Monoclonal Gammopathy of Undetermined Significance, Plasma Cell Myeloma
Conditions
Brief summary
This clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) compared to multiple myeloma (MM). Results from this study may identify metabolic differences between pre-malignant and malignant clonal plasma cells in MGUS and MM, respectively. It may also allow researchers better determine the transition from MGUS to MM for the development of potential early diagnostic purposes of preventative strategies.
Detailed description
PRIMARY OBJECTIVE: I. Compare the glutamine anaplerosis activity in bone marrow clonal plasma cells (cPCs) between patients with MGUS and MM using an in vivo and an ex vivo approach. SECONDARY OBJECTIVES: I. Compare the tricarboxylic acid (TCA) isotopomer enrichment in the bone marrow plasma obtained from patients with MGUS and MM with the in vivo approach. II. Determine the peripheral blood enrichment of 13C in the TCA cycle intermediates from patients with MGUS and MM with the in vivo approach. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I (EX-VIVO): After an overnight fast of 6 hours, patients undergo collection of blood samples. GROUP II (IN VIVO): After an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose intravenously (IV) over 90 minutes. Patients also undergo collection of blood and bone marrow aspirate samples. After completion of study, patient are followed up for 4 weeks.
Interventions
OTHER5-Carbon C 13-labeled Glutamine
Given IV
PROCEDUREBiospecimen Collection
Undergo collection of blood
Given IV
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * International Myeloma Working Group (IMWG) criteria for the diagnosis of either MGUS or MM
Exclusion criteria
* Unable to provide consent * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3 * Hemoglobin \< 8 g/dL * Women who are pregnant * Prior history of adverse events with conscious sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent enrichment of 13-Carbon in the tricarboxylic acid (TCA) cycle intermediates within bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma | Up to 1 day | Will compare the glutamine anaplerosis activity in bone marrow clonal plasma cells between patients with MGUS and multiple myeloma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma from patients with MGUS and multiple myeloma | Up to 1 day | Will compare the glutamine anaplerosis activity in the plasma cells by assessing the bone marrow plasma between patients with MGUS and multiple myeloma. |
| Percent enrichment of 13-Carbon in the TCA cycle intermediates within the peripheral blood plasma from patients with MGUS and multiple myeloma | Up to 1 day | Will compare the peripheral blood enrichment of 13-carbon in the TCA cycle intermediates from patients with MGUS and multiple myeloma. |
Countries
United States
Outcome results
None listed