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


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 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


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

Value
https://center6.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