Multiple MyelomaNCT06559709
A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant
A study testing Biospecimen Collection, Dietary Intervention and Medical Chart Review in people with Multiple Myeloma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Biospecimen Collection, Dietary Intervention and Medical Chart Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent prior to initiation of any study procedures
- Planned first autologous stem cell transplantation for multiple myeloma
- Planned outpatient treatment for the duration of transplantation (if admitted, the investigators will request that caregivers bring the meals/snacks to the hospital as they might with other food prepared at home)
- Access to a refrigerator
- Ability to reheat foods
- Able to consume an oral diet at enrollment
- Able to communicate clearly regarding aspects of the study: e.g. Give feedback on logistics and meals, in order to maximize the operational data the investigators can gather in this pilot study
- At least 18 years of age
Who cannot join
- Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
- Planned inpatient transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Implementing a Plant-Based Whole-Foods Meal Delivery Service for Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: A Pilot Study
This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. An autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. A plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. In this pilot study, study investigators will explore the feasibility of this approach.
Read the detailed description
OUTLINE:
Patients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample collection on study.
- Conditions
- Multiple Myeloma
- Being tested
- Biospecimen Collection, Dietary Intervention, Medical Chart Review, Questionnaire Administration
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and stool sample collection
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive 3 meals per day and snacks
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Meet with dietitian
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (meal delivery service) | Experimental | Patients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample collection on study. Receives: Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Medical Chart Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals. Reasons for non-participation will be summarized.
Measured: Up to 1 year
Collection rate
Collection rate will be the percentage of stool samples, blood samples and surveys collected.
Measured: Up to 1 month post transplant
Tolerability of the delivered diet: Patient opinion
Patient opinion of the delivered meals will be assessed using qualitative end-study surveys.
Measured: Up to 1 month post transplant
Tolerability of the delivered diet: Proportion of meals consumed
Patient acceptability of the delivered meals will be assessed using proportions of the delivered meals consumed based on multi-day food diaries and 24-hour recall assessments.
Measured: Up to 1 month post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start14 Oct 2024
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Swim Across America
- Responsible party
- Sponsor
- Investigators
- Kate Markey, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559709
- Sponsor's protocol ID
- RG1124594
- Other IDs
- NCI-2024-05448, 20501
- Status last verified
- Sep 2025
- First submitted
- 15 Jul 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ueland K, Elahi T, Rasmussen M, Wolfe AE, Purcell H, Chakka SR, Mirimo-Martinez M, Persinger H, Johnson K, Boynton AM, McMillen K, Byelykh M, Biernacki MA, Yeh AC, Ali N, Manjappa S, Wuliji N, Fredricks D, Bleakley M, Holmberg LA, Peled JU, Schenk J, Raftery D, Ma J, Hill GR, Neuhouser ML, Lee SJ, Markey KA. Plant-based whole-food diets are feasible during auto-HCT and are associated with dose-dependent microbiome modulation. Blood Adv. 2026 Jun 9:bloodadvances.2026020270. doi: 10.1182/bloodadvances.2026020270. Online ahead of print.
PubMed 42263665Ueland K, Elahi T, Rasmussen M, Wolfe AE, Purcell H, Chakka SR, Mirimo-Martinez M, Persinger H, Johnson K, Boynton A, McMillen K, Byelykh M, Biernacki MA, Yeh AC, Ali N, Manjappa S, Wuliji N, Fredricks DN, Bleakley M, Holmberg LA, Schenk JM, Raftery D, Ma J, Hill GR, Neuhouser ML, Lee SJ, Markey KA. Plant-based whole-food diets are feasible during autologous stem cell transplantation and are associated with dose-dependent microbiome modulation: Results from a pilot clinical trial. medRxiv [Preprint]. 2026 Feb 4:2026.02.02.26345403. doi: 10.64898/2026.02.02.26345403.
PubMed 41674628
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Plant-Based Whole-Foods Meal Delivery Service for Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: A Pilot Study
- ClinicalTrials.gov ID
- NCT06559709
- Acronym / sponsor ID
- RG1124594
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Swim Across America
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 19 Aug 2024 (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.
This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. An autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. A plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. In this pilot study, study investigators will explore the feasibility of this approach.
Detailed description
OUTLINE:
Patients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample collection on study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (meal delivery service) | Experimental | Procedure: Biospecimen Collection, Other: Dietary Intervention, Other: Medical Chart Review, Other: Questionnaire AdministrationPatients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample collection on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide written informed consent prior to initiation of any study procedures
- Planned first autologous stem cell transplantation for multiple myeloma
- Planned outpatient treatment for the duration of transplantation (if admitted, the investigators will request that caregivers bring the meals/snacks to the hospital as they might with other food prepared at home)
- Access to a refrigerator
- Ability to reheat foods
Key exclusion criteria (2 listed)
- Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
- Planned inpatient transplantation
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood and stool sample collection | Procedure or surgery | Supportive care (meal delivery service) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive 3 meals per day and snacks | Other | Supportive care (meal delivery service) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsMeet with dietitian | Other | Supportive care (meal delivery service) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Supportive care (meal delivery service) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (meal delivery service) |
Primary outcome
Enrollment rate
Time frame: Up to 1 year
The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals. Reasons for non-participation will be summarized.
Collection rate
Time frame: Up to 1 month post transplant
Collection rate will be the percentage of stool samples, blood samples and surveys collected.
Tolerability of the delivered diet: Patient opinion
Time frame: Up to 1 month post transplant
Patient opinion of the delivered meals will be assessed using qualitative end-study surveys.
Tolerability of the delivered diet: Proportion of meals consumed
Time frame: Up to 1 month post transplant
Patient acceptability of the delivered meals will be assessed using proportions of the delivered meals consumed based on multi-day food diaries and 24-hour recall assessments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 42263665Ueland K, Elahi T, Rasmussen M, Wolfe AE, Purcell H, Chakka SR, Mirimo-Martinez M, Persinger H, Johnson K, Boynton AM, McMillen K, Byelykh M, Biernacki MA, Yeh AC, Ali N, Manjappa S, Wuliji N, Fredricks D, Bleakley M, Holmberg LA, Peled JU, Schenk J, Raftery D, Ma J, Hill GR, Neuhouser ML, Lee SJ, Markey KA. Plant-based whole-food diets are feasible during auto-HCT and are associated with dose-dependent microbiome modulation. Blood Adv. 2026 Jun 9:bloodadvances.2026020270. doi: 10.1182/bloodadvances.2026020270. Online ahead of print.
- Derived from this study: PubMed 41674628Ueland K, Elahi T, Rasmussen M, Wolfe AE, Purcell H, Chakka SR, Mirimo-Martinez M, Persinger H, Johnson K, Boynton A, McMillen K, Byelykh M, Biernacki MA, Yeh AC, Ali N, Manjappa S, Wuliji N, Fredricks DN, Bleakley M, Holmberg LA, Schenk JM, Raftery D, Ma J, Hill GR, Neuhouser ML, Lee SJ, Markey KA. Plant-based whole-food diets are feasible during autologous stem cell transplantation and are associated with dose-dependent microbiome modulation: Results from a pilot clinical trial. medRxiv [Preprint]. 2026 Feb 4:2026.02.02.26345403. doi: 10.64898/2026.02.02.26345403.
- 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. This study is not recruiting at the moment.
Kate Markey principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Dietary Intervention and Medical Chart Review in people with Multiple Myeloma, run by Fred Hutchinson Cancer Center 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 8 Sep 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06559709, which also lists 2 linked publications.
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 8 Sep 2025.