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

April 28, 2006 updated by: Korean Multiple Myeloma Working Party

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Inchon, Korea, Republic of, 405-220
        • Recruiting
        • Gachon University Gil Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jae Hoon Lee, M.D.
        • Sub-Investigator:
          • Eun Mi Nam, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate of PAD induction Therapy

Secondary Outcome Measures

Outcome Measure
Response rate of PAD followed by Thal/Dex maintenance
Progression free survival and Overall survival of PAD/Thal-Dex.
To evaluate toxicities of PAD/Thal-Dex

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Multiple Myeloma Working Party

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Jae Hoon Lee, M.D., Korean Multiple Myeloma Working Party

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion

September 1, 2008

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 27, 2006

Last Update Submitted That Met QC Criteria

April 28, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMM55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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