UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008918
Receipt number R000010460
Scientific Title Low dose of lenalidomide and dexamethasone therapy for eldery multiple myeloma
Date of disclosure of the study information 2012/09/14
Last modified on 2012/09/14 14:32:48

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Basic information

Public title

Low dose of lenalidomide and dexamethasone therapy for eldery multiple myeloma

Acronym

Mini-Rd for eldery multiple myeloma

Scientific Title

Low dose of lenalidomide and dexamethasone therapy for eldery multiple myeloma

Scientific Title:Acronym

Mini-Rd for eldery multiple myeloma

Region

Japan


Condition

Condition

Refractory or relapsed symptomatic multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy of low dose of lenalidomide and dexamethasone therapy for elderly refractory multiple myeloma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Partial remission rate within a year after the therapy

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients were administrated with lenalidomide of 5 mg per day for 21 days and dexamethasone of 8 mg per day weekly for a cycle of 28 days. Numbers of cycle are not determined.

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

*Refractory or relapsed symptomatic multiple myeloma
*patient must be 70 or more than 70 years old at registration, or patients age of lower than 70 are also included if they are considered to be intolerable for ordinary treatment of lenalidomide because of the comorbidities such as previously infectious disease.
*Patient must be informed consent with their signature.

Key exclusion criteria

*Patients who have allergy for the drugs used in this study
*Patients who have active infectious disease
*Patients who are decided as inappropriate by corresponding doctor.

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sachiko Kimura

Organization

Nishiwaki municipal hospital

Division name

Internal medicine

Zip code


Address

652-1, shimotoda, nishiwaki , Hyogo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Chiho Kinugasa

Organization

Nishiwaki municipal hospital

Division name

management division

Zip code


Address


TEL


Homepage URL


Email

kminagaw@med.kobe-u.ac.jp


Sponsor or person

Institute

Nishiwaki municipal hospital

Institute

Department

Personal name



Funding Source

Organization

N.A.

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 09 Month 14 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

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 07 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 09 Month 14 Day

Last modified on

2012 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010460


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name