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Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial (SPOTLIGHT)

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ClinicalTrials.gov Identifier: NCT06212323
Recruitment Status : Recruiting
First Posted : January 18, 2024
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Smoldering Multiple Myeloma Other: Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
Actual Study Start Date : January 11, 2024
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Intervention Details:
  • Other: Patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI.

    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 will undergo the following standard of care interventions:

    • Imaging every 6 months with diffusion weighted whole body magnetic resonance imaging
    • Bone marrow biopsy every year
    • Labs every month for first year, and every two months for second year.

Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 2 years ]
    Frequency and nature of progression events in a prospective cohort of patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI


Secondary Outcome Measures :
  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. [ Time Frame: 2 years ]
    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.

  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. [ Time Frame: 2 years ]
    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.

  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. [ Time Frame: 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Smoldering myeloma (SMM)
Criteria

Inclusion Criteria:

  • 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
    • 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.

Exclusion Criteria:

  • 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.
  • 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).
  • Hemoglobin of less than 11g/dl, unless a clearly reversible reason for anemia is identified, at which point they can be rescreened in two months if Hgb is greater than 11g/dl.

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06212323


Contacts
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Contact: Sharmilee Nuli 801-585-0255 Sharmilee.Nuli@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute at the University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Bailee Daniels    801-587-4699    Bailee.Daniels@hci.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Ghulam Rehman Mohyuddin, MD Huntsman Cancer Institute
More Information
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT06212323    
Other Study ID Numbers: HCI170107
First Posted: January 18, 2024    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions
Hypergammaglobulinemia