UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022213
Receipt number R000025587
Scientific Title The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Date of disclosure of the study information 2016/05/11
Last modified on 2019/05/13 12:26:28

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Basic information

Public title

The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone

Acronym

Cytokine /chemokine profiles in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone

Scientific Title

The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone

Scientific Title:Acronym

Cytokine /chemokine profiles in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone

Region

Japan


Condition

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The serum cytokine level,chemokine level and the counts of peripheral lymphocytes.

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

Patients will receive Lenalidomide(25mg on days 1-21) and dexamethazone(40mg on days1,8,15,22 in patinets aged between 20 to 74 and 20mg on days 1,8,15,22 in patinets aged 75 years or more) on 28-day cycle. The dose of lenalidomide is adjusted based on the guideline.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Multiple myeloma diagnosed aged 20 years or more
2.Relapsed or refractory multiple myeloma without lenalidemide and medical history over the past 1 or 2 regimen
3.ECOG of Performance Status between 0 and 2
4.M protein in serum or urine is assessable.
5.Preserved function of major organs
6.Predicting survival time is more than 3 months.
7.Menopausal female or male and female who are enable to prevent conception by the adequate methods, including the surgical conception.
8.Informed consent in writing

Key exclusion criteria

1.Previous treatment with lenalidomide
2.Hypersensitivity to lenalidomide and/or dexamethasone
3.non-secretory myeloma, solitary plasmacytoma, plasma cell leukemia, of POEMS syndrome
4.Positivity of HBs antigen or, HCV or HIV antibody
5.Uncontrollable liver dysfunction, renal dysfunction, cardiac dysfunction, respiratory dysfunction, diabetes mellitus, hypertension and infection
6.Double cancer requiring treatments 7.Psychoneurotic disorder, depression state or history 8.Patients with pregnancy, patients who may be pregnant, or patients during lactation
9.Pulomonary fibrosis, interstitial pneumonitis or interstitial shadow on chest CT, even if no symptom 10.Ineligible patient by physicians decision

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takaaki
Middle name
Last name Ono

Organization

Hamamatsu University School of Medicine

Division name

Department of Internal Medicine III (Division of hematology)

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

TEL

+81-53-435-2267

Email

takaono@hama-med.ac.jp


Public contact

Name of contact person

1st name Yasuyuki
Middle name
Last name Nagata

Organization

Hamamatsu University School of Medicine

Division name

Department of Internal Medicine III (Division of hematology)

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

TEL

+81-53-435-2267

Homepage URL


Email

yasu@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Celgene

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

Division of Center for Clinical research, Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

Tel

+81-53-435-2676

Email

yamoto@hama-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 11 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

No longer recruiting

Date of protocol fixation

2015 Year 06 Month 09 Day

Date of IRB

2015 Year 09 Month 01 Day

Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 05 Day

Last modified on

2019 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025587


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name