Monoclonal Gammopathy of Uncertain SignificanceNCT06987708
Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers
A study testing The Multimodal Lifestyle Intervention in people with Monoclonal Gammopathy of Uncertain Significance and Smoldering Myeloma, run by Hackensack Meridian Health.
Trial summary
A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Uncertain Significance, Smoldering Myeloma
- What is being tested?
- The Multimodal Lifestyle Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults 18 years or older.
- Diagnosed with MGUS or SM based on commonly accepted criteria per the
- International Multiple Myeloma Working Group (IMWG), defined as follows:
- For a diagnosis of Smoldering Multiple Myeloma (SM), both criteria must be met: i. Serum monoclonal protein (IgG or IgA) ≥ 30g/L or urinary monoclonal protein ≥ 500mg per 24h and/or clonal bone marrow plasma cells 10-60% ii. Absence of myeloma-defining events or amyloidosis b. For a diagnosis of Non-IgM Monoclonal Gammopathy of Undetermined
- Significance (MGUS):
- Serum monoclonal protein <30g/L ii. Clonal bone marrow plasma cells <10% iii. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder c. For a diagnosis of IgM MGUS: i. Serum IgM monoclonal protein <30g/L ii. No evidence of anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, hepatosplenomegaly, or other end-organ damage that can be attributed to the plasma cell proliferative disorder d. For a diagnosis of light change MGUS: i. Abnormal FLC ratio (<0.26 or >1.65) ii. Increased level of the appropriate free light chain (increased κ FLC in patients with ratio >1.65 and increased λ FLC in patients with ratio <0.26) iii. No immunoglobulin heavy chain expression on immunofixation iv. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder v. Clonal bone marrow plasma cells <10% vi. Urinary monoclonal protein <500mg/24h
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- Ability to speak, read and comprehend the English language.
- Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which would preclude informed consent.
- Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
- Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.
Who cannot join
- Evidence of any one or more of the following biomarkers of malignancy, or myeloma-defining events (MDEs) meeting IMWG criteria for a diagnosis of multiple myeloma:
- 60% or greater clonal plasma cells on bone marrow examination
- Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100mg/L (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)
- More than one focal lesion on MRI that is at least 5mm or greater in size.
- Evidence of end-organ damage as per the IMWG CRAB criteria, defined as follows:
- Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL)
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- Renal insufficiency: creatinine clearance <40 mL per minute or serum creatinine >177mol/L (>2mg/dL)
- Anemia: hemoglobin value of >20g/L below the lowest limit of normal, or a hemoglobin value <100g/L
- Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement
- Unwillingness or inability to follow required intervention behaviors, including any safety issues related to participating in any part of the intervention (e.g., a contraindication to gentle movement/exercise, BMI <18 kg/m2, etc.).
- Pregnancy or breastfeeding
- Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers Associated With Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Myeloma (SM): A Prospective Intervention Pilot Study
A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year.
Read the detailed description
Patients with a diagnosis of MGUS or SM who are willing and able to participate in this 12-month multimodal lifestyle approach. Eligible patients include those 18 years of age and older diagnosed with MGUS/SM, ECOG PS 0-2, absence of significant comorbidities, and ability to speak/read/understand English.
The multimodal lifestyle intervention has six foci: Positive cognition [mindset], Exercise/movement, Stress Reduction, Social Connection, Emotional Wellbeing, and Nutrition. All programming will take place online to maximize convenience/sustained participation.
- Being tested
- The Multimodal Lifestyle Intervention
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Multimodal Lifestyle InterventionOther
The multimodal lifestyle intervention has six foci: positive cognition, exercise/movement, stress reduction, social connection, emotional well-being, and nutrition
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Lifestyle Intervention | Experimental | Not described Receives: Other: The Multimodal Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of multi-modal lifestyle intervention based on any of the 3 specified myeloma tumor burden biomarker surrogates
Efficacy of the multi-modal lifestyle intervention will be based on measurements of 3 myeloma-relevant biomarkers: M-Spike Protein, Free kappa light chains, and Free lambda-light chains. We will first determine which monoclonal protein is dominant for a given patient based on his/her/their individual lab values. These labs will be taken at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for changes in protein levels.
