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Smoldering Multiple MyelomaSPOTLIGHTNCT06212323

Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial

An observational study of Smoldering Multiple Myeloma, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to define the natural history of high-risk smoldering myeloma in a modern cohort of patients undergoing close standard of care follow-up with diffusion weighted whole body magnetic resonance imaging. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoldering Multiple Myeloma
What is being tested?
Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.
How many people
100 participants
Where
1 siteUnited States
Study dates
11 Jan 2024to Mar 2030
Phase
Observational
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

Study population: Smoldering myeloma (SMM)

Who may be able to join

  • Adult subject aged ≥ 18 years.
  • Diagnosis of smoldering myeloma as per the IMWG criteria, specifically:
  • Serum monoclonal protein (IgG or IgA) of 30g/L or greater per 24 hours or urinary monoclonal protein of 500mg or greater per 24 hours and/or
  • Clonal bone marrow plasma cells 10-59% with the absence of myeloma-defining events or amyloidosis
  • High-risk smoldering myeloma defined as two or more out of four of the following criteria:
  • M-spike greater than 2 g/dL
Show all 11Show fewer
  • An involved/uninvolved free light chain ratio greater than 20
  • Bone marrow plasmacytosis greater than 20%
  • Presence of any of translocation (4;14), deletion 17p, deletion 13q or 1q gain by conventional cytogenetics/fluorescence in situ hybridization (FISH) studies) and/or
  • An IMWG SMM score of 9 or greater according to the IMWG risk model for smoldering multiple myeloma (SMM)
  • Diagnosis of high-risk SMM made within 365 days of enrollment in the study. Note: If a patient previously had MGUS or low/intermediate SMM- the date at which high-risk SMM was diagnosed would have to be within 365 days of enrollment in the study.

Who cannot join

  • Presence of any features that would meet diagnostic criteria for myeloma as per the IMWG Criteria
  • Presence of extramedullary plasmacytomas
  • Presence of any focal bone marrow lesions, or lytic bone lesions on imaging done prior to screening or on screening. However, presence of diffuse or patchy infiltration of the marrow (without any clear lesions) on MRI, will not be an exclusion criteria. Patients with 1 focal marrow lesion on MRI that is attributable to plasma cell dyscrasia, will be excluded from study, even if they do not meet criteria for myeloma. Patients with 1 focal marrow lesion can only be enrolled if the lesion does not appear to be related to myeloma, based on the judgement of the investigator. Use of restricted diffusion and ADC values can assist in ascertainment.
  • Creatinine clearance of less than 40ml/min.
  • Presence of AL Amyloidosis (the amount of workup necessary to exclude AL Amyloidosis is per the discretion of the treating investigator, however the investigator must attest that they do not believe AL Amyloidosis to be present at time of enrollment. Serum nt-PROBNP is recommended as part of evaluation in order to ascertain for cardiac amyloidosis).
  • Note: The Hgb cut-offs can vary between institutions (lower cut-off for Hgb University of Utah for men is a Hgb of 14.8, rendering a patient with Hgb of 12.7 as having a CRAB feature). If the Hgb is above 10g/dl but the patient meets the definition of anemia according to the IMWG criteria, by virtue of this being more than 2 g/dl below the limit of normal, the investigator can decide whether to call a patient being considered for screening as having multiple myeloma OR smoldering myeloma and allow enrollment on this study.
  • Given that the values used to define high-risk SMM can change, at time of enrollment, if utilizing at least 2/4 of the 2/20/20+cytogenetics criteria to enroll, participants should meet at least 2/4 of the 2/20/20. If participants had met at least 2/4 previously at some timepoint but do not meet at least 2/4 currently, they cannot be enrolled in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sharmilee Nuli contact

801-585-0255

Sharmilee.Nuli@hci.utah.edu

United States1 site, 1 recruiting

  • Huntsman Cancer Institute at the University of Utah

    Salt Lake City, Utah, 84112

    Bailee Daniels, 801-587-4699, Bailee.Daniels@hci.utah.edu

    Recruiting

Other trials in United States

About this study

The purpose of this study is to define the natural history of high-risk smoldering myeloma in a modern cohort of patients undergoing close standard of care follow-up with diffusion weighted whole body magnetic resonance imaging.

Being tested
Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.
Medical subject headings
Smoldering Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.Other

    Patients with high-risk smoldering myeloma will be prospectively followed and chart review will be performed to determine if progression events happen, and how they happen.

