UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022008
Receipt No. R000025358
Scientific Title (C-SHOT1601)Phase II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly BLd) for elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Date of disclosure of the study information 2016/04/20
Last modified on 2020/04/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title (C-SHOT1601)Phase II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly BLd) for elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Acronym (C-SHOT1601)Phase II study of Once weekly BLd therapy for elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Scientific Title (C-SHOT1601)Phase II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly BLd) for elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Scientific Title:Acronym (C-SHOT1601)Phase II study of Once weekly BLd therapy for elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Region
Japan

Condition
Condition Elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this trial is to evaluate the efficacy and safety of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed or refractory multiple myeloma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes objective response rate, very good PR (VGPR) above
Key secondary outcomes CR rate
overall response (PR above)
overall survival
progression-free survival
adverse event
treatment efficacy according to the translocation of chromosome myeloma related

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 bortezomib (subcutaneous injection, days 1,8) plus lenalidomode (days 1-14) dexamethasone (20mg/day, days
1,2,8,9) were administered for eight 21-cycles.

bortzomib 1.3 mg/m2, lenalidomide 25mg/body, dexamethasone 20 mg/body

Dose of lenalidomide is adjused accroding to the degree of renal failure.

Twenty cycle of Ld thrapy is conducted following to the 8 cycle of BLd therapy.

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) diagnosed as having symptomatic multiple myeloma
2) 65 years of age or more, under 80
3) transplant in-eligble patients with 20 years or more and under 64 years.
4) either menopausal women aged at 50 or older, women after hysterectomy, or women after bilateral ovariectomy. Females of childbearing potential must adhere to the guideline of the Revmate program.
5) men who agreed to use contraception according to the guideline of the Revmate program.
6) performance status 0-2,or 3 due to osteolytic lesions alone
7) having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0gdL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA IgD, or urinary excretion of at least 0.2g of paraprotein per 24 hours in spite of the type of myeloma
8) No history of myeloma treatment.Transient administration of steroid is permitted
9) absolute neutrophil count no less than 1000/mm3, platelet count no less than 75,000/mm3,
, AST/ALT no more than 100IU/L, total bilirubin 1.8 mg/dL or below, creatinine clearrance 30 mL/min or above
SpO2 (room air) at least 94%, ECG neither ischemic change nor arrhythmia reqiuring medical intervention, cardiac ejection fraction at least 50%
10) peripheral neuropathy(PN) within grade 2 without pain. Management of PN is permitted.
11) written informed consent by the patient
Key exclusion criteria 1) synchronous or metachronous malignancy
2) active infection
3) severe constipation or illeus
4) interstitial pneoumonia, pulmonary fibrosis
5) uncontrolled diabetes
6) inability to intake antithrombotic medication
7) pregnant or nursing women mellitus
8) uncontrollable hypertension
9) psychological disturbance
10) active double cancer
11) HBs-Ag positive or HCV-Ab positive or HIV-Ab positive
12) grade 3 or higher peripheral neuropathy, or grade 1 or higher neuralgia
13) glaucoma
14) primary plasma cell leukemia
15) no adminstration of blood transfusion or G-CSF within 7days befor the treatment
16) no evidence of cardiac or intestinal amyloidosis
17) allergic history to borate or mannitol
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ri
Middle name
Last name Masaki
Organization Nagoya City University Hospital
Division name Division of Hematology & Oncology
Zip code 4670801
Address 1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL 052-853-8738
Email rrmasaki@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name RI
Organization Nagoya City University Hospital
Division name Division of Hematology & Oncology
Zip code 4670801
Address 1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
TEL 052-853-8738
Homepage URL
Email rrmasaki@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Hospital

Division of Hematology & Oncology
Institute
Department

Funding Source
Organization Celgene JAPAN
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 Nagoya City University Hospital IRB
Address 1, Aza-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601, Japan
Tel 052-858-7215
Email clinical_research@med.nagoya-cu.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 C-SHOT1601
Org. issuing International ID_1 Center for Supporting Hematology-Oncology Trials (C-SHOT)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 多施設共同試験

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 20 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 30
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
2016 Year 04 Month 21 Day
Date of IRB
2019 Year 01 Month 07 Day
Anticipated trial start date
2016 Year 04 Month 26 Day
Last follow-up date
2020 Year 09 Month 30 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 04 Month 20 Day
Last modified on
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.