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Trial Title:
TCD Followed by autoSCT for Newly Diagnosed MM Patients
NCT ID:
NCT00349115
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Thalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Thalidomide
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Je-Jung Lee
Address:
City:
Hwsun-eup, Hwasun-gun
Zip:
519-809
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yeo-Kyeoung Kim, MD, PhD
Phone:
82-61-379-7639
Email:
yeokim@chonnam.ac.kr
Investigator:
Last name:
Je-Jung Lee, MD, PhD
Email:
Principal Investigator
Start date:
June 2006
Completion date:
June 2008
Lead sponsor:
Agency:
Korean Multiple Myeloma Working Party
Agency class:
Other
Collaborator:
Agency:
Celgene Corporation
Agency class:
Industry
Source:
Korean Multiple Myeloma Working Party
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00349115
