Status:
COMPLETED
VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates
Lead Sponsor:
Korean Multiple Myeloma Working Party
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
65-75 years
Phase:
PHASE2
Brief Summary
Multiple Myeloma is a incurable disease. Recently developed targeted therapy gave new hope for the patients with multiple myeloma. Velcade in combination with other agents are currently in trials for ...
Detailed Description
The two effective and non-cross resistant regimens, VTD and MPT, will be applied sequentially to the patients with multiple myeloma who are not transplant candidates. This would be expected to result ...
Eligibility Criteria
Inclusion
- Newly diagnosed patients with overt multiple myeloma who are not candidates for HDT/SCT because of old age (\> 65) or presence of comorbid conditions likely to have a negative impact on tolerability of HDT/SCT. Sponsors review this conditions and approval is required.
- Presence of measurable disease : serum M-protein \> 1g/dL or urine M- protein \> 400mg/day
- Performance status £ ECOG 2
- Expected survival ³ 6 months
- Pretreatment clinical laboratory values meeting the following criteria within 14 days before enrollment platelet ≥ 100 x 109/L hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L) Prior RBC transfusion or recombinant human erythropoietin use is allowed) absolute neutrophil count (ANC) ≥ 1.0 x 109/L aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤ 3mg/dL corrected serum calcium \<14 mg/dL (\<3.5 mmol/L)
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion
- Smoldering or indolent myeloma
- History of allergic reaction attributable to compounds containing boron or mannitol
- Known hypersensitivity to thalidomide or dexamethasone
- Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
- 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
- Sepsis
- Pregnancy or breastfeeding
- Uncontrolled Diabetes Mellitus
- Recurrent DVT or pulmonary embolism
- Active ulcers detected by gastroscopy
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Receipt of extensive radiation therapy within 4 weeks
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00320476
Start Date
April 1 2006
End Date
February 1 2008
Last Update
May 6 2008
Active Locations (1)
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1
Gachon University Gil Hospital
Inchon, South Korea, 405-220