UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022008
Receipt number 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 2021/04/26 11:03:01

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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 or person

Institute

Nagoya City University Hospital

Division of Hematology & Oncology

Institute

Department

Personal name



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

Partially published


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

2020 Year 10 Month 01 Day

Date trial data considered complete

2020 Year 10 Month 31 Day

Date analysis concluded

2020 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 20 Day

Last modified on

2021 Year 04 Month 26 Day



Link to view the page

Value
https://center6.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