UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter clinical trials to determine the efficacy and safety of consolidation and maintenance therapy with ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma.
Acronym	prospective trial of ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma
Scientific Title	Multicenter clinical trials to determine the efficacy and safety of consolidation and maintenance therapy with ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma.
Scientific Title:Acronym	prospective trial of ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma
Region	Japan

Condition
Condition	refractory multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of consolidation and maintenance therapy with IRd therapy in patients with transplant-ineligible multiple myeloma.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The rate of stringent CR achievemnt during the IRd therapy.
Key secondary outcomes	1 Time to sCR achievement period 2 MRD negativity achievement rate 3 ORR 4 Safety 5 PFS 6 OS 7 pharmacokinetics of lenalidomide, ixazomib

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	The patients are treated with ixazomib (Day1, 8, 15) and lenalidomide (Day1-21) and dexamethasone (Day1, 8, 15, 22) therapy every 28 day cycle for 1 year
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 MM patients with PR, VGPR, CR 2 transplant-ineligible MM patients without the improvement of response depth during the most recent 6 cycles of Ld therapy. 3 with consent 4 measureble M-protein 5 PS 0-2 6 contraceptive
Key exclusion criteria	1 relapsed myeloma 2 previous treatment history of ixazomib 3 not tolerable to lenalidomide, bortezomib, dexamethasone 4 with Grade 2 or higher peripheral neuropathy 5 pregnancy 6 Abnormality of blood test 7 CNS involvement 8 Plasma cell leukemia 9 with severe infection 10 with intestinal pneumoniae 11 with double and more cancer 12 without consent of blood transfusion 13 and other
Target sample size	41

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahiro Kobayashi
Organization	Akita University Graduate School of Medicine
Division name	Department of Hematology, Nephrology, Rheumatology,
Zip code
Address	1-1-1 Hondo, Akita City, Akita, Japan
TEL	018846116
Email	takahiro@med.akita-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takahiro Kobayashi
Organization	Akita University Graduate School of Medicine
Division name	Department of Hematology, Nephrology, Rheumatology,
Zip code
Address	1-1-1 Hondo, Akita City, Akita, Japan
TEL	018846116
Homepage URL
Email	takahiro@med.akita-u.ac.jp

Sponsor
Institute	Akita University hosipital
Institute
Department

Funding Source
Organization	none
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	2018 Year 06 Month 01 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	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 14 Day
Date of IRB	2018 Year 03 Month 14 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2027 Year 01 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	2018 Year 05 Month 22 Day
Last modified on	2022 Year 05 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037258