Bortezomib + Pegylated Liposomal Doxorubicin (Doxil) + Dexamethasone Followed by Thalidomide + Dexamethasone or Bortezomib + Thalidomide + Dexamethasone for Patients With Symptomatic Untreated High-Risk or Primary Resistant Multiple Myeloma
- Determine the efficacy and safety of bortezomib, pegylated doxorubicin hydrochloride
liposome, and dexamethasone followed by thalidomide and dexamethasone with or without
bortezomib in patients with symptomatic high-risk or primary resistant multiple
OUTLINE: Patients receive BDD comprising bortezomib IV on days 1, 4, 8, and 11; pegylated
doxorubicin hydrochloride liposome IV over 60-90 minutes on day 4; and oral dexamethasone on
day 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 3 courses in the
absence of disease progression or unacceptable toxicity.
Patients achieving response to BDD receive oral thalidomide on days 1-28 and oral
dexamethasone on days 1-4, 9-12, and 17-20. Treatment repeats every 28 days for 2 courses in
the absence of disease progression or unacceptable toxicity.
Patients experiencing stable or progressive disease on BDD receive oral thalidomide on days
1-28; oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, 12, and 17-21; and bortezomib IV on
days 1, 4, 8, and 11. Treatment repeats every 28 days for 2 courses in the absence of
disease progression or unacceptable toxicity.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Heather Landau, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|