None listed
Conditions
Interventions
Drug : * CVD arm
Bortezomib 1.3mg/m2 SC , D1, D8, D15, D22
Cyclophosphamide 300 mg/m2, PO, D1, D8, D15
Dexamethasone 20mg/day, PO or IV push, D1-2, D8-9, D15-16, D22-23
(repeated every 4 weeks, total
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with multiple myeloma treated with one or more induction regimens and autologous stem cell transplantation 2) age 20 ~ 64 3) patients who were treated with thalidomide-based regimen or VAD-like induction regimens 4) patients who acheived very good partial response (VGPR) or near complete response (nCR) whitn 12 weeks after autologous stem cell transplantation 5) Treated with 140 ~ 200 mg/m2 of melphalan as a conditioning 6) adequate bone marrow function; ANC > 1,000/uL Hemoglobin > 9.0 g/dL Platelets > 70 x 103/uL 7) adequate hepatic function; Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 50% (measured by echocardiography or MUGA scan) 9) adequate performance status; ECOG performance scale 0-2 10) negative pregnancy test (serum or urine) before study initiation or persistent amenorrhea for more than 1 years, for women in the reproductive age 11) patients who agree with keep adequate contraception 12) patients who are expected to survive for more than 6 months 13) patients who voluntarily agreed and signed the informed consent
Exclusion criteria
Exclusion criteria: 1) primary amyloidosis, smoldering myeloma, MGUS 2) plasmacytic leukemia 3) peripheral neuropathy > grade 2 at the enrollment 4) Ongoing toxicity due to previous treatment > grade 2 5) Progressive disease after ASCT 6) additional chemotherapy or radiation after ASCT 7) Serious medicall illness or psychologic problems 8) HIV positivity 9) Active HBV or HCV infection 10) Hypersensitivity to bortezomib, boron, or mannitol 11) active, severe infection that required immediate treatment 12) pregnant or lactating women 13) Serious cardiovascular diseases 14) Previous history of malignancy within 5 years except non-basal cell skin cancer and in situ carcinoma of cervix uteri 15) patients who are administered study drugs as a part of other clinical trials , any chemotherapeutic agents, or immunotherapy 16) patients who are in any medical condition not adequate to enroll this clinical trial determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate after CVD consolidation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;overall survival, OS;safety profiles | — |
Countries
Korea, Republic of
Contacts
Public ContactHEE JUNG YOO
National Cancer Center
Outcome results
None listed