UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032659 |
|---|---|
| Receipt number | R000036700 |
| Scientific Title | A phase 2 study of KRd(carfilzomib, lenalidomide, dexamethasone) consolidation for newly diagnosed multiple myeloma |
| Date of disclosure of the study information | 2018/05/22 |
| Last modified on | 2022/01/27 11:30:13 |
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Basic information
Public title
A phase 2 study of KRd(carfilzomib, lenalidomide, dexamethasone) consolidation for newly diagnosed multiple myeloma
Acronym
OCHA-KRd
Scientific Title
A phase 2 study of KRd(carfilzomib, lenalidomide, dexamethasone) consolidation for newly diagnosed multiple myeloma
Scientific Title:Acronym
OCHA-KRd
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of KRd(carfilzomib, lenalidomide, and dexamethasone) as consolidation therapy after first autologous stem cell transplantation for patients with newly diagnosed multiple myeloma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRD negative rate after KRd therapy
Key secondary outcomes
1)iCR,sCR,CR,VGPR and PR after KRd therapy 2 cycles and 4 cycles
2)Progression free survival(PFS) after induction therapy
3)Overall survival(OS) after induction therapy
4)Incidence of adverse events
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
Consoilidation therapy
KRd 4 cycles, every 4 weeks
carfilzomib 20mg/m2 only first cycle day1,2
carfilzomib 27mg/m2 day1,2,8,9,15,16 after first cycle day 8
lenalidomide 15mg/body day1-21
dexamethasone 40mg/dody day 1,8,15,22
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
| 66 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Days 90 to 180 after autologous stem cell transplantation for patients with newly diagnosed multiple myeloma.
2. If patients received lenalidomide at induction therapy, they need to be tolerable more than lenalidomide 10 mg/day.
3. Age from 20 to 65 at autologous stem cell transplantation
4. No previous consolidation and maintenance therapy.
5. At least PR after autologous stem cell transplantation.
6. MRD in the BM is present(>=10*-4) after ASCT.
7. ECOG-Performance Status (PS) is 0-2.
8. Patent who meets the following criteria;
a) Renal function:Ccr >= 30ml/min (Cockroft-Gault).
b) Bone marrow function: ANC >= 1000/uL, Platelet >= 75,000/uL, Hb >= 8.0g/dl
c) Liver function: AST,ALT <= 2.5*ULN, T-Bil <= 1.5*ULN
d) Heart function: EF >= 50%
e) Pulmonary function: SpO2 >= 93%
9. Patient who has Grade <= 2 peripheral neuropathy without pain (NCI CTCAE ver.4).
10. Patient who can agree the registration for RevMate and keep its administrative procedure.
11. Patient who provided written consents for this study.
Key exclusion criteria
1. MRD in the BM is absent(<10*-4) after ASCT.
2. Patient who has hypersensitivity to the study drugs.
3. Uncontrolled or severe cardiovascular disease, including New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or cardiac amyloidosis.
4. Uncontrolled hypertention.
5. Uncontrolled active infection.
6. Past history of pulmonary embolism, myocardial infarction and cerebral infarction.
7. Past history of deep vein thrombosis, administration of anticoagulants and/or antiplatelet drugs within 3 years
8. HBs antigen positive and/or HCV positive.
9. Administration of HBV reatctivation.
10. Active advanced-stage cancer.
11. Female patient who is pregnant and/or breastfeeding.
12. Active gastrointestinal bleeding.
13. Past history of renal transplantation.
14. Uncontrolled diabetes mellitus.
15. Serious psychiatric illness
16. Patient who is judged to be medically unfit by his/her physician.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
daisukekud@jadecom.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
Homepage URL
daisukekud@jadecom.jp
Sponsor or person
Institute
Ochanomizu Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tokyo-kita Medical Center
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
Tel
03-5963-3311
tk-umin@tokyokita-jadecom.jp
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
東京北医療センター（東京都）、茨城県立中央病院（茨城県）、水戸医療センター（茨城県）、がん･感染症センター都立駒込病院（東京都）、東京医科歯科大学附属病院（東京都）、埼玉医科大学附属病院（埼玉県）、日立製作所日立総合病院（茨城県）、武蔵野赤十字病院（東京都）、横須賀共済病院（神奈川県） 、横浜市立みなと赤十字病院（神奈川県）、青梅市立総合病院（東京都）、花と森の東京病院（東京都）、埼玉医科大学国際医療センター（埼玉県）、都立墨東病院（東京都）、永寿総合病院（東京都）、聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 22 | 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 | 05 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 17 | 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 | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036700
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