A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma
- To assess the progression-free survival at 1 year in patients with newly diagnosed
symptomatic multiple myeloma treated with lenalidomide alone or in combination with
dexamethasone added for disease progression or lack or partial response.
- To assess the response rate of this regimen in these patients.
- To assess the toxicity of this regimen in these patients.
- To examine the effect of lenalidomide alone on tumor specific immunity and global
parameters of immune function.
- To examine the effect of dexamethasone addition in patients requiring steroids.
- To correlate changes in parameters of immune response and measures of disease response.
- To examine the antiangiogenic activity of lenalidomide alone and in combination with
- To examine the effect of lenalidomide alone on tumor cell survival and proliferation.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every
28 days for up to 18 courses in the absence of second disease progression or unacceptable
toxicity. Beginning in course 4, patients experiencing stable or progressive disease also
receive concurrent oral dexamethasone once daily on days 1, 8, 15, and 22 and for all
Blood and bone marrow samples are collected periodically for pharmacological and correlative
studies. Samples are analyzed for parameters of immune activation, cell proliferation and
apoptosis, and circulating tumor cells and endothelial cells via flow cytometry; global
impact of therapy on immune cell subsets via immunophenotype analysis; and angiogenesis via
After completion of study therapy, patients are followed periodically for up to 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival Rate at 12 Months
PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization.
12 months from registration
Shaji K. Kumar, MD
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|