Multiple MyelomaNCT05135351
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy
A study testing Resistant Starch and Maltodextrin in people with Multiple Myeloma and Lymphoma, run by University of Nebraska at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma, Lymphoma
- What is being tested?
- Resistant Starch and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- 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)
- Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
- Adult Individuals (male or female) at least 19 years of age
- Meeting indications and recommended for first autologous stem cell transplantation by investigator
Show all 11Show fewer
- Willing to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Has pathologically confirmed lymphoma or multiple myeloma meeting a commercial indication for CAR-T cell therapy
- Adult Individuals (male or female) at least 19 years of age
- Meeting indications and recommended for CAR-T cell therapy by investigator
Who cannot join
- 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
- Previous intolerance to fiber supplementation
- Allergy or intolerance to potato starch or maltodextrin
- Subject unwilling to comply with stool sample collection
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Eligibility Criteria for CAR T-cell Therapy Cohort
Show all 11Show fewer
- 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
- Previous intolerance to fiber supplementation
- Allergy or intolerance to resistant starch or maltodextrin
- Subject unwilling to comply with stool sample collection
- Not suitable for study participation due to other reasons at the discretion of the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
Christopher R D'Angelo, MD, 402-559-8013, christopher.dangelo@unmc.edu
About this study
Official title: 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
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.
Read the detailed description
Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma, but no strategies have been identified to date that specifically target the gut microbiome. The investigators hypothesize that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment.
To test this hypothesis, the study will be a randomized, double-blind, placebo-controlled trial of resistant starch versus placebo (maltodextrin) in participants with myeloma or lymphoma undergoing autologous stem cell transplantation. Thirty subjects will be randomized 1:1 to the RS or placebo arm, dosed at 20g daily for 3 days followed by an increased to 20g twice a day mixed into a food item of the participant's choice. The intervention will begin approximately 10 days prior to stem cell infusion and will continue until the first day of neutrophil engraftment (first day absolute neutrophil count >500) or approximately 30 days in total. Fecal samples will be collected at 4 timepoints for microbiome analysis: 1) at study enrollment 2) day of stem cell infusion 3) day +7 post auto transplant and 4) first day of engraftment defined as absolute neutrophil count >500 (approximately 10-14 days post-transplant).
The primary endpoint will be the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint. Secondary endpoints will include 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.
- Conditions
- Multiple Myeloma, Lymphoma
- Being tested
- Resistant Starch, Maltodextrin
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant StarchDietary supplement
A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.
MaltodextrinDietary supplement
A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | resistant starch Receives: Dietary Supplement: Resistant Starch |
| Placebo | Placebo comparator | maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who adhere to >70% of scheduled doses of the intervention
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
Measured: 35 Days
Secondary outcomes (4)
Hospital Duration
To evaluate the duration of hospitalization according to intervention assignment by measuring time from stem cell transplant to day of discharge.
Measured: 25 days
Rate of Neutropenic Fever
To estimate the rate of neutropenic fever in the post-transplant setting according to intervention assignment. This is captured by cumulative incidence of neutropenic fever (ANC <1000, temperature >38.0⁰C) by day 30 according to intervention assignment
Measured: 25 Days
Rate of broad-spectrum antibiotic exposure
To determine the rate of broad-spectrum antibiotic exposure during transplant according to intervention assignment by measuring the proportion of subjects receiving systemic antibiotic exposure.
Measured: 25 Days
Rate of gastrointestinal symptoms
To determine the rate of gastrointestinal symptoms according to intervention assignment by using the patient-reported gastrointestinal symptom rating scale (GSRS.)
Measured: 35 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start13 May 2022
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher R D'Angelo, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135351
- Sponsor's protocol ID
- 0821-21-EP
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05135351
- Acronym / sponsor ID
- 0821-21-EP
- Conditions
- Multiple Myeloma, Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma, but no strategies have been identified to date that specifically target the gut microbiome. The investigators hypothesize that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment.
To test this hypothesis, the study will be a randomized, double-blind, placebo-controlled trial of resistant starch versus placebo (maltodextrin) in participants with myeloma or lymphoma undergoing autologous stem cell transplantation. Thirty subjects will be randomized 1:1 to the RS or placebo arm, dosed at 20g daily for 3 days followed by an increased to 20g twice a day mixed into a food item of the participant's choice. The intervention will begin approximately 10 days prior to stem cell infusion and will continue until the first day of neutrophil engraftment (first day absolute neutrophil count >500) or approximately 30 days in total. Fecal samples will be collected at 4 timepoints for microbiome analysis: 1) at study enrollment 2) day of stem cell infusion 3) day +7 post auto transplant and 4) first day of engraftment defined as absolute neutrophil count >500 (approximately 10-14 days post-transplant).
The primary endpoint will be the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint. Secondary endpoints will include 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Resistant Starchresistant starch |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrinmaltodextrin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- 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)
- Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
- Adult Individuals (male or female) at least 19 years of age
Key exclusion criteria (11 listed)
- 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
- Previous intolerance to fiber supplementation
- Allergy or intolerance to potato starch or maltodextrin
- Subject unwilling to comply with stool sample collection
- Not suitable for study participation due to other reasons at the discretion of the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant StarchA prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch. | Dietary supplement | Treatment |
| MaltodextrinA starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
Hospital Duration
Time frame: 25 days
Rate of Neutropenic Fever
Time frame: 25 Days
Rate of broad-spectrum antibiotic exposure
Time frame: 25 Days
Rate of gastrointestinal symptoms
Time frame: 35 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher R D'Angelo, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Starch and Maltodextrin in people with Multiple Myeloma and Lymphoma, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayson Henrickson, MS (402-559-3810, jayson.henrickson@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who adhere to >70% of scheduled doses of the intervention (time frame: 35 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.