Clinical trial · Observational
Study Of Circulating Multiple Myeloma Cells As A Biomarker of MGUS And SMM
A Prospective Study Of Circulating Multiple Myeloma Cells As A Biomarker Of Progression In Myeloma Precursor States (MGUS And SMM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective study to collect blood and bone marrow samples from patients with SM and MGUS. About 100 subjects will be enrolled at the University of Pennsylvania and followed for 2 years. The primary objective of this study is to evaluate CMMCs as a biomarker to detect patients at high risk of progression to multiple myeloma in patients with MGUS and SMM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| a Diagnosis of MGUS or SMM by IMWG Criteria | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1 Progressors
- label
- Cohort 2 - Non-Progressors
Primary outcomes (1)
- measure
- Time to Progression
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Age 18 or greater
* Capable of informed consent
* A monoclonal gammopathy detected in the serum, including intact immunoglobulin (IgG and IgA) and light chain only gammopathies. Light chain only gammopathy is defined as an abnormal light chain ratio and increased involved light chain).44, 45
* Absence of myeloma related organ or tissue impairment ("CRAB") as defined by:
* Hypercalcemia (calcium greater than or equal to 11)
* Renal failure (creatinine \>2.0)
* Anemia hemoglobin \<10 gm/dl)
* Bone disease (Osteolytic lesions, fractures)
Exclusion Criteria:
* A secondary B-cell neoplasm or other active malignancy aside from non-melanoma skin cancer or localized prostate cancer. An active malignancy is any malignancy requiring therapy within the past 3 years. Patients with monoclonal B-cell lymphocytosis are not excluded.
* IgM monoclonal gammopathy
* Inability to comply with follow-upReferences
Publications (0)
Data not yet available