NCT05135351

A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy in Multiple Myeloma and Lymphoma: The PRIMAL Trial

Recruiting now NA Last updated 14 April 2026

What this trial tests

NA trial testing Resistant Starch in Multiple Myeloma in 30 participants. Currently enrolling.

Timeline

7 June 2022

Primary endpoint
1 July 2028

1 July 2028

Quick facts

Lead sponsor	University of Nebraska
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	30
Start date	7 June 2022
Primary completion	1 July 2028
Estimated completion	1 July 2028
Sites	1 location across United States

Drugs / interventions tested

• Resistant Starch
• Maltodextrin (MALTODEXTRIN) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →
• Lymphoma — all drugs for Lymphoma →

Sponsor

University of Nebraska

Who can join

19 and older, any sex, with Multiple Myeloma or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of subjects who adhere to >70% of scheduled doses of the intervention
  Time frame: 35 Days
  To understand the feasibility of the intervention in the proposed study population, the percentage of subjects who adhere to \>70% of scheduled doses will be calculated

Sponsor's own description

Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment. To test this, participants will either have RS or a placebo (maltodextrin) mixed into a food item of their choice for approximately 10 days prior to stem cell infusion and continue to the first day of neutrophil engraftment. The study will look at the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint, dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dietary and microbiome evidence in multiple myeloma and other plasma cell disorders.
   Shah UA, Parikh R, Castro F, Bellone M, et al · · 2023 · cited 28× · PMID 36997677 · DOI 10.1038/s41375-023-01874-4
2. Nutritional modulation of the gut microbiome in allogeneic hematopoietic stem cell transplantation recipients.
   Muratore E, Leardini D, Baccelli F, Venturelli F, et al · · 2022 · cited 27× · PMID 36337625 · DOI 10.3389/fnut.2022.993668
3. The Insider: Impact of the Gut Microbiota on Cancer Immunity and Response to Therapies in Multiple Myeloma.
   Brevi A, Cogrossi LL, Lorenzoni M, Mattorre B, et al · · 2022 · cited 18× · PMID 35371048 · DOI 10.3389/fimmu.2022.845422
4. Defining the Role of the Gut Microbiome in the Pathogenesis and Treatment of Lymphoid Malignancies.
   Upadhyay Banskota S, Skupa SA, El-Gamal D, D'Angelo CR. · · 2023 · cited 14× · PMID 36768631 · DOI 10.3390/ijms24032309
5. Pharmacomicrobiomics in Anticancer Therapies: Why the Gut Microbiota Should Be Pointed Out.
   Conti G, D'Amico F, Fabbrini M, Brigidi P, et al · · 2022 · cited 13× · PMID 36672796 · DOI 10.3390/genes14010055
6. Diet-driven microbiome changes and physical activity in cancer patients.
   Ciernikova S, Sevcikova A, Stevurkova V, Mego M. · · 2023 · cited 11× · PMID 38075222 · DOI 10.3389/fnut.2023.1285516
7. Gut Microbiota Dysbiosis and Dietary Interventions in Non-Hodgkin B-Cell Lymphomas: Implications for Treatment Response.
   Caserta S, Alvaro ME, Penna G, Fazio M, et al · · 2025 · cited 1× · PMID 41007706 · DOI 10.3390/biomedicines13092141
8. Duration of Hospitalization is Associated with the Gut Microbiome in Patients Undergoing Hematopoietic Stem Cell Transplantation: Early Results from a Randomized Trial of Home Versus Hospital Transplantation.
   Andermann TM, Zeng K, Guirales-Medrano S, Groth A, et al · · 2025 · PMID 41114048 · DOI 10.21926/obm.transplant.2503255