RECRUITING

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

Conditions

Monoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.

Official Title

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)

Quick Facts

Study Start:2015-12-14

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02726750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with monoclonal gammopathy of unknown significance. Both criteria must be met: * Serum monoclonal protein \< 3 g/dL or urinary monoclonal protein \< 500 mg per 24 hours and clonal bone marrow plasma cells \< 10% * Absence of myeloma defining events or amyloidosis * Patients with smoldering multiple myeloma. Both criteria must be met: * Serum monoclonal protein \>= 3 g/dL or urinary monoclonal protein \>= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60% * Absence of myeloma defining events or amyloidosis	* Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following * Hypercalcemia: serum calcium \> 0.25 mmol/L (\> 1 mg/dL) higher than the upper limit of normal or \> 2.75 mmol/L (\> 11 mg/dL) * Renal Insufficiency: creatinine clearance \< 40 ml/min or serum creatinine \> 2 mg/dL * Anemia: hemoglobin value \< 10 g/dL or 2 g/dL \< normal reference * Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\[F-18\] fluoro-D-glucose positron emission tomography CT (PET-CT) * Clonal bone marrow plasma cell percentage \>= 60% * Involved:uninvolved serum free light chain ratio \>= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom \[UK\]) * \> 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size) * Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies * Bisphosphonates are permitted * Radiotherapy is not permitted * Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted * Plasma cell leukemia * Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements

Inclusion Criteria

Exclusion Criteria

* Patients with monoclonal gammopathy of unknown significance. Both criteria must be met:
* Serum monoclonal protein \< 3 g/dL or urinary monoclonal protein \< 500 mg per 24 hours and clonal bone marrow plasma cells \< 10%
* Absence of myeloma defining events or amyloidosis
* Patients with smoldering multiple myeloma. Both criteria must be met:
* Serum monoclonal protein \>= 3 g/dL or urinary monoclonal protein \>= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%
* Absence of myeloma defining events or amyloidosis

* Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following
* Hypercalcemia: serum calcium \> 0.25 mmol/L (\> 1 mg/dL) higher than the upper limit of normal or \> 2.75 mmol/L (\> 11 mg/dL)
* Renal Insufficiency: creatinine clearance \< 40 ml/min or serum creatinine \> 2 mg/dL
* Anemia: hemoglobin value \< 10 g/dL or 2 g/dL \< normal reference
* Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\[F-18\] fluoro-D-glucose positron emission tomography CT (PET-CT)
* Clonal bone marrow plasma cell percentage \>= 60%
* Involved:uninvolved serum free light chain ratio \>= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom \[UK\])
* \> 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size)
* Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies
* Bisphosphonates are permitted
* Radiotherapy is not permitted
* Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted
* Plasma cell leukemia
* Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements

Contacts and Locations

Study Contact

Mei Huang

CONTACT

713-745-9901

mhuang3@mdanderson.org

Principal Investigator

Krin Patel, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Krin Patel, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-12-14

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2015-12-14

Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

Monoclonal Gammopathy of Undetermined Significance
Smoldering Plasma Cell Myeloma