Multiple myeloma
Conditions
Interventions
Bortezomib-based induction therapy followed by bortezomib maintenance therapy (1.3mg/m2) in every 2 weeks for one year.
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 more than 20 years old. 5. Main Organ function is maintained 6. Those who are evaluated to be able to survive more than 3 months. 7. 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. History of hypersensitivity to mannitol or boron. 7. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary 8. Those who are considered as inappropriate to register by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidents of adverse events during maintenance therapy | — |
Countries
Japan
Contacts
Public ContactAtsushi Isoda
NHO National Nishigunma Hospital Department of Internal Medicine
Outcome results
None listed