multiple myeloma
Conditions
Interventions
1) VRD therapy (4X21-day cycles) Bortezomib 1.3mg/m2 i.v. or s.c. day1,8,15 Lenalidomide 25mg/body p.o. day1-14 Dexamethasone 40mg/body p.o. day1,8,15 2-1) Patients less than 50 years
t keep autologous stem cell Peripheral blood stem cell harvest mobilised by cyclophosphamide PBSC+
auto PBSCT followed by allo-HCT PBSC-
additional 0-4 cycles of VRD therapy follwed by lenalidomide (LEN) maintenance 2-2) Patients who don'
t fit 2-1) criteria 2-2-1) Patients who keep autologous stem cell Auto PBSCT followed by LEN maintenance 2-2-2) Patients who don'
auto PBSCT followed by LEN maintenance PBSC-
additional 4 cycles of VRD therapy follwed by LEN maintenance
Sponsors
Division of Hematology, Saitama Medical Center, Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been diagnosed with symptomatic multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG) 2) Patients who achieved at least partial response (PR) after auto PBSCT with or without consolidation therapy 3) 1 year has elapsed since auto PBSCT 4) Patients who meet the following re-treatment criteria 4-1) Patient with secretory myeloma resulted in clincal relapse 4-2) Patients with PR with monoclonal protein (M protein) levels of less or equal 0.5g/dL, resulted in either the clinical or significant paraprotein relapse 4-3) Patients relapsing from complete response (CR) or very good partial response (VGPR), resulted in either the clinical relapse or paraprotein relapse with 0.5g/dL or more M protein. 5) Patients with a measurable lesion or quantifiable M protein 6) Patients who are 20 to 65 years old at the time of enrollment in this study 7) Patients in good general condition (in ECOG Performance Status;0to2) 8) Pathents who have the following physical function 14 days before enrollment (N presents the upper limit of the institutional standard value) 8-1) SpO 2;94% or more (including indirect SpO2 measurement) 8-2) neutrophil count;1000/uL or more and platelet count;50000/uL or more 8-3) unnecessary for hemodialysis 8-4)Total bilirubin ;less ore equal 1.5XN, AST ;less or equal2.5XN and ALT ;less ore equal 2.5XN 9) Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method or male patients who agree to contraception by contraceptive operation or other appropriative method 10) Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Imformed Concent Form and Patient Inmormation
Exclusion criteria
Exclusion criteria: 1) Patients with a past history of allergy to the drug described in the protocol 2) Patients daiagnosed plasma cell neoplasm other than symptomatic multiple myeloma 3) Patients who cannnot be expected to live for more than 3 months 4) Patients who have had a complication of active double cancer* within the past 5 years *Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment, or lesions corresponding to intramucosal carcinoma (cervical carcinoma presenting in FIGO stage I) 5) HBs antigen, HCV antibody or HIV antibody positive patients 6) Patients with grade 2 or severer peripheral neuropathy or peripherl neurogenic pain (CTCAE v4.0) 7) Patients who have or suspected of having a serious active infection 8) Patients with serious mental disorders 9) Patients with serious pulmonary dysfunction 10) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality (e.g. a shadow of ground-glass opacity) on CT scan regardless of the presence or absence of symptoms (these patients should be enrolled after consultation with a respiratory specialist or radiologist) 11) Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment 12) Patients who are complicated by poorly controlled diabetes mellitus 13) Patients who are receiving hemodialysis 14) Patients who have serious liver dysfunction 15)Women who are or may be pregnant or are nursing 16) Other patients who are, in the opinion of the caring investigator, unfit for enrolloment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of achivement of CR or more after VRD therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Distribution of all response after treatment 2) The ratio of patients who complete the treatment protocol 3) 2 year progression free survival 4) 2 year overall suvival 5) safety | — |
Countries
Japan
Contacts
Public ContactKiriko Saito
Saitama Medical Center, Jichi Medical University Division of Hematology
Outcome results
None listed