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

Peking University

Status

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib/Dexamethasone/Melphalan

Study type: Expanded Access

Funder types: Other

Identifiers

NCT01250808

2008ZX09312-026

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Obtain informed consent form (ICF) signed by patients or its relative.

2. Patients newly diagnosed multiple myeloma (MM). (Not include patients with multiple solitary extramedullary plasmacytoma and those atⅠstage of Durie-Salmon staging system)

3. 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.

4. Physical score 0~2 grade(WHO standard), and able to comply with the visit time and protocol requirements.

Exclusion criteria

1. Diagnosed with relapsed multiple myeloma.
2. Any serious diseases which may lead patients suffer from unaccepted risk.
3. Female patients who is pregnant or breast-feeding.
4. 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).
5. Not be able to understand or comply with the investigate protocol.
6. Patients with grade 2 or higher peripheral neuropathy before treatment.