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 |
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Health condition(s) or Problem(s) studied | Multiple myeloma expressing CD20 |
Date of first enrollment | 2006/07/01 |
Target sample size | 39 |
Countries of recruitment | Japan |
Study type | Interventional |
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. |
Outcome(s)
Primary Outcome | overall response rate (ORR) for all eligible and evaluable patients |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude 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. |
Related Information
Primary Sponsor | Zenyaku Kogyo Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Zenyaku Kogyo Co., Ltd. |
Secondary ID(s) | JapicCTI-060246 |
Contact
public contact | |
Name | |
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 |
Telephone | |
Affiliation | Japanese Red Cross Medical Center Department of Hematology |