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

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ClinicalTrials.gov Identifier: NCT00319865
Recruitment Status : Unknown
Verified April 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was:  Recruiting
First Posted : April 27, 2006
Last Update Posted : April 27, 2006
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Korean Multiple Myeloma Working Party

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Velcade Drug: Thalidomide Drug: Adriamycin Drug: Dexamethasone Phase 2

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  (Clinical Trial)
Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Response rate of PAD induction Therapy

Secondary Outcome Measures :
  1. Response rate of PAD followed by Thal/Dex maintenance
  2. Progression free survival and Overall survival of PAD/Thal-Dex.
  3. To evaluate toxicities of PAD/Thal-Dex


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00319865     History of Changes
Other Study ID Numbers: KMM55
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: April 27, 2006
Last Verified: April 2006

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
Liposomal doxorubicin
Thalidomide
Bortezomib
Doxorubicin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists