UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000531 |
|---|---|
| Receipt number | 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 10:43:59 |
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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
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
Sponsor or person
Institute
Zenyaku Kogyo Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000642
