAR T-cell therapy according to intervention assignment. (CAR T cell cohort)

VIII. To determine the rate of gastrointestinal symptoms according to intervention assignment. (CAR T cell cohort)

IX. To evaluate the feasibility of the prebiotic regimen. (CAR T cell cohort)

CORRELATIVE/EXPLORATORY OBJECTIVES:

I. To determine the feasibility of using the ASA24 dietary survey in subjects undergoing stem cell transplantation.

II. To investigate the dietary intake in subjects undergoing stem cell transplantation.

III. To investigate the change to gut microbiota according to pre-transplant dietary intake.

IV. To investigate the impact of polyphenol intake on gut microbiota composition and transplant toxicity.

V. To evaluate markers of gut permeability in the peripheral blood.

VI. To assess changes to gut microbiome sub-populations following the prebiotic intervention, namely the effect of prebiotics on butyrate-producing species including bifidobacteria, lactobacilli species, Eubacterium species, and clostridial species.

VII. To evaluate markers of gut permeability in the peripheral blood. (CAR T cell cohort)

VIII. To evaluate impact of prebiotic intervention on circulating t-lymphocyte populations. (CAR T cell cohort)

IX. To evaluate the relationship between the gut microbiome and circulating T-cell populations. (CAR T cell cohort)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive resistant starch orally (PO) once daily (QD) for 3 days and then twice daily (BID) for up to 26-30 days.

ARM B: Patients receive maltodextrin PO QD for 3 days and then BID for up to 26-30 days.