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TCD Followed by autoSCT for Newly Diagnosed MM Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was:  Recruiting
Celgene Corporation
Information provided by:
Korean Multiple Myeloma Working Party Identifier:
First received: July 4, 2006
Last updated: May 5, 2008
Last verified: July 2006
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
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

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00349115

Contact: Je-Jung Lee, MD, PhD 82-61-379-7639
Contact: Yeo-Kyeoung Kim, MD, PhD 82-61-379-7639

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   
Principal Investigator: Je-Jung Lee, MD, PhD         
Sponsors and Collaborators
Korean Multiple Myeloma Working Party
Celgene Corporation
Principal Investigator: Je-Jung Lee, MD, PhD Chonnam National University Hospital
  More Information

Responsible Party: Korean Multiple Myeloma Working Party Identifier: NCT00349115     History of Changes
Other Study ID Numbers: KMM53
Study First Received: July 4, 2006
Last Updated: May 5, 2008

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
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 processed this record on September 20, 2017