Measured: At study entry, 4 months, 8 months, and up to 12 months
Secondary outcomes (2)
Patient Acceptability (engagement) of the Lifestyle Intervention
Patient acceptability will be measured by a patient acceptability questionnaire
Measured: At study entry, 4 months, 8 months, and up to 12 months
Patient Adherence (compliance) to the Lifestyle Intervention
Patient adherence will be measured based on attendance at clinic visits, the various scheduled individual and group meetings across all intervention components, and via the use of wearable technology
Measured: At study entry, 4 months, 8 months, and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (168)Papers the sponsor has linked to this study.
- Other trials for Monoclonal Gammopathy of Uncertain SignificanceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cancer Lifestyle Management
- Responsible party
- Sponsor
- Investigators
- David Siegel, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987708
- Sponsor's protocol ID
- Pro2024-0235
- Other IDs
- MGUS-SM-Lifestyle
- Status last verified
- Aug 2026
- First submitted
- 16 May 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mateos MV, Landgren O. MGUS and Smoldering Multiple Myeloma: Diagnosis and Epidemiology. Cancer Treat Res. 2016;169:3-12. doi: 10.1007/978-3-319-40320-5_1.
PubMed 27696254Plano F, Corsale AM, Gigliotta E, Camarda G, Vullo C, Di Simone M, Shekarkar Azgomi M, Speciale M, Carlisi M, Caccamo N, Dieli F, Meraviglia S, Siragusa S, Botta C. Monoclonal Gammopathies and the Bone Marrow Microenvironment: From Bench to Bedside and Then Back Again. Hematol Rep. 2023 Jan 9;15(1):23-49. doi: 10.3390/hematolrep15010004.
PubMed 36648882Padala SA, Barsouk A, Barsouk A, Rawla P, Vakiti A, Kolhe R, Kota V, Ajebo GH. Epidemiology, Staging, and Management of Multiple Myeloma. Med Sci (Basel). 2021 Jan 20;9(1):3. doi: 10.3390/medsci9010003.
PubMed 33498356Cancer.Org. Published 2012. Https://Www.Cancer.Org/Cancer/Multiple-Myeloma/Detectiondiagnosis-Staging/Surviva l-Rates.Html. Accessed January 19, 2023.
Multiple Myeloma - Statistics. Cancer.Net. Published February 28, 2019. Https://Www.Cancer.Net/Cancer-Types/Multiple-Myeloma/Statistics. Accessed January 19, 2023.
Kyle RA, Remstein ED, Therneau TM, Dispenzieri A, Kurtin PJ, Hodnefield JM, Larson DR, Plevak MF, Jelinek DF, Fonseca R, Melton LJ 3rd, Rajkumar SV. Clinical course and prognosis of smoldering (asymptomatic) multiple myeloma. N Engl J Med. 2007 Jun 21;356(25):2582-90. doi: 10.1056/NEJMoa070389.
PubMed 17582068Mateos MV, Kumar S, Dimopoulos MA, Gonzalez-Calle V, Kastritis E, Hajek R, De Larrea CF, Morgan GJ, Merlini G, Goldschmidt H, Geraldes C, Gozzetti A, Kyriakou C, Garderet L, Hansson M, Zamagni E, Fantl D, Leleu X, Kim BS, Esteves G, Ludwig H, Usmani S, Min CK, Qi M, Ukropec J, Weiss BM, Rajkumar SV, Durie BGM, San-Miguel J. International Myeloma Working Group risk stratification model for smoldering multiple myeloma (SMM). Blood Cancer J. 2020 Oct 16;10(10):102. doi: 10.1038/s41408-020-00366-3.
PubMed 33067414Aljama MA, Sidiqi MH, Lakshman A, Dispenzieri A, Jevremovic D, Gertz MA, Lacy MQ, Buadi FK, Dingli D, Muchtar E, Fonder AL, Hayman SR, Hobbs MA, Gonsalves WI, Warsame R, Kourelis TV, Hwa YL, Kapoor P, Leung N, Go RS, Kyle RA, Rajkumar SV, Kumar SK. Plasma cell proliferative index is an independent predictor of progression in smoldering multiple myeloma. Blood Adv. 2018 Nov 27;2(22):3149-3154. doi: 10.1182/bloodadvances.2018024794.
