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TCD Followed by autoSCT for Newly Diagnosed MM Patients

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ClinicalTrials.gov Identifier: NCT00349115
Recruitment Status : Unknown
Verified July 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was:  Recruiting
First Posted : July 6, 2006
Last Update Posted : May 6, 2008
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Korean Multiple Myeloma Working Party

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Thalidomide Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Therapy With TCD Regimen (Thalidomide, Cyclophosphamide, Dexamethasone) Followed by Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
Study Start Date : June 2006
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide




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

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


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): 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
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
Celgene Corporation
Investigators
Principal Investigator: Je-Jung Lee, MD, PhD Chonnam National University Hospital

Responsible Party: Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier: NCT00349115     History of Changes
Other Study ID Numbers: KMM53
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: July 2006

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
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents