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

Launched by DANA-FARBER CANCER INSTITUTE · Oct 16, 2014

Keywords

ClinConnect Summary

This clinical trial is studying different types of blood cancers, including conditions like Monoclonal Gammopathy of Undetermined Significance (MGUS), Chronic Lymphocytic Leukemia (CLL), and early stages of Myelodysplastic Syndromes (MDS). Researchers want to understand the genetic changes that happen in these cancers, which may help them find better ways to treat or prevent these diseases in the future. To do this, they will analyze DNA from blood, bone marrow, and tissue samples from around 1,000 participants who currently have or are at risk of developing these conditions.

If you are at least 18 years old and have been diagnosed with a precursor blood cancer or have a condition that could lead to one, you may be eligible to participate. You won't have to undergo any extra tests outside of your usual medical care, but the study will ask for some additional samples, like a cheek scrape or blood test, to gather the information needed. This research is important because it aims to improve our understanding of blood cancers and how they can be better treated, ultimately benefiting patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.