UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026936
Receipt No. R000030818
Scientific Title Feasibility and efficacy of extended VRd as induction for transplant-eligible NDDM
Date of disclosure of the study information 2017/04/15
Last modified on 2017/06/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Feasibility and efficacy of extended VRd as induction for transplant-eligible NDDM
Acronym MMM01 eVRd study
Scientific Title Feasibility and efficacy of extended VRd as induction for transplant-eligible NDDM
Scientific Title:Acronym MMM01 eVRd 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 extended VRd induction therapy in transplant-eligible newly diagnosed multiple myeloma patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate of autologous peripheral blood stem cell harvest
Key secondary outcomes 1) CR after autologous transplantation
2) Response rate after induction therapy
3) Flow MRD negative after autologous transplantation
4) Number of harvested stem cells
5) Flow MRD negative in the collected stem cells bags
6) Adverse events

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 -Induction with Bortezomib/Lenalidomide/Dexamethasone (VRd) for 6 courses.
(Bor 1.3 mg/m2 d1,8,15, Len 25 mg/body d1-21, Dex 20 mg/body d1,2,8,9,15,16,22,23) q28days
-Peripheral blood stem cell harvest with Cyclophosphamide and G-CSF.
-Autologous stem cell transplantation following high-dose Melphalan 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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Multiple myeloma patients diagnosed with IMWG criteria (2014).
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 10

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 Medicine 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 04 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 12 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 04 Month 11 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.