Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial

NCT ID: NCT06212323

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2029-01-31

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.

Conditions

Smoldering Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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 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.

Intervention Type: OTHER

Eligibility 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ghulam Rehman Mohyuddin, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Locations

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sharmilee Nuli

Role: CONTACT

Sharmilee.Nuli@hci.utah.edu

801-585-0255

Facility Contacts

Bailee Daniels

Role: primary

Bailee.Daniels@hci.utah.edu

801-587-4699

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HCI170107

Identifier Type: -

Identifier Source: org_study_id