NIPH Clinical Trials Search

UMIN ID: UMIN000000531

Registered date:28/11/2006

Phase II study of rituximab in refractory or relapsed patients with multiple myeloma expressing CD20

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMultiple myeloma expressing CD20
Date of first enrollment2006/07/01
Target sample size39
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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 months counting from the initial treatment of IDEC-C2B8.


Primary Outcomeoverall response rate (ORR) for all eligible and evaluable patients
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriaPatients 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.

Related Information


public contact
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan Japan
Telephone 03-3986-1405
Affiliation Zenyaku Kogyo Co., Ltd. Clinical Development Department
scientific contact
Name Kensi Suzuki, MD
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo 150-0012, Japan Japan
Affiliation Japanese Red Cross Medical Center Department of Hematology