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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028421
Receipt No. R000032527
Scientific Title Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed elderly symptomatic multiple myeloma: phase 2 study FBMTG EMM17
Date of disclosure of the study information 2017/10/01
Last modified on 2017/10/01

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Basic information
Public title Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed elderly symptomatic multiple myeloma: phase 2 study
FBMTG EMM17
Acronym FBMTG EMM17
Scientific Title Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed elderly symptomatic multiple myeloma: phase 2 study
FBMTG EMM17
Scientific Title:Acronym FBMTG EMM17
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to investigate efficacy and safety of new drugs in each phase of treatment in patients with newly diagnosed elderly symptomatic multiple myeloma.
Induction therapy: bortezomib, lenalidomide, and dexamethasone (VRD). Conditioning regimen in autologous stem cell transplantation: bortezomib and high-dose melphalan. Consolidation therapy: ixazomib, lenalidomide, and dexamethasone (IRD).
Maintenance therapy: lenalidomide (until-PD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete response rate after consolidation
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 scVRD induction : Four 3-week cycles of scVRD. Cycle 1, subcutaneous bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11, oral Lenalidomide 25 mg on days 1 to 14, and dexamethasone 40 mg/day on days 1, 4, 8, 11. Cycle2-4, subcutaneous bortezomib 1.3 mg/m2 on days 1, 8 and 15, Lenalidomide 25 mg on days 1 to 14, and dexamethasone 40 mg/day on days 1, 8 and 15.

scBor-plerixafor-G-CSF PBSC mobilization : subcutaneous bortezomib 1.3 mg/m2 on days 1 and 4, and subcutaneous plerixafor 0.24 mg/ kg on day 4 and G-CSF 10ug/kg on day1-5 and PBSCH after day 5. The collection goal is 2.0x10^6 CD34+ cells/kg.

High dose chemotherapy and PBSCT : subcutaneous bortezomib 1.3mg/m2 on days -4,-1, 3 and 6, L-PAM 70mg/m2 on days -3, and -2, and PBSCT at day 0.

IRD consolidation : Four 4-week cycles of oral ixazomib 4mg on days 1, 8 and 15, oral lenalidomide 15 mg on days 1 through 21 of each 28-days cycle, and dexamethasone 40 mg/day on days 1, 8 and 15.

Lenalidomide maintenance : 4-week cycles of oral lenalidomide 10 mg on days 1 through 21 of each 28-days cycle until disease progression or intolerable adverse event.
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
66 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria All the following criteria MUST be met:
1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
2) Measureable M protein in serum or urine.
3) Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.)
4) Age: 66-75 years old
5) Main Organ function is maintained
6) Those who are evaluated to be able to survive more than 3 months.
7) For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study.
8) In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.
Key exclusion criteria 1) Non-secretory MM and plasma cell leukemia.
2) Patients HIV-positive
3) Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
4) Patients with a history of active malignancy during the past 5 years.
5) Patients with psychiatric disorders such as schizophrenia etc.
6) Pregnant women, pre-menopausal women, and lactating women.
7) History of hypersensitivity to mannitol or boron.
8) Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary
9) Those who are considered as inappropriate to register by attending physicians.
Target sample size 49

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Tanimoto
Organization Fukuoka Red Cross Hospital
Division name Department of Hematologyand Oncology
Zip code
Address 3-1-1 okusu minami-ku, Fukuoka
TEL 092-521-1211
Email fbmtg@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name FBMTG Study Office
Organization FBMTG
Division name FBMTG Study Office
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5315
Homepage URL
Email fbmtg@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute FBMTG
Institute
Department

Funding Source
Organization Celgene
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
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 10 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 10 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 07 Month 28 Day
Last modified on
2017 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032527

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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