TCD Followed by autoSCT for Newly Diagnosed MM Patients
Recruitment status was Recruiting
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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 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: | Induction Therapy With TCD Regimen (Thalidomide, Cyclophosphamide, Dexamethasone) Followed by Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients |
- Response rate of TCD induction Therapy
- 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 |
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 |
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| 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 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Korean Multiple Myeloma Working Party |
| ClinicalTrials.gov Identifier: | NCT00349115 History of Changes |
| Other Study ID Numbers: | KMM53 |
| Study First Received: | July 4, 2006 |
| Last Updated: | May 5, 2008 |
| Health Authority: | Singapore: Domain Specific Review Boards |
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 Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013