Multiple myeloma
Conditions
Interventions
Bortezomib(1.3m/m2,days 1,8,15,22, sq),Melphalan(6mg/m2,days 1-4) and prednisone(40mg/m2,days 1-4) administered for four 35-day cycles as induction therapy,followed by Bortezomib(1.3mg/m2,day1,15, sq)
Sponsors
Saitama Medical Center, Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG) (2)untreated patients without a history of pretreatment, excluding local radiotherapy from pretreatment (3)untreated multiple myeloma patients who diagnosed ineligible for autologous stem cell transplantation at induction therapy (4)aged more than 20 years old (5)performance status:0-2,or 3 due to osteolytic lesions alone (6)coexisting conditions are eligible as follows: neutrophil count; more than 1,000/mm3,platelet count; more than 50,000/mm3,hemoglobin count; more than 7.0g/dL (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: (1)Patients with a past history of allergy to the drug described in the protocol (2)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) (3)HBs antigen,or HCV antibody positive patients (4) serious mental disorders such as schizophrenia (5) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality on X-ray scan regardless of the presence or absence of symptoms (6) Patients who have or suspected of having a serious active infection (7) Patients with serious pulmonary dysfunction (8) Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment (9)The serum AST value and ALT value is more than 2.5 times from a facilities upper limit (10)The serum total bilirubin value is more than 2.0 times from a facilities upper limit (11)Patients with grade 2 or severer peripheral neuropathy (12)Women who are or may be pregnant (13)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidents of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Best response rate,Time to progression | — |
Countries
Japan
Contacts
Public ContactKenshi Suzuki
Japanese Red Cross Medical Center Department of Hematology
Outcome results
None listed