A Phase I/II, Multicenter, Open-label, Dose-escalation Study of Bendamustine in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma
PRIMARY OBJECTIVES: I. To determine the MTD of bendamustine and lenalidomide in combination
with dexamethasone in subjects with MM in first or second relapse. (Phase I) II. To
evaluate the confirmed response rate of bendamustine in combination with lenalidomide and
dexamethasone in subjects with MM in first or second relapse. (Phase II) SECONDARY
OBJECTIVES: I. To evaluate the safety of bendamustine in combination with lenalidomide and
dexamethasone. (Phase I and II) II. To evaluate time-to-tumor-progression, progression-free
survival, duration of response, and overall survival. (Phase II) OUTLINE: This is a phase I
dose escalation study of bendamustine hydrochloride and lenalidomide followed by a phase II
study. Patients receive dexamethasone orally or IV on days 1, 8, 15, and 22; bendamustine
hydrochloride IV over 30 minutes on days 1 and 2; and oral lenalidomide once daily on days
1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving at least stable disease after 6 courses may
continue to receive lenalidomide and dexamethasone as above in the absence of disease
progression or unacceptable toxicity. Dexamethasone may be discontinued after 12 courses of
therapy at the treating investigator's discretion. After completion of study treatment,
patients are followed at 4 weeks and then periodically for up to 2 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of bendamustine hydrochloride and lenalidomide in combination with dexamethasone (phase I)
Yes
Shaji K. Kumar, M.D.
Study Chair
Mayo Clinic
United States: Food and Drug Administration
MMRC-020-021
NCT01049945
February 2010
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
City of Hope | Duarte, California 91010 |
University of Chicago | Chicago, Illinois 60637 |
Washington Universtiy School of Medicine | St. Louis, Missouri 63110 |