Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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This trial investigates the effect of fermented milk supplementation on symptoms of disease and treatment in patients with multiple myeloma. Patients with multiple myeloma may experience symptoms related to the disease and/or treatment that affect quality of life. Supplementing usual diet with a probiotic fermented milk product called kefir may contribute to reducing disease and treatment-related side effects through changing the intestinal bacteria community structure and related metabolism.

Detailed Description
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PRIMARY OBJECTIVE: I. Determine the effect of a 3-month randomized dietary intervention with a probiotic kefir beverage in multiple myeloma (MM) patients on biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and quality of life (QoL). SECONDARY OBJECTIVE: I. Determine the effect of kefir supplementation on gut microbial phylotype and predicted bacterial metabolic function, and assess associations with biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and QoL. EXPLORATORY OBJECTIVE: I. Feasibility of a probiotic lifestyle intervention in MM patients. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients consume commercial kefir beverage daily for 3 months. ARM II: Patients maintain usual diet for 3 months. After completion of study, patients are followed up at 30 days or until resolution of any study related toxicity.

Official Title
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Pilot Study of Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma

Conditions
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Plasma Cell Myeloma

Intervention / Treatment
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* Other: Best Practice
* Dietary Supplement: Kefir
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Neutrophil values > 1,000/uL Diagnosis of multiple myeloma: on maintenance or continued treatment Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion Able to understand and comply with study instructions, including willing to purchase and consume study beverage daily if in intervention arm or, avoid regular consumption of fermented dairy foods (kefir, yogurt, lassi, etc.) if in the control arm Understand the investigational nature of the study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Allergies to milk Lactose intolerance Current habitual (> 3 times per week) consumption of yogurt, kefir, lassi, over-the-counter probiotic dietary supplements Chronic inflammatory bowel disease Autologous stem cell transplantation or chimeric antigen receptor (CAR)-T cell therapy within the last 6 months Prior allogeneic stem cell transplantation Major comorbidities that would cause danger to the patient when participating in the study Pregnant or nursing female participants Unwilling or unable to follow protocol requirements Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (commercial kefir beverage)<br>Patients consume commercial kefir beverage daily for 3 months. | Dietary Supplement: Kefir<br>* Consume commercial kefir beverage<br>* Other names: Kephir;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (usual diet)<br>Patients maintain usual diet for 3 months. | Other: Best Practice<br>* Maintain usual diet<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of parathyroid hormone (PTH) | Collect Changes in values of PTH from baseline to week 12in patients who added kefir to their diet | Week 12 | 
| Change in quality of life | Will be assessed by European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life-Core 30 and EORTC Myeloma module. Will compare the changes in outcomes pre- to post-intervention between groups using an ANCOVA model | Up to 30 days post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Gut microbial community structure | Will evaluate changes in microbial community structure, measured as a beta diversity metric. These changes will be assessed using a regression based kernel association test. Unrarefied phyla, genera, species, and imputed functional genes in pathways will be center log ratio transformed to better approximate a normal distribution. Linear mixed models adjusting for sex, age, body fat mass, energy intake, and baseline measures will be used to evaluate differences in response between diets for alpha diversity, individual phyla, genera, species, and imputed functional gene pathways. | At baseline and after 3 months daily kefir consumption |