UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024165 |
|---|---|
| Receipt number | R000027823 |
| 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 phase 2 study |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2026/07/29 10:26:52 |
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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 phase 2 study
Acronym
JSCT-MM16
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 phase 2 study
Scientific Title:Acronym
JSCT-MM16
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, lenalidomide, and dexamethasone (VRD).
Conditioning regimen in autologous stem cell transplantation: bortezomib and high-dose melphalan.
Consolidation therapy: carfilzomib, lenalidomide, and dexamethasone (KRD).
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 (CR) rates after consolidation therapy.
Key secondary outcomes
1. CR + stringent CR (sCR) rates after induction therapy.
2. CR + sCR rates after autologous stem cell transplantation.
3. sCR rates after consolidation therapy.
4. CR + sCR rates after maintenance therapy.
5. 3-years progression free survival (PFS)
6. 3-years overall survival (OS)
7. 3-years Time to Treatment Failure (TTF)
8. Incidence of adverse events.
9. Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation 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 (4 courses, every 3 weeks)
scBor 1.3mg/m2 day1,4,8,11 + Len 25mg/body day1-14 + Dex 40mg/body day1,4,8,11
PBSC harvest
scBor 1.3mg/m2 day1,4,8,11 + CY 1.5g/m2 day8,9 + G-CSF
High dose chemotherapy and PBSCT
scBor 1.3mg/m2 day-4,-1,3,6 + HD-Mel 100mg/m2 day-3,-2 PBSCT day0
Consolidation therapy (4 courses, every 4 weeks)
Cfz 20/27mg/m2 day1,2,8,9,15,16 + Len 25mg/body day1-21 + Dex 40mg/body day1,8,15
Maintenance therapy (every 4 weeks until PD)
Len 10mg/day day1-21 until-PD
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. Age from 20 to 65 years old.
2. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
3. Measureable M protein in serum or urine or abnormal serum kappa/lambda ratio by the serum free light chain measurement.
4. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.)
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 according to the proposal of RevMate. For male patients, to agree the appropriate method of contraception during the study according to the proposal of RevMate.
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 having been obtained.
Key exclusion criteria
1. Non-secretory MM, plasma cell leukemia, POEMS syndrome, and Waldenstrom Macroglobulinemia.
2. Patients with amyloidosis.
3. Patients who have been undergoing surgery or radiation treatment within 14 days before participating the study.
4. Patients who received prednisolone more than 30mg/day within 14 days before participation.
5. Involvement of central nervus system with myeloma cells
6. Patients HIV-positive, HBs antigen positive, and HCV antibody positive (except HCV-PCR negative).
7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
8. Patients with a history of active malignancy during the past 5 years.
9. Patients with psychiatric disorders such as schizophrenia etc.
10. Pregnant women, pre-menopausal women, and lactating women.
11. History of hypersensitivity to mannitol or boron.
12. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
13. Those who are considered as inappropriate to register by attending physicians.
Target sample size
133
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyushu University Graduate School of Medical Science
Division name
Department of Medicine and Biosystemic Science
Zip code
812-8582
Address
Fukuoka, Japan
TEL
092-
jsct-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Miyamoto |
Organization
JSCT
Division name
MM16 DC
Zip code
104-0031
Address
104-0031
TEL
03-6225-2025
Homepage URL
jsct-office@umin.ac.jp
Sponsor or person
Institute
JSCT
Institute
Department
Personal name
Funding Source
Organization
CELGENE K.K.
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
a
Address
a
Tel
a
a
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 | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://hp-jsct.jp/
Publication of results
Published
Result
URL related to results and publications
https://hp-jsct.jp/
Number of participants that the trial has enrolled
143
Results
The primary endpoint, the complete response (CR) rate after KRD, was 59% (90% CI, 52-66). This result met the prespecified threshold of 46%.
Results date posted
| 2026 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged 20-65 years with an ECOG performance status of 0-2.
Participant flow
Patients received four 3-week cycles of scVRD consisting of subcutaneous bortezomib 1.3 mg/m2 twice weekly for 2 weeks and lenalidomide 25 mg daily for 2 weeks. Peripheral blood stem cell harvest (PBSCH) was performed using cyclophosphamide 3 g/m2 plus bortezomib. Conditioning consisted of high-dose melphalan plus bortezomib (B-MEL). Four cycles of KRD were administered starting 90 +/- 30 days after ASCT, followed by maintenance lenalidomide 10 mg daily.
Adverse events
The major grade 3 or higher adverse events during scVRD were rash (16%), hematologic toxicity (14%), peripheral neuropathy (11%), infection (9%), and elevated liver enzymes (9%). During KRD, the major grade 3 or higher adverse events were hematologic toxicity (35%) and infection (5%).
Outcome measures
Primary endpoint:
Complete response (CR) rate after consolidation therapy.
Secondary endpoints:
Complete response (CR) and stringent complete response (sCR) rates after induction therapy.
Complete response (CR) and stringent complete response (sCR) rates at 90 days after autologous peripheral blood stem cell transplantation (ASCT).
Stringent complete response (sCR) rate after consolidation therapy.
Complete response (CR) and stringent complete response (sCR) rates at 3 years after initiation of protocol treatment.
3-year progression-free survival (3-year PFS).
3-year overall survival (3-year OS).
3-year time to treatment failure (3-year TTF).
Incidence of adverse events.
Molecular complete response (mCR) rates after induction therapy, after ASCT, after consolidation therapy, and 1 year after initiation of maintenance therapy.
Molecular minimal residual disease (MRD) in harvested stem cell products.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027823
