Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma

"Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~* Patients who demonstrate disease progression at any time will be taken off study.~* Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy.~* Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.~Maintenance therapy will consist of:~• Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)"

"Cycles 1-4~• Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle.~After completing 4 cycles:~* Patients who demonstrate disease progression at any time will be taken off study.~* Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy.~* Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy."

"Cycles 1-4 • Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.~After completing 4 cycles:~* Patients who demonstrate disease progression at any time will be taken off study.~* Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy.~* Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.~Maintenance therapy will consist of:~• Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of \< 40cc/min\*"