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

Expanded access is currently available for this treatment.
Verified November 2010 by Peking University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01250808
First Posted: December 1, 2010
Last Update Posted: December 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
Peking University
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Huang Xiaojun, Institute of Hematology, Peking University.
ClinicalTrials.gov Identifier: NCT01250808     History of Changes
Other Study ID Numbers: 2008ZX09312-026
First Submitted: November 30, 2010
First Posted: December 1, 2010
Last Update Posted: December 1, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
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
Dexamethasone acetate
Dexamethasone
Bortezomib
Melphalan
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents