Plasma Cell MyelomaNCT04530812
Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma
A study testing Best Practice, Kefir and Quality-of-Life Assessment in people with Plasma Cell Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Best Practice, Kefir and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 30 Aug 2021
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Pilot Study of 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Best Practice, Kefir, Quality-of-Life Assessment, 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.
Best PracticeOther
Also called standard of care, standard therapy
Maintain usual diet
KefirDietary supplement
Also called Kephir
Consume commercial kefir beverage
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (commercial kefir beverage) | Experimental | Patients consume commercial kefir beverage daily for 3 months. Receives: Dietary Supplement: Kefir; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (usual diet) | Active comparator | Patients maintain usual diet for 3 months. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 30 days post-intervention
Secondary outcomes (1)
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.
Measured: At baseline and after 3 months daily kefir consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start24 Aug 2020
- Primary completion27 Jul 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Hillengass, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530812
- Sponsor's protocol ID
- I 657720
- Other IDs
- NCI-2020-05777, I 657720
- Status last verified
- Nov 2021
- First submitted
- 21 Aug 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04530812
- Acronym / sponsor ID
- I 657720
- Conditions
- Plasma Cell Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 28 Aug 2020 (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 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
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (commercial kefir beverage) | Experimental | Dietary Supplement: Kefir, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients consume commercial kefir beverage daily for 3 months. |
| Arm II (usual diet) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients maintain usual diet for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyMaintain usual diet | Other | Arm II (usual diet) |
| KefirAlso: KephirConsume commercial kefir beverage | Dietary supplement | Arm I (commercial kefir beverage) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (commercial kefir beverage), Arm II (usual diet) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (commercial kefir beverage), Arm II (usual diet) |
Primary outcome
Changes in levels of parathyroid hormone (PTH)
Time frame: Week 12
Collect Changes in values of PTH from baseline to week 12in patients who added kefir to their diet
Change in quality of life
Time frame: Up to 30 days post-intervention
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
1 secondary outcome
Overall Gut microbial community structure
Time frame: At baseline and after 3 months daily kefir consumption
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 16 Nov 2021.
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
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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.
Jens Hillengass principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Kefir and Quality-of-Life Assessment in people with Plasma Cell Myeloma, run by Roswell Park Cancer Institute 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 6 inclusion and 14 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 16 Nov 2021. 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?
Changes in levels of parathyroid hormone (PTH) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2021.