Multiple myeloma expressing CD20
Conditions
Interventions
Each patient receives a single 375 mg/m2 intravenous infusion of IDEC-C2B8 weekly for eight consecutive weeks. All patients are to be followed-up either until disease progression or at least for 8 mon
Sponsors
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be enrolled in this study: 1)patients with symptomatic multiple myeloma diagnosed by International Myeloma Working Group (IMWG) criteria (non-secretory myeloma to be excluded), having phenotype of CD38++ /CD20+ (25% and over) by CD38/CD20 two-color flow cytometry after CD45 (-) gating. 2)patients who failed to respond to the prior chemotherapy or who relapsed after achieving clinical response to the prior chemotherapy. 3) patients with prior chemotherapy regimens three or less -Massive dose therapy with steroid(s) to be counted one regimen. -Intensive chemotherapy with bone marrow transplantation to be counted one regimen (patients who received allogenic transplantation to be excluded in this protocol) 4)patients for their last chemotherapy have completed at least four weeks prior to the screening. In case, however, that autologous BM- or PBSC-transplantation has been performed, at least three months should be relapsed prior to the screening. 5)patients who are expected to be alive for at least six months. 6)patients between 20 and 75 years old and with an Eastern Cooperative Oncology Group performance status (ECOG - PS) of 2 or less (PS 3 by bone pain may be included). 7)sero-negaitive for hepatitis B virus surface antigen, hepatitis B virus core antibody, hepatitis C virus antibody or human immunodeficiency virus antibody. 8)patients who agreed contraception during study and 6 months after the last administration of IDEC-C2B8. 9)patients who signed an informed consent form by him/herself for participation in this study.
Exclusion criteria
Exclusion criteria: Patients who meet any one of the following criteria should be excluded from this study: 1)pregnant or lactating woman 2)patients with a history of receiving a murine, chimeric, humanized and/or human MoAb. 3) patients showing the following clinical laboratory values: peutrophil<1x109/L serum creatinine>Nu x2[Nu:institution normal upper value] ALT,AST,ALP>Nu x3 peripheral blood tumor cell>2x109/L 4) patients who is addicted to alcohol and/or drug, and/or patients with mental disease. 5)patients who have no other active malignancies, myelodysplastic syndrome, myelofibrosis, serious illness, complication or infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate (ORR) for all eligible and evaluable patients | — |
Countries
Japan
Outcome results
None listed