Multiple myeloma
Conditions
Interventions
Induction therapy 1st course: Bortezomib 1.3mg/m2 iv (day1,4,8,11), cyclophosphamide 500mg/m2 iv (day1, 8), dexamethasone 40mg/body po (day 1,4,8, 11) 2nd and 3rd courses: Bortezomib 1.3mg/m2 iv (
Sponsors
Japan Study Group for Cell Therapy and Transplantation
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-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 |
|---|---|
| Probability of CR after consolidation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Probability of CR + sCR after induction therapy. 2. Probability of CR + sCR after autologous stem cell transplantation. 3. Probability of sCR after consolidation therapy. 4. Probability of CR + sCR after maintenance therapy. 5. 2-years progression free survival (PFS) 6. 2-years overall survival (OS) 7. Time to progression (TTP) 8. Incidence of adverse events. 9. Probability of molecular remission (mCR) after autologous stem cell transplantation, consolidation therapy, and maintenance therapy. 10. Detection of minimal residual disease (MRD) in autologous grafts. | — |
Countries
Japan
Outcome results
None listed