UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007945
Receipt number R000009358
Scientific Title Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study
Date of disclosure of the study information 2012/05/20
Last modified on 2012/05/14 14:26:01

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Basic information

Public title

Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study

Acronym

Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study

Scientific Title

Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study

Scientific Title:Acronym

Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study

Region

Japan


Condition

Condition

Multiple Myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy and safety of lenalidomide and prednisone therapy in Japanese multiple myeloma patients who are over 70 years old.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Best response rate

Key secondary outcomes

Rate of adverse events
Duration of response
Progression-free survival
Overall survival


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

Lenalidomide 15mg/day days1-21, prednisone 15mg/day three times a week, in a 28-day cycle

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

.Multiple myeloma patient who is over 70 years old
.Agree to register and follow RevMate
.In the patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained

Key exclusion criteria

.Cardiac infarction within 6 months
.Deep vein thrombosis or pulmonary embolism within 3 years
.Tuberculosis, herpes simplex keratitis, mycosis, or other active infections at baseline
.Uncontrollable diabetes mellitus, hypertension, peptic ulcer, or glaucoma
.Posterior capsule opacification
.Patients with mental illness
.Those who are considered as inappropriate to register by attending physicians
.Pregnant or breast feeding females
.Known hypersensitivity to prednisone

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name kazuo tsubaki

Organization

Nara Hospital Kinki University School Of Medicine

Division name

Department of Hematology

Zip code


Address

1248-1 Otsuda, Nara, 630-0293 JAPAN

TEL

0743-77-0880

Email



Public contact

Name of contact person

1st name
Middle name
Last name hitoshi hanamoto

Organization

Nara Hospital Kinki University School Of Medicine

Division name

Department of Hematology

Zip code


Address

1248-1 Otsuda, Nara, 630-0293 JAPAN

TEL

0743-77-0880

Homepage URL


Email

hanamoto@nara.med.kindai.ac.jp


Sponsor or person

Institute

Nara Hospital Kinki University School Of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

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

2012 Year 05 Month 20 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

Open public recruiting

Date of protocol fixation

2011 Year 04 Month 19 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 05 Month 14 Day

Last modified on

2012 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009358


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name