PubMed 30463914Chang SH, Gumbel J, Luo S, Thomas TS, Sanfilippo KM, Luo J, Colditz GA, Carson KR. Post-MGUS Diagnosis Serum Monoclonal-Protein Velocity and the Progression of Monoclonal Gammopathy of Undetermined Significance to Multiple Myeloma. Cancer Epidemiol Biomarkers Prev. 2019 Dec;28(12):2055-2061. doi: 10.1158/1055-9965.EPI-19-0132. Epub 2019 Sep 9.
PubMed 31501149Shapiro YN, Peppercorn JM, Yee AJ, Branagan AR, Raje NS, Donnell EKO. Lifestyle considerations in multiple myeloma. Blood Cancer J. 2021 Oct 26;11(10):172. doi: 10.1038/s41408-021-00560-x.
PubMed 34702799Lee DH, Fung TT, Tabung FK, Marinac CR, Devore EE, Rosner BA, Ghobrial IM, Colditz GA, Giovannucci EL, Birmann BM. Prediagnosis dietary pattern and survival in patients with multiple myeloma. Int J Cancer. 2020 Oct 1;147(7):1823-1830. doi: 10.1002/ijc.32928. Epub 2020 Feb 28.
PubMed 32067221Lee DH, Fung TT, Tabung FK, Colditz GA, Ghobrial IM, Rosner BA, Giovannucci EL, Birmann BM. Dietary Pattern and Risk of Multiple Myeloma in Two Large Prospective US Cohort Studies. JNCI Cancer Spectr. 2019 Jun;3(2):pkz025. doi: 10.1093/jncics/pkz025. Epub 2019 Apr 27.
PubMed 31149654Aggarwal V, Kashyap D, Sak K, Tuli HS, Jain A, Chaudhary A, Garg VK, Sethi G, Yerer MB. Molecular Mechanisms of Action of Tocotrienols in Cancer: Recent Trends and Advancements. Int J Mol Sci. 2019 Feb 2;20(3):656. doi: 10.3390/ijms20030656.
PubMed 30717416Gong IY, Cheung MC, Read S, Na Y, Lega IC, Lipscombe LL. Association between diabetes and haematological malignancies: a population-based study. Diabetologia. 2021 Mar;64(3):540-551. doi: 10.1007/s00125-020-05338-7. Epub 2021 Jan 6.
PubMed 33409570Parikh R, Tariq SM, Marinac CR, Shah UA. A comprehensive review of the impact of obesity on plasma cell disorders. Leukemia. 2022 Feb;36(2):301-314. doi: 10.1038/s41375-021-01443-7. Epub 2021 Oct 15.
PubMed 34654885
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers Associated With Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Myeloma (SM): A Prospective Intervention Pilot Study
- ClinicalTrials.gov ID
- NCT06987708
- Acronym / sponsor ID
- Pro2024-0235
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Center for Cancer Lifestyle Management
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 23 May 2025 (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.
A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year.
Detailed description
Patients with a diagnosis of MGUS or SM who are willing and able to participate in this 12-month multimodal lifestyle approach. Eligible patients include those 18 years of age and older diagnosed with MGUS/SM, ECOG PS 0-2, absence of significant comorbidities, and ability to speak/read/understand English.
The multimodal lifestyle intervention has six foci: Positive cognition [mindset], Exercise/movement, Stress Reduction, Social Connection, Emotional Wellbeing, and Nutrition. All programming will take place online to maximize convenience/sustained participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Lifestyle Intervention | Experimental | Other: The Multimodal Lifestyle Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults 18 years or older.
