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