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

• Status: Unknown status
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korean Multiple Myeloma Working Party
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Thalidomide

Criteria

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
• 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