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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier:
NCT00319865
First received: April 28, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Velcade
Drug: Thalidomide
Drug: Adriamycin
Drug: Dexamethasone
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Korean Multiple Myeloma Working Party:

Primary Outcome Measures:
  • Response rate of PAD induction Therapy

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 47
Study Start Date: November 2005
Estimated Study Completion Date: September 2008
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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319865

Contacts
Contact: Jae Hoon Lee, M.D. 82-32-460-2186 jhlee@gilhospital.com
Contact: Hee Keun Kang, R.N. 82-32-460-3655 happy@gilhospital.com

Locations
Korea, Republic of
Gachon University Gil Hospital Recruiting
Inchon, Korea, Republic of, 405-220
Contact: Jae Hoon Lee, M.D.    82-32-460-2186    jhlee@gilhoospital.com   
Contact: Hee Keun Kang, R.N.    82-32-460-3655    happy@gilhospital.com   
Principal Investigator: Jae Hoon Lee, M.D.         
Sub-Investigator: Eun Mi Nam, M.D.         
Sponsors and Collaborators
Korean Multiple Myeloma Working Party
Celgene Corporation
Investigators
Principal Investigator: Jae Hoon Lee, M.D. Korean Multiple Myeloma Working Party
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00319865     History of Changes
Other Study ID Numbers: KMM55
Study First Received: April 28, 2006
Last Updated: April 28, 2006
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Korean Multiple Myeloma Working Party:
Multiple Myeloma Relapsed

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Doxorubicin
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 15, 2014