TCD Followed by autoSCT for Newly Diagnosed MM Patients

Multiple Myeloma Clinical Trial

Official title:

Induction Therapy With TCD Regimen (Thalidomide, Cyclophosphamide, Dexamethasone) Followed by Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00349115
• Other study ID #: KMM53
• Status: Recruiting
• Phase: Phase 2
• First received: July 4, 2006
• Last updated: May 5, 2008
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2006
• Source: Korean Multiple Myeloma Working Party
• Contact: Je-Jung Lee, MD, PhD
• Phone: 82-61-379-7639
• Email: yeokim[@]chonnam.ac.kr
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Thalidomide

Locations

Country	Name	City	State
Korea, Republic of	Je-Jung Lee	Hwsun-eup, Hwasun-gun	Jeollanam-do

Sponsors (2)

Lead Sponsor	Collaborator
Korean Multiple Myeloma Working Party	Celgene Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of TCD induction Therapy
Secondary	Progression free survival and Overall survival of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance
Secondary	To evaluate toxicities of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance.