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

NCT02269592 | Recruiting DMC

• 1 other identifier: 14-174
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

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

Keywords

MGUS; Smoldering Myeloma; Acute Myeloid Leukemia; Waldenstrom Macroglobulinemia; Monoclonal Gammopathy of Undermined Significance; Monoclonal B cell lymphocytosis; Smoldering Multiple Myeloma; Myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

• Identify molecular changes in cells of patients with precursor hematological malignancies

  10 years

Study Arms (1)

Specimen Collection

Patients' tumor tissue including bone marrow, blood, buccal swab or mouthwash, lymph node, urine or other specimens will be collected from patients who consent to the protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Known or Suspected Precursor Hematological Cancer

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.

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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (7)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute at St. Elizabeth's

Brighton, Massachusetts, 02135, United States

RECRUITING

Dana Farber Cancer Institute at Merrimack Valley

Methuen, Massachusetts, 01844, United States

RECRUITING

Dana Farber Cancer Institute at Milford Regional Medical Center

Milford, Massachusetts, 01757, United States

RECRUITING

Dana Farber Cancer Institute at South Shore

Weymouth, Massachusetts, 02190, United States

RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

RECRUITING

Dana Farber/New Hampshire Oncology-Hematology

Londonderry, New Hampshire, 03053, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, bone marrow, buccal swabs or mouthwashes, urine, lymph node biopsies, stool, discarded tissue or other specimens.

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance; Myelodysplastic Syndromes; Hematologic Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell; Smoldering Multiple Myeloma; Waldenstrom Macroglobulinemia; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Neoplasms by Site; Neoplasms; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Leukemia, Myeloid

Study Officials

• Irene Ghobrial, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Ghobrial, MD

CONTACT

617-632-4198; precursor@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 21, 2014
• Study Start: August 1, 2014
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (7)