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

Korean Multiple Myeloma Working Party

Status and phase

Unknown

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Dexamethasone

Drug: Thalidomide

Drug: Adriamycin

Drug: Velcade

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00319865

KMM55

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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