TCD Followed by autoSCT for Newly Diagnosed MM Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier:
NCT00349115
First received: July 4, 2006
Last updated: May 5, 2008
Last verified: July 2006
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
  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 October 19, 2014