- Diagnosed with MGUS or SM based on commonly accepted criteria per the
- For a diagnosis of Smoldering Multiple Myeloma (SM), both criteria must be met: i. Serum monoclonal protein (IgG or IgA) ≥ 30g/L or urinary monoclonal protein ≥ 500mg per 24h and/or clonal bone marrow plasma cells 10-60% ii. Absence of myeloma-defining events or amyloidosis b. For a diagnosis of Non-IgM Monoclonal Gammopathy of Undetermined
- Serum monoclonal protein <30g/L ii. Clonal bone marrow plasma cells <10% iii. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder c. For a diagnosis of IgM MGUS: i. Serum IgM monoclonal protein <30g/L ii. No evidence of anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, hepatosplenomegaly, or other end-organ damage that can be attributed to the plasma cell proliferative disorder d. For a diagnosis of light change MGUS: i. Abnormal FLC ratio (<0.26 or >1.65) ii. Increased level of the appropriate free light chain (increased κ FLC in patients with ratio >1.65 and increased λ FLC in patients with ratio <0.26) iii. No immunoglobulin heavy chain expression on immunofixation iv. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder v. Clonal bone marrow plasma cells <10% vi. Urinary monoclonal protein <500mg/24h
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
Key exclusion criteria (12 listed)
- Evidence of any one or more of the following biomarkers of malignancy, or myeloma-defining events (MDEs) meeting IMWG criteria for a diagnosis of multiple myeloma:
- Evidence of end-organ damage as per the IMWG CRAB criteria, defined as follows:
- Unwillingness or inability to follow required intervention behaviors, including any safety issues related to participating in any part of the intervention (e.g., a contraindication to gentle movement/exercise, BMI <18 kg/m2, etc.).
- Pregnancy or breastfeeding
- Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
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 |
|---|---|---|
| The Multimodal Lifestyle InterventionThe multimodal lifestyle intervention has six foci: positive cognition, exercise/movement, stress reduction, social connection, emotional well-being, and nutrition | Other | Multimodal Lifestyle Intervention |
Primary outcome
Efficacy of multi-modal lifestyle intervention based on any of the 3 specified myeloma tumor burden biomarker surrogates
Time frame: At study entry, 4 months, 8 months, and up to 12 months
Efficacy of the multi-modal lifestyle intervention will be based on measurements of 3 myeloma-relevant biomarkers: M-Spike Protein, Free kappa light chains, and Free lambda-light chains. We will first determine which monoclonal protein is dominant for a given patient based on his/her/their individual lab values. These labs will be taken at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for changes in protein levels.
2 secondary outcomes
Patient Acceptability (engagement) of the Lifestyle Intervention
Time frame: At study entry, 4 months, 8 months, and up to 12 months
Patient Adherence (compliance) to the Lifestyle Intervention
Time frame: At study entry, 4 months, 8 months, and up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 27696254Mateos MV, Landgren O. MGUS and Smoldering Multiple Myeloma: Diagnosis and Epidemiology. Cancer Treat Res. 2016;169:3-12. doi: 10.1007/978-3-319-40320-5_1.
- Background: PubMed 36648882Plano F, Corsale AM, Gigliotta E, Camarda G, Vullo C, Di Simone M, Shekarkar Azgomi M, Speciale M, Carlisi M, Caccamo N, Dieli F, Meraviglia S, Siragusa S, Botta C. Monoclonal Gammopathies and the Bone Marrow Microenvironment: From Bench to Bedside and Then Back Again. Hematol Rep. 2023 Jan 9;15(1):23-49. doi: 10.3390/hematolrep15010004.
- Background: PubMed 33498356Padala SA, Barsouk A, Barsouk A, Rawla P, Vakiti A, Kolhe R, Kota V, Ajebo GH. Epidemiology, Staging, and Management of Multiple Myeloma. Med Sci (Basel). 2021 Jan 20;9(1):3. doi: 10.3390/medsci9010003.
- BackgroundCancer.Org. Published 2012. Https://Www.Cancer.Org/Cancer/Multiple-Myeloma/Detectiondiagnosis-Staging/Surviva l-Rates.Html. Accessed January 19, 2023.
- BackgroundMultiple Myeloma - Statistics. Cancer.Net. Published February 28, 2019. Https://Www.Cancer.Net/Cancer-Types/Multiple-Myeloma/Statistics. Accessed January 19, 2023.
