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NCT00319865 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00319865
Other study ID # KMM55
Secondary ID
Status Recruiting
Phase Phase 2
First received April 28, 2006
Last updated April 28, 2006
Start date November 2005
Est. completion date September 2008

Study information
Verified date April 2006
Source Korean Multiple Myeloma Working Party
Contact Jae Hoon Lee, M.D.
Phone 82-32-460-2186
Email jhlee@gilhospital.com
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 47
Est. completion date September 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Velcade

• Thalidomide

• Adriamycin

• Dexamethasone

Locations
Country Name City State
Korea, Republic of Gachon University Gil Hospital Inchon

Sponsors (2)
Lead Sponsor Collaborator
Korean Multiple Myeloma Working Party Celgene Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate of PAD induction Therapy
Secondary Response rate of PAD followed by Thal/Dex maintenance
Secondary Progression free survival and Overall survival of PAD/Thal-Dex.
Secondary To evaluate toxicities of PAD/Thal-Dex
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