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Plant-Based Diet for Early Stage Multiple Myeloma
N/A
Waitlist Available
Led By Urvi Shah, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of MGUS or SMM
ECOG performance status of 0-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test whether a plant-based diet is feasible and effective for people with early stage multiple myeloma.
Who is the study for?
This trial is for overweight adults with MGUS or SMM who have a BMI of 25 or higher, an M spike ≥0.2 g/dL, and are willing to learn plant-based cooking. Excluded are those with severe allergies, current participation in other studies or dietary programs, certain medical conditions as judged by the investigator, non-English speakers, and those already on vegan diets.Check my eligibility
What is being tested?
The study is testing the feasibility and effectiveness of a plant-based diet in preventing multiple myeloma among participants with MGUS or SMM. It will measure weight loss adherence to the diet's practicality and its impact on quality of life.See study design
What are the potential side effects?
Since this trial involves a dietary intervention (plant-based meals), side effects may be minimal but could include digestive changes due to new foods introduced into the diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MGUS or SMM.
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I can care for myself but may not be able to do heavy physical work.
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My condition involves abnormal fluid production.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient adherence to the diet
Weight loss- body mass index (BMI) reduction
Trial Design
1Treatment groups
Experimental Treatment
Group I: Plant-based mealsExperimental Treatment1 Intervention
Patients who will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.Participants will be asked to complete a survey via MSK Engage and a notification will be sent via email notification.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,781 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,144 Patients Enrolled for Multiple Myeloma
Urvi Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
271 Total Patients Enrolled
3 Trials studying Multiple Myeloma
271 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently part of a weight loss, diet, or exercise program.I am mentally capable of following study procedures.You have high levels of a specific protein called M spike or abnormal levels of a certain type of light chain in your blood.You have severe allergies, like a serious reaction to peanuts.You are currently pregnant.I have been diagnosed with MGUS or SMM.I can care for myself but may not be able to do heavy physical work.You have tested positive for hepatitis B, hepatitis C, or HIV.I do not speak English.You have severe imbalances in your body's minerals that need to be fixed before joining the study.You weigh more than what is considered healthy for your height.You are allergic to legumes.People who currently eat only plant-based foods or follow a vegan diet are not allowed to participate (people who eat eggs and dairy are allowed).My condition involves abnormal fluid production.If you have diabetes, you can still participate, but you need to see your doctor regularly during the trial.I am 18 years old or older.You want to learn how to cook recipes using only plant-based ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Plant-based meals
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of people that can join this clinical trial?
"That is accurate. The clinical trial in question, which was first advertised on 6/3/2021, is still looking for 20 individuals to participate. These potential participants can go to one of seven different locations, as listed on clinicaltrials.gov"
Answered by AI
Are there any participating hospitals in North America?
"There are a total of 7 enrolling patients for this study. 3 locations are in New york, Uniondale, and Middletown. The other 4 sites are located elsewhere."
Answered by AI
Is it still possible to sign up for this research project?
"The clinical trial is still enrolling patients, as indicated by the website clinicaltrials.gov. This information was initially posted on 6/3/2021 and updated as recently as 4/11/2022."
Answered by AI
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