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

Primary Purpose

Multiple Myeloma

Status

Available

Phase

Locations

China

Study Type

Expanded Access

Intervention

Bortezomib/Dexamethasone/Melphalan

About this trial

This is an expanded access trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

Institute of Hematology,Peking University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01250808

First Posted

November 30, 2010

Last Updated

November 30, 2010

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01250808

Brief Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Peking University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Bortezomib/Dexamethasone/Melphalan

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xiaojun Huang

Phone

+86-13701389625

Facility Information:

Facility Name

Institute of Hematology,Peking University

City

Peking

ZIP/Postal Code

100044

Country

China

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jin Lu

lujinlj@163.com

12. IPD Sharing Statement

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

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