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N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information


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.

Type of Study:

Expanded Access

Study Design:

N/A

Authority:

China: Food and Drug Administration

Study ID:

2008ZX09312-026

NCT ID:

NCT01250808

Start Date:

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

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