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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

1. Willing to provide informed consent
2. Willing to comply with all study procedures and be available for the duration of the study
3. Has pathologically confirmed multiple myeloma, Non-Hodgkin lymphoma (DLBCL, mantle cell lymphoma, follicular lymphoma, or peripheral T-cell lymphoma), or Hodgkin lymphoma as determined on medical record review per standard of care transplant procedures (no tissue required for study)
4. Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
5. Adult Individuals (male or female) at least 19 years of age
6. Meeting indications and recommended for first autologous stem cell transplantation by investigator

Exclusion Criteria:

1. History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease
2. Previous intolerance to fiber supplementation
3. Allergy or intolerance to potato starch or maltodextrin
4. Subject unwilling to comply with stool sample collection
5. Not suitable for study participation due to other reasons at the discretion of the investigators

Eligibility Criteria for CAR T-cell Therapy Cohort

Inclusion Criteria:

  1. Willing to provide informed consent
  2. Willing to comply with all study procedures and be available for the duration of the study
  3. Has pathologically confirmed lymphoma or multiple myeloma meeting a commercial indication for CAR-T cell therapy
  4. Adult Individuals (male or female) at least 19 years of age
  5. Meeting indications and recommended for CAR-T cell therapy by investigator

Exclusion Criteria:

  1. History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease, or other GI surgery risking diminished effect or tolerance to therapy as determined by investigator
  2. Previous intolerance to fiber supplementation
  3. Allergy or intolerance to resistant starch or maltodextrin
  4. Subject unwilling to comply with stool sample collection
  5. Not suitable for study participation due to other reasons at the discretion of the investigators

Additional Trial Information

Enrollment: 30 patients (estimated)

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Trial Locations

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Nebraska

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

Open and Accepting
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