    All patients on the study are recommended to undergo the following standard of care surveillance protocol:

    • Complete Blood Count (CBC), Complete Metabolic Panel (CMP), myeloma blood tests (serum kappa/lambda light chains, monoclonal protein evaluation, immunoglobulin levels), to be done monthly for first year, and then every two months for the second year.
    • WB DW-MRIs every 6 months during the study period.
    • 24-hour urine Immunofixation/electrophoresis is expected to be completed approximately every 6 months.
    • Bone marrow biopsy will be performed annually during the study time-period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of morbid progression events attributable to a plasma cell dyscrasia at two years, with morbid events defined as: death, renal injury that does not reverse, fracture, lytic bone lesion, AL Amyloidosis or plasma cell leukemia.

    Frequency and nature of progression events in a prospective cohort of patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI

    Measured: 2 years

Secondary outcomes (3)

  1. Change in the quality of life as measured by physical function domain on the PROMIS-29 (Patient-Reported Outcomes Measurement Information System), from baseline to the end of study at 24 months of follow-up.

    Determine longitudinal Quality of Life as assessed by the PROMIS-29 instrument. The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of physical function.

    Measured: 2 years

  2. Change in the quality of life as measured by pain interference domain on the PROMIS-29 (Patient-Reported Outcomes Measurement Information System), from baseline to the end of study at 24 months of follow-up.

    Determine longitudinal Quality of Life as assessed by the PROMIS-29 instrument. The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of pain interference.

    Measured: 2 years

  3. Change in the quality of life as measured by anxiety domain on the PROMIS-29 (Patient-Reported Outcomes Measurement Information System), from baseline to the end of study at 24 months of follow-up.

    Determine longitudinal Quality of Life as assessed by the PROMIS-29 instrument. The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of anxiety.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start11 Jan 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06212323
Sponsor's protocol ID
HCI170107
Acronym
SPOTLIGHT
Status last verified
Feb 2026
First submitted
8 Jan 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cowan A, Ferrari F, Freeman SS, Redd R, El-Khoury H, Perry J, Patel V, Kaur P, Barr H, Lee DJ, Lightbody E, Downey K, Argyelan D, Theodorakakou F, Fotiou D, Liacos CI, Kanellias N, Chavda SJ, Ainley L, Sandecka V, Pospisilova L, Minarik J, Jungova A, Radocha J, Spicka I, Nadeem O, Yong K, Hajek R, Kastritis E, Marinac CR, Dimopoulos MA, Get G, Trippa L, Ghobrial IM. Personalised progression prediction in patients with monoclonal gammopathy of undetermined significance or smouldering multiple myeloma (PANGEA): a retrospective, multicohort study. Lancet Haematol. 2023 Mar;10(3):e203-e212. doi: 10.1016/S2352-3026(22)00386-6.

    PubMed 36858677

  • Mateos 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 33067414

  • Lakshman A, Rajkumar SV, Buadi FK, Binder M, Gertz MA, Lacy MQ, Dispenzieri A, Dingli D, Fonder AL, Hayman SR, Hobbs MA, Gonsalves WI, Hwa YL, Kapoor P, Leung N, Go RS, Lin Y, Kourelis TV, Warsame R, Lust JA, Russell SJ, Zeldenrust SR, Kyle RA, Kumar SK. Risk stratification of smoldering multiple myeloma incorporating revised IMWG diagnostic criteria. Blood Cancer J. 2018 Jun 12;8(6):59. doi: 10.1038/s41408-018-0077-4.

    PubMed 29895887

  • Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.

    PubMed 25439696

  • Thorsteinsdottir S, Gislason GK, Aspelund T, Rognvaldsson S, Oskarsson JThorn, Sigurethardottir GA, Thornorethardottir AR, Vietharsson B, Onundarson PT, Agnarsson BA, Sigurethardottir M, Thornorsteinsdottir I, Olafsson I, Eythornorsson E, Jonsson A, Berlanga O, Hultcrantz M, Durie BGM, Love TJ, Harding S, Landgren O, Kristinsson SY. Prevalence of smoldering multiple myeloma based on nationwide screening. Nat Med. 2023 Feb;29(2):467-472. doi: 10.1038/s41591-022-02183-6. Epub 2023 Feb 6.

    PubMed 36747117

  • Hillengass J, Moulopoulos LA, Delorme S, Koutoulidis V, Mosebach J, Hielscher T, Drake M, Rajkumar SV, Oestergaard B, Abildgaard N, Hinge M, Plesner T, Suehara Y, Matsue K, Withofs N, Caers J, Waage A, Goldschmidt H, Dimopoulos MA, Lentzsch S, Durie B, Terpos E. Whole-body computed tomography versus conventional skeletal survey in patients with multiple myeloma: a study of the International Myeloma Working Group. Blood Cancer J. 2017 Aug 25;7(8):e599. doi: 10.1038/bcj.2017.78.

