multiple myeloma
Conditions
Interventions
Induction (4x21-day cycles) Bortezomib 1.3mg/m2iv day1,4,8,11 Dexamethazone 20mg/day p.o. day 1,2,4,5,8,9,11,12 Filgrastim 200ug/m2/day sc day1,2,3,4,(5),(6) Apheresis day4,(5),(6) High-dose
Sponsors
Division of Hematology, Saitama Medical Center, Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria; 1. The patients who meet the following inclusion criteria will be enrolled in this study. 2. Patients who have been diagnosed with symptomatic multiple myeloma according to the diagnostic criteria (Appendix 1) of the International Myeloma Working Group (IMWG) 3. Untreated patients without a history of pretreatment excluding local radiotherapy from pretreatment - Patients with a lesion measurable in the evaluation of efficacy -Patients with a quantifiable serum M protein level (generally serum M protein level >= 1.0 g/dL in terms of IgG per >=0.5 g/dL in terms of IgA) - Patients with a urine M protein level quantifiable by electrophoresis (generally urine M protein level >=0.2 g/day) 4. Patients who are 20 to 65 years old at the time of enrollment in this study 5. Patients in good general condition (in performance status (PS) 0 to 2) (Appendix 2) 6. Patients who have the following laboratory values 14 days before provisional enrollment (N presents the upper limit of the institutional standard value) 7. 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 (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method, 8. 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 Informed Consent Form and Patient Information.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Patients with a past history of allergy to the drug described in the protocol 2. Patients diagnosed with smoldering myeloma or MGUS 3. Patients who cannot 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 (excluding 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 peripheral neurogenic pain (Ctcae v3.0 JCOG/JSCO ver.) 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 (high-resolution CT) regardless of the presence or absence of symptoms (these patients should be enrolled after consultation with a respiratory specialist or a 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 on account of nephropathy other than the underlying disease 14. Women who are or may be pregnant or are nursing 15. Other patients who are, in the opinion of the caring investigator, unfit for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of achivement of CR or more (sCR, CR) 100 days after autologous stem cell transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Distribution of all response after treatment, The ratio of patients who complete the treatment protocol 3 year progression free survival 3 year overall survival safety | — |
Countries
Japan
Contacts
Public ContactKiriko Terasako
Saitama Medical Center, Jichi Medical Univerisity Division of Hematology
Outcome results
None listed