UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039016
Receipt number R000044367
Scientific Title IRD (ixazomib, lenalidomide, and dexamethasone) consolidation therapy after autologous peripheral hematopoietic stem cell transplantation for elderly multiple myeloma patients.
Date of disclosure of the study information 2019/12/28
Last modified on 2023/10/04 15:08:59

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Basic information

Public title

IRD (ixazomib, lenalidomide, and dexamethasone) consolidation therapy after autologous peripheral hematopoietic stem cell transplantation for elderly multiple myeloma patients.

Acronym

IRD consolidation after ASCT

Scientific Title

IRD (ixazomib, lenalidomide, and dexamethasone) consolidation therapy after autologous peripheral hematopoietic stem cell transplantation for elderly multiple myeloma patients.

Scientific Title:Acronym

IRD consolidation after ASCT

Region

Japan


Condition

Condition

multiple myaloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety of IRD consolidation therapy after ASCT for MM

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Completion rate of 4 cycles of IRD consolidation 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

4 cycles of IRD consolidation therapy will be administered.
ixazomib 3mg at day 1,8, 15 on a 28-day cycle basis.
lenalidomide 15mg at day 1-21 on a 28-day cycle basis.
dexamathasone 20mg day 1, 8, 15, 22 on a 28 day cycle basis.

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

18 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Participants must sign the most current institutional review board (IRB)-approved informed consent form(ICF).
2) Multiple myeloma patients who received ASCT in 3 months and achieved partial response or better.
3) Age 65 - 74 years or <65 years who are not deemed appropriate for KRD consolidation therapy.
4) ECOG performance status 0-1.
5) Neutrophil >1000 and platelet >75000.
6) Serum GOT or GPT < 3.0 X upper limit of normal (ULN), and Serum total bilirubin < 1.5 ULN
7) Serum creatinine clearance > 30 ml/min.

Key exclusion criteria

1) Peripheral neuropathy grade > 2
2) Uncontrolled diabetes.
3) Uncontrolled hypertension, arrhythmia, or heart failure.
4) Uncontrolled infectious diseases.
5) Uncontrolled psychiatric disorders.
6) Pregnant or lactating patients.
7) Allergic to ixazomib or lenalidomide.
8) Inability to comply with RevMmate.
9) Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

Target sample size

28


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Tanimura

Organization

Tokyo-Kita Medical Center

Division name

Department of Hematology

Zip code

115-0053

Address

4-17-56 Akabanedai, Kita-ku, Tokyo

TEL

03-5963-3311

Email

akiratan@jadecom.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Tanimura

Organization

Tokyo-kita Medical Center

Division name

Department of Hematology

Zip code

115-0053

Address

4-17-56 Akabanedai, Kita-ku, Tokyo

TEL

03-5963-3311

Homepage URL


Email

akiratan@jadecom.jp


Sponsor or person

Institute

Tokyo-Kita Medical Center

Institute

Department

Personal name



Funding Source

Organization

not applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo-Kita Medical Center

Address

4-17-56 Akabanedai, Kita-ku, Tokyo

Tel

03-5963-3311

Email

tk-umin@tokyokita-jadecom.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

2019 Year 12 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

Enrolling by invitation

Date of protocol fixation

2019 Year 12 Month 10 Day

Date of IRB

2019 Year 12 Month 26 Day

Anticipated trial start date

2020 Year 01 Month 06 Day

Last follow-up date

2024 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

2019 Year 12 Month 27 Day

Last modified on

2023 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name