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

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT01250808
• Other study ID #: 2008ZX09312-026
• Status: Available
• Phase: N/A
• First received: November 30, 2010
• Last updated: November 30, 2010

Study information

• Verified date: November 2010
• Source: Peking University
• Contact: xiaojun Huang
• Phone: +86-13701389625
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 at?stage 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.

Study Design

N/A

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
China	Institute of Hematology,Peking University	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China,