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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032659
Receipt No. 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 2019/05/22

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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 CR rate after KRd therapy
Key secondary outcomes 1)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
65 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. PR and VGPR after autologous stem cell transplantation.
6. ECOG-Performance Status (PS) is 0-2.
7. 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%
8. Patient who has Grade <= 2 peripheral neuropathy without pain (NCI CTCAE ver.4).
9. Patient who can agree the registration for RevMate and keep its administrative procedure.
10. Patient who provided written consents for this study.
Key exclusion criteria 1. CR after autologous stem cell transplantation.
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 22

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
Email 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
Email daisukekud@jadecom.jp

Sponsor
Institute Ochanomizu Hematology Study Group
Institute
Department

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
Email t-tanaka@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 Open public 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
2022 Year 05 Month 21 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
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036700

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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