    PubMed 28841211

  • Siontis B, Kumar S, Dispenzieri A, Drake MT, Lacy MQ, Buadi F, Dingli D, Kapoor P, Gonsalves W, Gertz MA, Rajkumar SV. Positron emission tomography-computed tomography in the diagnostic evaluation of smoldering multiple myeloma: identification of patients needing therapy. Blood Cancer J. 2015 Oct 23;5(10):e364. doi: 10.1038/bcj.2015.87.

    PubMed 26495861

  • Perez-Persona E, Vidriales MB, Mateo G, Garcia-Sanz R, Mateos MV, de Coca AG, Galende J, Martin-Nunez G, Alonso JM, de Las Heras N, Hernandez JM, Martin A, Lopez-Berges C, Orfao A, San Miguel JF. New criteria to identify risk of progression in monoclonal gammopathy of uncertain significance and smoldering multiple myeloma based on multiparameter flow cytometry analysis of bone marrow plasma cells. Blood. 2007 Oct 1;110(7):2586-92. doi: 10.1182/blood-2007-05-088443. Epub 2007 Jun 18.

    PubMed 17576818

  • Dispenzieri A, Kyle RA, Katzmann JA, Therneau TM, Larson D, Benson J, Clark RJ, Melton LJ 3rd, Gertz MA, Kumar SK, Fonseca R, Jelinek DF, Rajkumar SV. Immunoglobulin free light chain ratio is an independent risk factor for progression of smoldering (asymptomatic) multiple myeloma. Blood. 2008 Jan 15;111(2):785-9. doi: 10.1182/blood-2007-08-108357. Epub 2007 Oct 17.

    PubMed 17942755

  • Hill E, Dew A, Morrison C, Yuan C, Stetler-Stevenson M, Landgren O, Kazandjian D. Assessment of Discordance Among Smoldering Multiple Myeloma Risk Models. JAMA Oncol. 2021 Jan 1;7(1):132-134. doi: 10.1001/jamaoncol.2020.5585.

    PubMed 33211080

  • Lonial S, Jacobus S, Fonseca R, Weiss M, Kumar S, Orlowski RZ, Kaufman JL, Yacoub AM, Buadi FK, O'Brien T, Matous JV, Anderson DM, Emmons RV, Mahindra A, Wagner LI, Dhodapkar MV, Rajkumar SV. Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma. J Clin Oncol. 2020 Apr 10;38(11):1126-1137. doi: 10.1200/JCO.19.01740. Epub 2019 Oct 25.

    PubMed 31652094

  • Mateos MV, Hernandez MT, Giraldo P, de la Rubia J, de Arriba F, Lopez Corral L, Rosinol L, Paiva B, Palomera L, Bargay J, Oriol A, Prosper F, Lopez J, Olavarria E, Quintana N, Garcia JL, Blade J, Lahuerta JJ, San Miguel JF. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013 Aug 1;369(5):438-47. doi: 10.1056/NEJMoa1300439.

    PubMed 23902483

  • Mateos MV, Hernandez MT, Salvador C, Rubia J, de Arriba F, Lopez-Corral L, Rosinol L, Paiva B, Palomera L, Bargay J, Oriol A, Prosper F, Lopez J, Arguinano JM, Blade J, Lahuerta JJ, San-Miguel J. Lenalidomide-dexamethasone versus observation in high-risk smoldering myeloma after 12 years of median follow-up time: A randomized, open-label study. Eur J Cancer. 2022 Oct;174:243-250. doi: 10.1016/j.ejca.2022.07.030. Epub 2022 Sep 5.

    PubMed 36067617

  • Wennmann M, Goldschmidt H, Mosebach J, Hielscher T, Bauerle T, Komljenovic D, McCarthy PL, Merz M, Schlemmer HP, Raab MS, Sauer S, Delorme S, Hillengass J. Whole-body magnetic resonance imaging plus serological follow-up for early identification of progression in smouldering myeloma patients to prevent development of end-organ damage. Br J Haematol. 2022 Oct;199(1):65-75. doi: 10.1111/bjh.18232. Epub 2022 May 24.

    PubMed 35608264

  • Hays RD, Spritzer KL, Schalet BD, Cella D. PROMIS(R)-29 v2.0 profile physical and mental health summary scores. Qual Life Res. 2018 Jul;27(7):1885-1891. doi: 10.1007/s11136-018-1842-3. Epub 2018 Mar 22.

    PubMed 29569016

Questions about this trial

What is this clinical trial studying?

An observational study of Smoldering Multiple Myeloma, run by University of Utah 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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?

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 Sharmilee Nuli (801-585-0255, Sharmilee.Nuli@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of morbid progression events attributable to a plasma cell dyscrasia at two years, with morbid events defined as: death, renal injury that does not reverse, fracture, lytic bone lesion, AL Amyloidosis or plasma cell leukemia. (time frame: 2 years). 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 NCT06212323, which also lists 16 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 17 Feb 2026.

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