None listed
Conditions
Interventions
Drug : The subjects will be administered bortezomib with a dose of 1.3mg/m2/day on the day 1, 8 and 15 among 1 cycle (which was consists of 28 days). Bortezomib can be used subcutenously or intravenou
if the subject carries out the treatment of bortezomib maintenence until 24 months after initiation of treatment
if the subject experiences progressive disease of multiple myeloma
or if the subject presents unacceptable adverse events.
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have diagnosed with multiple myeloma based on diagnostic criteria according to International myeloma working group (IMWG) and are able to judge participation voluntarily in clinical trial 2) Patients having grade 1 or lesser peripheral neuropathy 3) Patients who complete initial therapy for 6-12 months, that treatment have been maintained during the period including best response (best response is defined as sustained status of response for at least two cycles after reaching the minimal M peak level) 4) Patients who achieved major response including complete response, very good partial response and partial response after first induction chemotherapy 5) ECOG performance criteria: 0, 1, 2 6) Adequate hematologic function with absolute neutrophil count = 1,000/mm3, platelet count =75,000/mm3 7) Adequate hepatic function with serum aspartate aminotransferase, alanine aminotransferase < 3 times the upper limit of normal, serum total bilirubin < 2 times the upper limit of normal, 8) A negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause 9) Informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who presented relapse or refractory to induction treatment 2) Patients who plan to perform autologous stem cell transplantation 3) Patients who received an extensive radiation therapy within 4 weeks 4) Pregnant or lactating women 5) Seriously abnormal hepatic function with serum aspartate aminotransferase, alanine aminotransferase = 3 times the upper limit of normal; or serum total bilirubin = 2 times the upper limit of normal, 6) Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 7) Patients who received major surgery within 14 days 8) Multiple myeloma which involved central nervous system 9) Active uncontrolled infection or infection need to administrate intravenously antibiotics within 14 days 10) Patients who had diagnosed with Waldenstrom’s macroglobulinemia, POEMS syndrome, plasma cell leukemia, Al amyloidosis, myelodysplastic syndrome, or myeloproliferative neoplasm 11) Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy 12) Ongoing or active infection, known to be Human Immunodeficiency Virus (HIV) positive, clinically active hepatitis B or C 13) Have history of sensitive Bortezomib, Boron, mannitol 14) Acute respiratory distress syndrome or pericardial disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressino free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| In the absence of toxicity, Bortezomium is administered under 1.3 mg/m2/day or intravenously, and if toxic, it can be reduced according to toxicity. | — |
Countries
Korea, Republic of
Contacts
Public ContactYoorin Cho
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed