Multiple myeloma
Conditions
Interventions
1. VRD (Bortezomib 1.3mg/m2 s.c.
d1,4,8,11, lenalidomide 25mg/day p.o.
d1-14, dexamethasone 40mg/day
d1,4,8,11) therapy as induction therapy. 2. Mobilization using bortezomib,low-dose cyclophosphamide and G-CSF(cyclophosphamide 1g/m2 div
d1, bortezomib 1.3mg/m2 s.c.
d4,7, G-CSF
day4-) 3. High-dose melphalan plus auto-PBSCT(L-PAM 200mg/m2 div
d -2)
Sponsors
Ochanomizu Hematology Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient in symptomatic multiple myeloma or symptomatic nonsecretary myeloma according to IMWG criteria(2011). 2.Patient who has measurable disease. 3.Age >= 20 and <= 65 at time of registration. 4.ECOG-Performance Status(PS)is 0-2. 5.No interstitial pulmonary disorder is detected by X-ray or CT. 6.Patent who meets the following criteria; a) Liver function:T-Bil <= 1.5*ULN, AST or ALT <= 2.5*ULN; b) Bone marrow function ANC >= 1000/uL, Platelet >= 7.5*10^4/uL; c) Heart function: EF >= 55%; d) Pulmonary function: SpO2 >= 93%; e) Renal function: Ccr >= 30ml/min(Cockroft-Gault). 7.Untreated multiple myeloma. 8.Patient who can agree the registration for RevMate and keep its administrative procedure. 9.Patient who provided written consents for this study.
Exclusion criteria
Exclusion criteria: 1.Patient who has hypersensitivity to the study drugs. 2.Patient who has Grade >= 2 peripheral neuropathy (NCI CTCAE ver.4). 3.Patient who has sufficient heart disorders. 4.Uncontrolled active infection. 5.HBs antigen positive and/or HCV positive. 6.Active advanced-stage cancer. 7.Female patient who is pregnant and/or breastfeeding. 8.Active gastrointestinal bleeding. 9.Past history of renal transplantation. 10.Past history of pulmonary embolism, myocardial infarction and cerebral infarction. 11.Past history of deep vein thrombosis, administration of anticoagulants and/or antiplatelet drugs. 12.Uncontrolled diabetes mellitus. 13.Serious psychiatric illness 14.Patient who is judged to be medically unfit by his/her physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR/nCR rate for VRD therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS); Progression free survival (PFS); Overall response rate for VRD therapy; Overall response rate at 90 days after ASCT; Best response through the trial; Adverse event; CD34+ cell count after aphereses; Rate of reaching CD34+ cell count >= 2*10^6/kg; Therapy related quality of life. | — |
Countries
Japan
Contacts
Public ContactIkuyo Tsutsumi
National Hospital Organization Mito Medical Center Department of Hematology
Outcome results
None listed