Study comparing lenalidomide vs observation in subjects with high-risk multiple myeloma

What we are studying

The purpose of this study is to find out what effects (good and bad) the use of the drug lenalidomide has on study participants and their multiple myeloma, and to compare this with patients that receive no therapy. Currently, the accepted treatment for asymptomatic myeloma is to receive no therapy. However, not all patients with asymptomatic (smoldering) myeloma have the same outcome. There are 3 groups of patients as identified by the Mayo clinic group that have different predicted outcomes. Because the 3 groups can have very long delays between the identification of smoldering myeloma and the requirement for treatment, not all patients are eligible for this study. Only patients with ”high-risk” smoldering myeloma are considered eligible for this study as these are all patients whose risk of developing myeloma that requires therapy is the highest. Lenalidomide is a drug that has shown benefit and is approved for use in patients whose myeloma has been resistant to other therapies. The mechanism by which lenalidomide works in myeloma is still unclear, but it is felt that the drug works by making the study participant's own immune system (the body’s natural defense against disease) work better against the myeloma cells. It may also have additional direct effects on the myeloma cells. Though lenalidomide is an approved drug for symptomatic myeloma and myelodysplastic syndrome (diseases of blood and bone), it is experimental for the asymptomatic patients who will participate in this study.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • Hispanic or Latino
  • Ages 18 - 80

Eligibility Criteria

  • No prior treatment for myeloma

What is involved

  • Study participants will be randomized to receive either lenalidomide or observation. All study participants will be asked to complete quality of life questionnaires at various times during their study participation.



Contact Information

Study Coordinator
Jennifer Thomas
[email protected]

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