UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility and efficacy of triplet regimen in transplant-ineligible NDMM patients
Title of the study (Brief title)	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	Satoshi Yoshihara
Organization	Hyogo College of Medicine
Division name	Department of Transfusion and Cellular Therapy
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6348
Email	yoshihar@hyo-med.ac.jp

Public contact
Name of contact person	Satoshi Yoshihara
Organization	Hyogo College of Medicine
Division name	Department of Transfusion Medicine and Cellular Therapy
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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