A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant

NCT06559709 | Completed

• 3 other identifiers: RG1124594NCI-2024-0544820501
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 1 year

• Collection rate

  Collection rate will be the percentage of stool samples, blood samples and surveys collected.

  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.

  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.

  Up to 1 month post transplant

Study Arms (1)

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.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Medical Chart Review; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and stool sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Supportive care (meal delivery service)

Dietary Intervention OTHER

Receive 3 meals per day and snacks

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Supportive care (meal delivery service)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Supportive care (meal delivery service)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (meal delivery service)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Swim Across America: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Specimen Handling; Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics

Study Officials

• Kate Markey

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 19, 2024
• Study Start: October 14, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)