Multiple myeloma
Conditions
Interventions
Induction therapy 1-4 course: Bortezomib 1.3mg/m2 iv or sc (day1,4,8,11), dexamethasone 20mg/body iv or po (day 1,2,4,5,8,9, 11,12) PBSC harvest: Cyclophosphamide 1.5g/m2 div (day 1 , 2) H
Sponsors
Kanshinetsu Multiple Myeloma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). 2. Measureable M protein in serum or urine. 3. Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.) 4. Age from 20 to 65 years old. 5. Main Organ function is maintained 6. Those who are evaluated to be able to survive more than 3 months. 7. For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study. 8. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.
Exclusion criteria
Exclusion criteria: 1. Non-secretory MM and plasmacell leukemia. 2. Patients HIV-HBs-and HCV-positive 3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 4. Patients with a history of active malignancy during the past 5 years. 5. Patients with psychiatric disorders such as schizophrenia etc. 6. Pregnant women, pre-menopausal women, and lactating women. 7. History of hypersensitivity to mannitol or boron. 8. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary 9. Those who are considered as inappropriate to register by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate During consolidation and maintenance therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidents of adverse events During consolidation and maintenance therapy. 2. Probability of CR + VGPR after on Protocol | — |
Countries
Japan
Contacts
Public ContactShigeki Ito
Iwate Medical University School of Medicine Hematology and Oncology, Internal Medicine
Outcome results
None listed