Technology Platform and System Construction of Clinical Evaluation Studies on New Drugs of Hematological Malignancy

Study Overview
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Brief Summary
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Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The previous study pointed out that the dosage and course of Bortezomib including the dose of concomitant drugs used to treatment MM patients did not get the preferred treatment program, so we are going to determine the optimal doses and course of Bortezomib through the prospective, multicenter clinical trial and evaluate the efficiency and safety of different program.

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib/Dexamethasone/Melphalan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obtain informed consent form (ICF) signed by patients or its relative. Patients newly diagnosed multiple myeloma (MM). (Not include patients with multiple solitary extramedullary plasmacytoma and those atⅠstage of Durie-Salmon staging system) Measurable serum protein: IgG type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgA type of MM: serum M-protein≥0.5g/dl or urine M-protein≥200mg/24h. IgM type of MM: (IgM M-protein and osteolytic lesion showed in X-ray):serum protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgD type of MM: serum M-protein≥0.05g/dl or urine M-protein≥200mg/24h. Light chain type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. Physical score 0 2 grade(WHO standard), and able to comply with the visit time and protocol requirements. Exclusion Criteria: Diagnosed with relapsed multiple myeloma. Any serious diseases which may lead patients suffer from unaccepted risk. Female patients who is pregnant or breast-feeding. Histories of other malignant tumors other than MM, except those patients whose disease have been cured for at least 3 years. Exception: basal-cell carcinoma, squamous cell carcinoma, carcinoma in situ of uterine cervix, breast carcinoma in situ,occasionally prostatic cancer histological discovery(at stage T1a or T1B defined as TNM classification). Not be able to understand or comply with the investigate protocol. Patients with grade 2 or higher peripheral neuropathy before treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bortezomib/Dexamethasone/Melphalan|Induction therapy: The treatment will continue for 3-4 cycles and each cycle will be last 21 days. Bortezomib 1.3mg/m2, twice weekly for two weeks (days 1, 4, 8, and 11) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle. Bortezomib 1.0mg/m2, twice weekly for two weeks (days 1, 4, 8, and 11) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle. Bortezomib 1.6mg/m2, once weekly for two weeks (days 1, 8) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle and on days 9-12 of the first and second cycles. ASCT therapy: Melphalan 200mg/m2 +Bortezomib 1.0mg/m2 for four times. Melphalan 200mg/m2 +Bortezomib 1.0mg/m2 for two times.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |