Status:
COMPLETED
A Study of PAD Followed by Autologous Stem Cell Transplantation (ASCT) to Treat Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma. The primary objectives of this study is to assess the effect of bortezomib combination therapy (PAD regimen)...
Detailed Description
After providing written informed consent, subjects will be evaluated for eligibility during a 14-day screening period. Eligible subjects will receive 4 cycles PAD treatment prior to ASCT. Bisphosphona...
Eligibility Criteria
Inclusion
- Man or woman aged 18 to 65 years old;
- Subjects are newly diagnosed MM patients which are scheduled by the investigators to be treated with vincristine, adriamycin and dexamethasone standard therapy. Stage II/III (according to Durie and Salmon criteria) with skeletal involvement, such as bone pain, bone lytic lesions, diffuse osteoporosis or pathologic fractures;
- Life expectancy \> 3 months;
- Patient has measurable disease in which to capture response, defined as one or more of the following;
- Serum M-protein level \>10.0 g/L measured by serum protein electrophoresis or immunoglobulin electrophoresis; or
- Urinary M-protein excretion \> 1 g/24 hours; or
- Bone marrow plasmacytosis of \> 30% by bone marrow aspirate and/or biopsy; or
- Serum free light chains (by the Freelite test) \> 2 X the upper limit of normal (ULN), in the absence of renal failure.
- Performance status (PS) of ECOG ≤2.0, unless PS of 3-4 based solely on bone pain;
- Patients must have a Platelets count≥50×109 cells /L; Absolute neutrophil count (ANC)≥0.75×109 cells /L;
- Patients must have adequate hepatic function defined as Alanine transaminase(ALT) ≤ 2.5 × upper limit of normal(ULN); Aspartate transaminase (AST) ≤2.5×ULN; Total bilirubin ≤2×ULN;
- Patients must have adequate renal function defined as creatinine clearance \>30 ml /min;
- Subjects (or their legally acceptable representatives) must have signed a 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
- Non-secretory MM, unless the patient has measurable lesions on computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET);
- Peripheral neuropathy or neuropathy pain grade 2 or high as defined by National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) Version 3;
- Uncontrolled or severe cardiovascular disease, including myocardial infarction (MI ) within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis;
- History of allergy reaction attributable to compounds containing boron or mannitol;
- Any serious, active disease or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or the investigator's decision;
- Concurrent treatment with another investigational agent;
- Female subject who is pregnant or breast-feeding.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01852799
Start Date
December 1 2012
End Date
January 1 2017
Last Update
August 10 2018
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China