TCD Followed by autoSCT for Newly Diagnosed MM Patients

Phase 2

• Conditions: Multiple Myeloma

• Registration Number: NCT00349115
• Lead Sponsor: Korean Multiple Myeloma Working Party

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.

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.

Study Timeline

• Study Start: 2006-06
• Status Verified: 2006-07
• Study First Submitted: 2006-07-04
• Study First Submitted QC: 2006-07-04
• Study First Posted: 2006-07-06
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-06
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate of TCD induction Therapy

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Je-Jung Lee; 🇰🇷 Hwsun-eup, Hwasun-gun, Jeollanam-do, Korea, Republic of