Multiple myeloma
Conditions
Interventions
High dose dexamethasone therapy(one course):Dexamethasone 40mg/body po or iv(day 1-4,9-12,17-20) Bortezomib plus dexamethasone therapy(up to 4 courses):Bortezomib 1.3mg/m2 iv (day1,4,8,11).Dexamethas
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. Bortezomib plus dexamethasone therapy (at the second registration) 1. The efficacy evaluation after high dose dexamethasone therapy is under VGPR. 2. Good performance status (0-2). 3. Main Organ function is maintained. 4. Those who are evaluated to be able to survive more than 3 months.
Exclusion criteria
Exclusion criteria: 1.Peripheral neuropathy (>=grade 2) 2.Prior high dose dexamethasone therapy caused severe adverse events as follows; Liver dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, infection. 3.Patient was suspected pneumonia (Interstitial pneumonia) by high dose dexamethasone therapy. (Consult a respiratory specialist if necessary) 4.Those who are considered as inappropriate to register by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Probability of CR+VGPR after lenalidomide plus dexamethasone consolidation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Probability of CR+VGPR after lenalidomide maintenance therapy. 2.time to progression (TTP) 3.2-years progression free survival (PFS) 4.2-years overall survival (OS) 5.Incidence of adverse events | — |
Countries
Japan
Outcome results
None listed