- Background: PubMed 17582068Kyle RA, Remstein ED, Therneau TM, Dispenzieri A, Kurtin PJ, Hodnefield JM, Larson DR, Plevak MF, Jelinek DF, Fonseca R, Melton LJ 3rd, Rajkumar SV. Clinical course and prognosis of smoldering (asymptomatic) multiple myeloma. N Engl J Med. 2007 Jun 21;356(25):2582-90. doi: 10.1056/NEJMoa070389.
- Background: PubMed 33067414Mateos MV, Kumar S, Dimopoulos MA, Gonzalez-Calle V, Kastritis E, Hajek R, De Larrea CF, Morgan GJ, Merlini G, Goldschmidt H, Geraldes C, Gozzetti A, Kyriakou C, Garderet L, Hansson M, Zamagni E, Fantl D, Leleu X, Kim BS, Esteves G, Ludwig H, Usmani S, Min CK, Qi M, Ukropec J, Weiss BM, Rajkumar SV, Durie BGM, San-Miguel J. International Myeloma Working Group risk stratification model for smoldering multiple myeloma (SMM). Blood Cancer J. 2020 Oct 16;10(10):102. doi: 10.1038/s41408-020-00366-3.
- Background: PubMed 30463914Aljama MA, Sidiqi MH, Lakshman A, Dispenzieri A, Jevremovic D, Gertz MA, Lacy MQ, Buadi FK, Dingli D, Muchtar E, Fonder AL, Hayman SR, Hobbs MA, Gonsalves WI, Warsame R, Kourelis TV, Hwa YL, Kapoor P, Leung N, Go RS, Kyle RA, Rajkumar SV, Kumar SK. Plasma cell proliferative index is an independent predictor of progression in smoldering multiple myeloma. Blood Adv. 2018 Nov 27;2(22):3149-3154. doi: 10.1182/bloodadvances.2018024794.
- Background: PubMed 31501149Chang SH, Gumbel J, Luo S, Thomas TS, Sanfilippo KM, Luo J, Colditz GA, Carson KR. Post-MGUS Diagnosis Serum Monoclonal-Protein Velocity and the Progression of Monoclonal Gammopathy of Undetermined Significance to Multiple Myeloma. Cancer Epidemiol Biomarkers Prev. 2019 Dec;28(12):2055-2061. doi: 10.1158/1055-9965.EPI-19-0132. Epub 2019 Sep 9.
- Background: PubMed 34702799Shapiro YN, Peppercorn JM, Yee AJ, Branagan AR, Raje NS, Donnell EKO. Lifestyle considerations in multiple myeloma. Blood Cancer J. 2021 Oct 26;11(10):172. doi: 10.1038/s41408-021-00560-x.
- Background: PubMed 32067221Lee DH, Fung TT, Tabung FK, Marinac CR, Devore EE, Rosner BA, Ghobrial IM, Colditz GA, Giovannucci EL, Birmann BM. Prediagnosis dietary pattern and survival in patients with multiple myeloma. Int J Cancer. 2020 Oct 1;147(7):1823-1830. doi: 10.1002/ijc.32928. Epub 2020 Feb 28.
- Background: PubMed 31149654Lee DH, Fung TT, Tabung FK, Colditz GA, Ghobrial IM, Rosner BA, Giovannucci EL, Birmann BM. Dietary Pattern and Risk of Multiple Myeloma in Two Large Prospective US Cohort Studies. JNCI Cancer Spectr. 2019 Jun;3(2):pkz025. doi: 10.1093/jncics/pkz025. Epub 2019 Apr 27.
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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.
David Siegel, MD principal investigator
Hackensack Meridian Health
Questions about this trial
What is this clinical trial studying?
A study testing The Multimodal Lifestyle Intervention in people with Monoclonal Gammopathy of Uncertain Significance and Smoldering Myeloma, run by Hackensack Meridian Health.
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 11 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oncology Clinical Research Referral Office (551-996-1777, OncologyResearchReferral@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of multi-modal lifestyle intervention based on any of the 3 specified myeloma tumor burden biomarker surrogates (time frame: At study entry, 4 months, 8 months, and up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06987708, which also lists 168 linked publications.
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 24 Aug 2026.