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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000531
Receipt No. R000000642
Scientific Title Phase II study of rituximab in refractory or relapsed patients with multiple myeloma expressing CD20
Date of disclosure of the study information 2006/11/28
Last modified on 2013/04/01

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Basic information
Public title Phase II study of rituximab in refractory or relapsed patients with multiple myeloma expressing CD20
Acronym Phase II Study of Rituximab in MM w/CD20+
Scientific Title Phase II study of rituximab in refractory or relapsed patients with multiple myeloma expressing CD20
Scientific Title:Acronym Phase II Study of Rituximab in MM w/CD20+
Region
Japan

Condition
Condition Multiple myeloma expressing CD20
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of IDEC-C2B8 mono-therapy at 375 mg/m2 x weekly eight infusions in relapsed or refractory MM w/ CD20+.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall response rate (ORR) for all eligible and evaluable patients
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key 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.
Key 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.
Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensi Suzuki, MD
Organization Japanese Red Cross Medical Center
Division name Department of Hematology
Zip code
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo 150-0012, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Zenyaku Kogyo Co., Ltd.
Division name Clinical Development Department
Zip code
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan
TEL 03-3986-1405
Homepage URL
Email

Sponsor
Institute Zenyaku Kogyo Co., Ltd.
Institute
Department

Funding Source
Organization Zenyaku Kogyo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-060246
Org. issuing International ID_1 JAPIC
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 11 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2006 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 04 Month 01 Day
Date trial data considered complete
2008 Year 04 Month 01 Day
Date analysis concluded
2008 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 11 Month 28 Day
Last modified on
2013 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000642

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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