PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma

PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma

Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.

Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone.

We desined prospective multicenter phase 2 study using these combination sequentially.

Inclusion Criteria:

• Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy.
• Presence of measureble disease : serum M-protein > 1g/dL or urine M-protein > 400mg/day
• Age < 75
• Performance status </= ECOG 2
• Expected survival > 6 months
• who signs the informed consent

Exclusion Criteria:

• known hypersensitivity to thalidomide or dexamethasone
• known refractoriness to thalidomide + dexamethasone
• Previous Velcade therapy
• Sepsis
• Woman in reproductive age
• Serum creatinine > 2 mg/dL ; 24 hour creatinine clearance < 30 ml/min; past medical history of kidney transplatation
• Peripheral neuropathy >/= grade 2
• Recurrent DVT or pulmonary embolism
• Cardiac ejection fraction <0.5 : Severe conduction disorder
• Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis
• Active ulcers in gastrofiberscope