UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007216 |
|---|---|
| Receipt number | R000008493 |
| Scientific Title | Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase2 study |
| Date of disclosure of the study information | 2012/02/02 |
| Last modified on | 2018/08/17 16:31:26 |
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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 symptomatic multiple myeloma: a phase2 study
Acronym
JSCT-MM12
Scientific Title
Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase2 study
Scientific Title:Acronym
JSCT-MM12
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 symptomatic multiple myeloma, and to investigate efficacy of detection of minimal residual disease (MRD).
Induction therapy: bortezomib, cyclophosphamide, and dexamethasone (VCD).
Conditioning regimen in autologous stem cell transplantation: bortezomib and high-dose melphalan.
Consolidation therapy: bortezomib, thalidomide, and dexamethasone (VTD).
Maintenance therapy: lenalidomide (one year).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Probability of CR after consolidation therapy.
Key secondary outcomes
1. Probability of CR + sCR after induction therapy.
2. Probability of CR + sCR after autologous stem cell transplantation.
3. Probability of sCR after consolidation therapy.
4. Probability of CR + sCR after maintenance therapy.
5. 2-years progression free survival (PFS)
6. 2-years overall survival (OS)
7. Time to progression (TTP)
8. Incidence of adverse events.
9. Probability of molecular remission (mCR) after autologous stem cell transplantation, consolidation therapy, and maintenance therapy.
10. Detection of minimal residual disease (MRD) in autologous grafts.
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 therapy
1st course: Bortezomib 1.3mg/m2 iv (day1,4,8,11), cyclophosphamide 500mg/m2 iv (day1, 8), dexamethasone 40mg/body po (day 1,4,8, 11)
2nd and 3rd courses: Bortezomib 1.3mg/m2 iv (day1,8,15,22), cyclophosphamide 300mg/m2 iv (day1,8,15,22), dexamethasone 40mg/body po (day1,8,15,22).
PBSC harvest: Cyclophosphamide 1.5g/m2 div (day 1 , 2)
High dose chemotherapy and PBSCT: Bortezomib 1.3mg/m2 iv (day-4,-1). L-PAM 100mg/m2 div (day -3,-2). PBSCT (day 0)
Consolidation therapy (2 courses): Bortezomib 1.3mg/m2 iv (day1,8,15,22), thalidomide 100mg/body p.o. (day1-35), and dexamethasone 40mg/boby (day1,8, 15, 22).
Maintenance therapy (one year): Lenalidomide 10mg/body p.o. (day 1 to 21)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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 from 20 to 65 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 plasmacell 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
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Sunami |
Organization
National Hospital Organization Okayama Medical Center
Division name
Division of Hematology
Zip code
Address
Okayama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
JSCT
Division name
MM12 datacenter
Zip code
Address
TEL
Homepage URL
jsct-office@umin.ac.jp
Sponsor or person
Institute
Japan Study Group for Cell Therapy and Transplantation
Institute
Department
Personal name
Funding Source
Organization
Resarch Foundation for Community Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
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
| 2012 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | 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
| 2012 | Year | 02 | Month | 02 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008493
