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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027978
Receipt No. R000031916
Scientific Title Feasibility and efficacy of triplet regimen in transplant-ineligible NDMM patients
Date of disclosure of the study information 2017/07/15
Last modified on 2017/06/28

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Basic information
Public title Feasibility and efficacy of triplet regimen
in transplant-ineligible NDMM patients
Acronym MMM02 "Triplet for elderly MM" study
Scientific Title Feasibility and efficacy of triplet regimen
in transplant-ineligible NDMM patients
Scientific Title:Acronym MMM02 "Triplet for elderly MM" 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 examine the safety and efficacy of triplet induction therapy using dose-adjusted
VRd or IRd in transplant-ineligible newly diagnosed multiple myeloma patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CR rate after the completion of the induction therapy
Key secondary outcomes 1) Response rate (VGPR, MRD negative) after the completion of the induction therapy
2) Adverse events
3) Quality of life at the time of the enrollment, after 6 courses of the induction therapy, and after the completion of the induction therapy

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 0. Determination of the Frailty score and
the drug dose.
0-1. Frailty score
Determine the frailty score based on age, Charlson index, ADL score, and IADL score.
0-2. Determine the drug dosages based on the frailty score.
0-3. Assess the baseline QOL.

1. Start of the treatment

2. Induction therapy
2-1. DA-VRd (q28 days)
-Lenalidomide X mg/body days 1-21
-Bortezomib X mg/m2 sc days 1, 8, 15 (days 1, 15 for frail patients)
-Dex X mg/body po on days 1, 2, 8, 9, 15, 16, 22, 23
2-2. Switch to IRd if patients are intolerant to VRd.
-Lenalidomide X mg/body days 1-21
-Ixazomib X mg/m2 sc days 1, 8, 15
-Dex X mg/body po on days 1, 2, 8, 9, 15, 16, 22, 23
2-3. Assess the response and QOL after 6 courses.
2-4. Continue DA-VRd or IRd for 6 more courses.
2-5. Assess the response and QOL after 12 courses.

3. Maintenance therapy
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 patients diagnosed with IMWG criteria (2014), who are 65 or older, or autologous transplant-ineligible due to comorbidities.
2) Patients with measurable disease.
3) Laboratory data.
Neutrophil > 1000/mm3
Hb > 8.0g/dL
Platelet > 75000/mm3
T-Bil < 1.5x UNL
AST, ALT < 3x UNL
Ccr > 30mL/min
4) Performance Status: 0-2
Key exclusion criteria 1) Smoldering or IgM myeloma, solitary plasmacytoma, plasma cell leukemia, POEMS syndrome, WM
2) CNS involvement
3) HIV+, HBs Ag+, or HCV Ab+
4) Severe abnormality in the liver, kidney, cardiac, or pulmonary functions. Severe diabetes, hypertension, or infection.
5) Severe psychotic disorders.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Yoshihara
Organization Hyogo College of Medicine
Division name Department of Transfusion and Cellular Therapy
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6348
Email yoshihar@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Yoshihara
Organization Hyogo College of Medicine
Division name Department of Transfusion Medicine and Cellular Therapy
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6348
Homepage URL
Email yoshihar@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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
2017 Year 07 Month 15 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 15 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
2017 Year 06 Month 28 Day
Last modified on
2017 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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