UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028421 |
|---|---|
| Receipt number | 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 | 2023/08/14 17:26:38 |
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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 | Kazuki |
| Middle name | |
| Last name | Tanimoto |
Organization
Fukuoka Red Cross Hospital
Division name
Department of Hematologyand Oncology
Zip code
815-8555
Address
3-1-1 okusu minami-ku, Fukuoka
TEL
092-521-1211
fbmtg-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Study Office |
| Middle name | |
| Last name | FBMTG |
Organization
FBMTG
Division name
FBMTG Study Office
Zip code
815-8555
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5315
Homepage URL
fbmtg-office@umin.ac.jp
Sponsor or person
Institute
FBMTG
Institute
Department
Personal name
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
fukuoka
Address
fukuoka
Tel
tel
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
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032527
