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Observational Study of Precursor Blood Cancers

This observational study aims to understand how certain precursor blood cancers, like Monoclonal Gammopathy of Undetermined Significance (MGUS), smoldering myeloma, and early Myelodysplastic Syndromes (MDS), progress. Researchers are looking for molecular changes in cells that might lead to more serious blood cancers. They will analyze existing tissue samples, blood, or other body fluids from patients already diagnosed with these conditions. The goal is to identify these molecular changes over 10 years and link them to how the diseases behave clinically. This study is for adults aged 18 and older who have a known or suspected precursor hematological (blood) cancer. There is no specific intervention being tested; instead, the study focuses on understanding the disease itself.

Study design
This is an observational study planning to enroll 10,000 participants. It is not testing a specific drug or treatment.
What's involved
You may be asked to provide one additional sample of blood (a few teaspoons), a gentle mouth swab, or a skin sample. Otherwise, no additional procedures are generally required beyond your usual clinical care.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to identify molecular changes over a period of 10 years.

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NCT02269592

Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome

Recruiting
Not specifiedAges 18+Observational
Dana-Farber Cancer Institute
~10,000 participants
Updated 2026-05-07 on ClinicalTrials.gov

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identify molecular changes in cells of patients with precursor hematological malignancies
Measured over 10 years

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS)
Myelodysplastic Syndromes
Hematological Malignancies
B-cell Malignancy, Low-grade
Myelodysplastic Syndrome With Low-grade Lesions
IgG Monoclonal Gammopathy of Uncertain Significance
Smoldering Multiple Myeloma
Waldenstrom Macroglobulinemia

Explore related trials

Hematologic NeoplasmIdiopathic Cytopenia of Undetermined SignificanceLow Grade LymphomaMonoclonal B-Cell LymphocytosisMonoclonal Gammopathy of Undetermined SignificanceMyelodysplastic SyndromeSmoldering Multiple MyelomaWaldenstrom Macroglobulinemia

Where it's being run

7 sites across 3 states
Massachusetts5
Michigan1
New Hampshire1

Study leadership

  • Irene Ghobrial, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Irene Ghobrial, MD
[email protected]
617-632-4198
Email the study team

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Eligibility criteria

Inclusion

Patients with Known or Suspected Precursor Hematological Cancer
Including the following subgroups of diseases:
Early MDS, including pathologically-confirmed MDS (IPSS Low/Int-1; IPSS-R Very Low/Low) and idiopathic cytopenias of undetermined significance (ICUS);
Asymptomatic Multiple Myeloma and Waldenstrom Macroglobulinemia such as monoclonal gammopathy of undermined significance (MGUS) or Smoldering Multiple Myeloma (SMM or SWM);
Monoclonal B cell lymphocytosis (MBL);
Early stage asymptomatic low-grade lymphomas; or
Other precursor conditions or clonal genetic abnormalities of the blood/bone marrow that do not meet criteria for symptomatic hematological malignancy, or patients exposed to prior chemotherapies (e. g., alkylating agents, platinum derivatives, taxanes, topo-2 inhibitors, anti-metabolites, systemic radioisotopes).
Patients must be at least 18 years of age to participate in this research.
Inclusion of Women and Minorities -- In accordance with NIH guidelines, women and members of minority groups and their subpopulations will be included in this protocol.

Exclusion

Patients with Known or Suspected Precursor Hematological Cancer are NOT EXCLUDED
Evidence of symptomatic or active hematological malignancy. Patients enrolled on clinical trials for precursor diseases are NOT excluded from this study.

What this trial measures

  • Identify molecular changes in cells of patients with precursor hematological malignancies10 years