Trial | NCT00319865  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    47
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.
Study Started
Nov 30
2005
Study Completion
Sep 30
2008
Last Update
Apr 27
2006
Estimate

Drug Velcade

Drug Thalidomide

Drug Adriamycin

Drug Dexamethasone

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 </= 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
No Results Posted