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TCD Followed by autoSCT for Newly Diagnosed MM Patients
This study is currently recruiting participants.
Verified by Korean Multiple Myeloma Working Party, July 2006
First Received: July 4, 2006   Last Updated: May 5, 2008   History of Changes
Sponsors and Collaborators: Korean Multiple Myeloma Working Party
Pharmion, Celgene
Information provided by: Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier: NCT00349115
  Purpose

Multiple Myeloma is a incurable disease. Thalidomide in combination with other agents are currently in trials for the newly diagnosed patients, we designed treatment of TCD, followed by high dose chemotherapy with autologous stem cell transplantation and TD maintenance therapy for the patients with newly diagnosed multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Induction Therapy With TCD Regimen (Thalidomide, Cyclophosphamide, Dexamethasone) Followed by Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate of TCD induction Therapy

Secondary Outcome Measures:
  • Progression free survival and Overall survival of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance
  • To evaluate toxicities of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance.

Estimated Enrollment: 43
Study Start Date: June 2006
Estimated Study Completion Date: June 2008
Detailed Description:

Phase II clinical trial for the patients with newly diagnosed. TCD (thalidomide, cyclophosphamide and dexamethasone) will be applied for the patients as an induction chemotherapy, followed by high dose chemotherpy and autologous stem cell transplantation. Afterthen, they will receive TD (thalidomide and dexamethasone) maintenance therapy for one year.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Newly diagnosed multiple myeloma in aged between 18 and 75 years old with following mesurable leisons: (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day) -

Exclusion Criteria:

- 1. Smoldering or indolent myeloma 2. ECOG performance status > 3 point 3. Known hypersensitivity to cyclphosphamide, thalidomide or dexamethasone 4. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 5. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg 6. Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal) 7. Creatinine cliearance < 20 ml/min 8. Corrected serum calcium ≥ 14 mg/dL 9. Sepsis or current active infection 10. Pregnancy or breast feeding 11. Uncontrolled Diabetes Mellitus 12. Previous history of Recurrent DVT or pulmonary embolism 13. Active ulcers detected by gastroscopy 14. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

15. Receipt of extensive radiation therapy within 4 weeks

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349115

Contacts
Contact: Je-Jung Lee, MD, PhD 82-61-379-7639 yeokim@chonnam.ac.kr
Contact: Yeo-Kyeoung Kim, MD, PhD 82-61-379-7639 yeokim@chonnam.ac.kr

Locations
Korea, Republic of, Jeollanam-do
Je-Jung Lee Recruiting
Hwsun-eup, Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
Contact: Yeo-Kyeoung Kim, MD, PhD     82-61-379-7639     yeokim@chonnam.ac.kr    
Principal Investigator: Je-Jung Lee, MD, PhD            
Sponsors and Collaborators
Korean Multiple Myeloma Working Party
Pharmion, Celgene
Investigators
Principal Investigator: Je-Jung Lee, MD, PhD Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: ( Korean Multiple Myeloma Working Party )
Study ID Numbers: KMM53
Study First Received: July 4, 2006
Last Updated: May 5, 2008
ClinicalTrials.gov Identifier: NCT00349115     History of Changes
Health Authority: Singapore: Domain Specific Review Boards

Study placed in the following topic categories:
Dexamethasone
Anti-Infective Agents
Immunoproliferative Disorders
Immunologic Factors
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Angiogenesis Inhibitors
Immunosuppressive Agents
Multiple Myeloma
Anti-Bacterial Agents
Hemorrhagic Disorders
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Growth Substances
Vascular Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Lymphoproliferative Disorders
Neoplasms, Plasma Cell
Leprostatic Agents

ClinicalTrials.gov processed this record on September 11, 2009