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

NCT ID: NCT06559709

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2025-08-29

Brief Summary

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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

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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

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (meal delivery service)

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and stool sample collection

Dietary Intervention

Intervention Type OTHER

Receive 3 meals per day and snacks

Dietary Intervention

Intervention Type OTHER

Meet with dietitian

Medical Chart Review

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo blood and stool sample collection

Intervention Type PROCEDURE

Dietary Intervention

Receive 3 meals per day and snacks

Intervention Type OTHER

Dietary Intervention

Meet with dietitian

Intervention Type OTHER

Medical Chart Review

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions Chart Review

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swim Across America

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kate Markey

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2024-05448

Identifier Type: REGISTRY

Identifier Source: secondary_id

20501

Identifier Type: OTHER

Identifier Source: secondary_id

RG1124594

Identifier Type: -

Identifier Source: org_study_id

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