TCD Followed by autoSCT for Newly Diagnosed MM Patients

NCT00349115 | Unknown Phase 2

• 1 other identifier: KMM53
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Response rate of TCD induction Therapy

Secondary Outcomes (2)

• 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.

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- 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.
• \. Receipt of extensive radiation therapy within 4 weeks

Sponsors & Collaborators

• Korean Multiple Myeloma Working Party: lead
• Celgene Corporation: collaborator

Study Sites (1)

Je-Jung Lee

Hwsun-eup, Hwasun-gun, Jeollanam-do, 519-809, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Je-Jung Lee, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Je-Jung Lee, MD, PhD

CONTACT

82-61-379-7639; yeokim@chonnam.ac.kr

Yeo-Kyeoung Kim, MD, PhD

CONTACT

82-61-379-7639; yeokim@chonnam.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2006
• First Posted: July 6, 2006
• Study Start: June 1, 2006
• Study Completion: June 1, 2008
• Last Updated: May 6, 2008

Record last verified: 2006-07

Locations

KR (1)