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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Peking University.
Recruitment status was  Available
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01250808
First received: November 30, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Multiple Myeloma
Drug: Bortezomib/Dexamethasone/Melphalan

Study Type: Expanded Access     What is Expanded Access?

Resource links provided by NLM:


Further study details as provided by Peking University:

Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250808

Contacts
Contact: xiaojun Huang +86-13701389625

Locations
China
Institute of Hematology,Peking University
Peking, China, 100044
Contact: jin Lu       lujinlj@163.com   
Sponsors and Collaborators
Peking University
  More Information

No publications provided

Responsible Party: Huang Xiaojun, Institute of Hematology, Peking University.
ClinicalTrials.gov Identifier: NCT01250808     History of Changes
Other Study ID Numbers: 2008ZX09312-026
Study First Received: November 30, 2010
Last Updated: November 30, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Melphalan
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014