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Sponsors and Collaborators: |
Korean Multiple Myeloma Working Party Pharmion, Celgene |
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Information provided by: | Korean Multiple Myeloma Working Party |
ClinicalTrials.gov Identifier: | NCT00349115 |
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 |
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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 |
Estimated Enrollment: | 43 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2008 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 |
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 |
Principal Investigator: | Je-Jung Lee, MD, PhD | Chonnam National University Hospital |
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 |
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 |
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 |