Phase II Study of Pegylated Liposomal Doxorubicin (Doxil®), Low Frequency Dexamethasone and Revlimid® (Dd-R) in Newly Diagnosed Multiple Myeloma
Induction Phase:
Newly diagnosed multiple myeloma patients with active disease 20, will be treated with Dd-R
as outlined below:
All patients will also receive Levaquin 500 mg by mouth (PO) every day (QD)(or if allergic
receive amoxicillin 250 mg PO twice a day [BID]), acyclovir 400 mg PO BID or Valacyclovir
500mg BID and aspirin 81 mg PO QD daily while receiving Dd-R. Aspirin will continue through
maintenance. For patients who cannot tolerate aspirin, low molecular weight heparin or
therapeutic doses of coumadin may be used in place of aspirin.
- Doxil® 30mg/m2 on day # 1 to be repeated every 28 days
- Dexamethasone 40mg per day for 4 days (days 1-4) every 28 days
- Revlimid® 25mg po daily on days 1-21, followed by 7 days of no therapy, repeated every
28 days.
Maintenance Therapy:
Patients who complete the induction regimen or those who complete at least 2 cycles of the
induction regimen and not showing evidence of progressive disease but cannot tolerate any
further chemotherapy could be started on maintenance therapy as follows:
- Revlimid® 15mg or 25mg* po daily on days 1-21, followed by 7 days of no therapy,
repeated every 28 days.
- Dexamethasone 40mg per day for 4 days (days 1-4) every 28 days
All participants will also receive aspirin 81 mg PO QD daily while receiving maintenance.
For patients who cannot tolerate aspirin, low molecular weight heparin or therapeutic doses
of coumadin may be used in place of aspirin.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response (OR)
Overall response rate to induction Dd-R as assessed using International Myeloma Working Group Response Definitions
24 Months
No
Rachid Baz, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
MCC-14986
NCT00617591
January 2008
April 2013
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |