The evaluation of the efficacy and safety on Bortezomib and Dexamethasone (BD therapy) using auto-PBSCT treatment after Vincristine,Doxorubicin and examethasone (VAD treatment) registanced multiple myeloma patients.(JMSG-0901)

UMIN ID: UMIN000002285

Registered date:03/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Multiple myeloma.
• Date of first enrollment: 2009/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 1) The standard remission introduction treatment (Vincristine, Doxorubicin, and Dexamethasone (short VAD treatment) is executed by two courses. 2) Bortezomib and Dexamethasone (BD) treatment is executed by 2-4 courses. 3) Auto peripheral blood stem cell transplant.(Auto-PBSCT)

Outcome(s)

• Primary Outcome: The ratio of complete remission (SCR, CR) after 100 days auto-PBSCT treatment.
• Secondary Outcome: 1. complete remission ratio after BD treatment (CR or PR). 2. All taking effect ratio after 100 days of private blood formation stem cell transplant (Auto PBSCT) (CR and PR). 3. Periods of progression free survival. (PFS) 4. Overall survival for 3 years. (3y OS) 5. Safety.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) There is a previous history of hypersensitivity for, Bortezomib the Doxorubicin, the Dexamethasone, the mannitol or boron. 2) Myeloma and plasma cell leukemia of nonsecreted form. 3) Case from whom amalgamation of nuclear power plant AL amyloidosis is doubted. 4) Case who has peripheral neuropathy of Grade 2 or more. 5) Patient of HIV antibody positivity, hepatitis B surface antigen positivity, and HCV antibody positivity. 6) There are a defective liver dysfunction to control, a renal dysfunction, a depressed ventricular function, a pulmonic impairment, a diabetic, high blood pressure, and an infectious disease. 7) It is briskness and a double cancer of the progress period (Simultaneity repetition cancer and a healthy period are the cancer of repetition of different time within five years. However, the considerable Carcinoma in Situ change to a morbid state in the neck of womb, the stomach, and the large intestine judged to be a recovery by the limited part treatment is not included in the double cancer of briskness). 8) A certain patient of serious illness such as schizophrenia. mental trouble. 9) Case pregnant woman and possibility getting pregnant and suckling during examination period. 10) The case (Consult if necessary with a special doctor such as respiratory organs) who admits an abnormal shadow of the quality (state of frosted glass and line shadow) among both sides on chest CT (high resolution CT) regardless of the presence of the case who has the lungs flame (interstitial pneumonia) and the pulmonary fibrosis in the clinical finding or the symptom. 11) Additionally, case who judged doctor in charge targets and it is improper.

Related Information

• Primary Sponsor: Japanese Society of Myeloma
• Source(s) of Monetary Support: None