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

Recruiting now

Conditions studied: 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

In brief

Blood cancers occur when the molecules that control normal cell growth are damaged. Many of these changes can be detected by directly examining parts of the cancer or cells in blood. Several alterations that occur repeatedly in certain types of blood cancers have already been identified, and these discoveries have led to the development of new drugs that target those alterations. More remain to be discovered. Some of these abnormalities include alterations in genes. Genes are the part of cells that contain the instructions which tell the investigators bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are composed of DNA letters that spell out these instructions. Studies of the DNA molecules that make up the genes are called "molecular" analyses. Molecular analyses are ways of reading the DNA letters to identify errors in genes that may contribute to an increased risk of cancer or to the behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur in the genes that are passed from parent to child. This research study will examine both kinds of genes. The best way to find these genes is to study large numbers of people. The investigators expect that as many 1000 individuals will enroll in this study. This research study is trying to help doctors and scientists understand why cancer occurs and to develop ways to better treat and prevent it. To participate in this study the participant must have cancer now, had it in the past, or are at risk of developing cancer. The participant will not undergo tests or procedures that are not required as part of their routine clinical care. The investigators will ask the participant to provide an additional sample from tissue that is obtained for their clinical care including blood, bone marrow, or tissue sample. The investigators will also ask for a gentle scrape of the inside of their cheek, mouthwash or a skin sample to obtain their germline DNA

Key facts

Study ID: NCT02269592
Run by: Dana-Farber Cancer Institute
People needed: 10000
Starts: 2014-08-01
Expected to finish: 2030-09-01
Last updated by the study team: 2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
Dana Farber Cancer Institute at St. Elizabeth's — Brighton, Massachusetts, United States (enrolling)
Dana Farber Cancer Institute at Merrimack Valley — Methuen, Massachusetts, United States (enrolling)
Dana Farber Cancer Institute at Milford Regional Medical Center — Milford, Massachusetts, United States (enrolling)
Dana Farber Cancer Institute at South Shore — Weymouth, Massachusetts, United States (enrolling)
West Michigan Cancer Center — Kalamazoo, Michigan, United States (enrolling)
Dana Farber/New Hampshire Oncology-Hematology — Londonderry, New Hampshire, United States (enrolling)

Full record on ClinicalTrials.gov

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