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
Celgene Corporation
Information provided by:
Korean Multiple Myeloma Working Party Identifier:
First received: April 28, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
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.


Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00319865

Contact: Jae Hoon Lee, M.D. 82-32-460-2186
Contact: Hee Keun Kang, R.N. 82-32-460-3655

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

Additional Information:
No publications provided 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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Liposomal doxorubicin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal processed this record on November 25, 2015