TriangleNCT04920084 · STUDY IN CONTEXT
A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04920084
- trial label
- A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04920084
- outcome key
- om-0000
- source section id
- NCT04920084-om-0000
- source outcome index
- 0
- endpoint
- Difference of Body Mass Index From Baseline to Week 12
- endpoint definition
- Weight loss is defined as the average decrease in BMI at 12 weeks
- time origin
- 12 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04920084
- outcome key
- om-0001
- source section id
- NCT04920084-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks
- endpoint definition
- Intervention defined as ≥70% of participants consuming a whole food, plant-based diet/WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey).
- time origin
- 12 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04920084
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Plant-based Meals
- regimen
- 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. Plant based meals: For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to an online portal from Plantable which contains education materials and access to a coach daily for 24 weeks.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04920084-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04920084
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Plant-based Meals
- regimen
- 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. Plant based meals: For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to an online portal from Plantable which contains education materials and access to a coach daily for 24 weeks.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04920084-om-0001#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04920084
- harm key
- EG000
- source section id
- NCT04920084-ae
- event group key
- EG000
- event group label
- Plant-based Meals
- serious affected
- 14
- serious at risk
- 23
- other affected
- 15
- other at risk
- 23
- frequency threshold
- 0
- collection period
- 12 weeks
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice