Study Of Circulating Multiple Myeloma Cells As A Biomarker of MGUS And SMM

NCT ID: NCT01958528

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-23
• Study Completion Date: 2019-01-22

Brief Summary

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.

Detailed Description

The primary objective is to evaluate CMMCs as a biomarker to detect patients at high risk of progression to multiple myeloma in patients with MGUS and SMM. The secondary objective are to correlate CMMCs with the Mayo Clinic prognostic models in MGUS/SMM, to compare bone marrow genomic findings with genomic findings in CMMC (utilizing multiple myeloma FISH panel), to perform immunophenotyping of bone marrow plasma cells, to perform gene expression profiling on CD138+bone marrow plasma cells and correlate with progression, to perform serum microRNA profiling and correlate with progression, to correlate bone marrow immunohistochemical studies evaluating the microenvironment with CMMC, to perform proteomic profiling on peripheral blood to evaluate serum biomarkers of progression and to establish a biorepository of samples of peripheral blood for future studies.

Conditions

a Diagnosis of MGUS or SMM by IMWG Criteria

Study Design

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

Study Groups

Cohort 1 Progressors

No interventions assigned to this group

Cohort 2 - Non-Progressors

No interventions assigned to this group

Eligibility Criteria

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-up

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

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfred Garfall, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 28412

Identifier Type: -

Identifier Source: org_study_id