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 | 2024/04/28 11:53:18 |
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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
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
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
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
https://www.ncbi.nlm.nih.gov/pubmed/35699890 https://link.springer.com/article/10.1007/s12185-022-03
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/35699890 https://link.springer.com/article/10.1007/s12185-022-03
Number of participants that the trial has enrolled
30
Results
Modified BLd regimen showed a favorable response rate (60% of PR or better), and well tolerability of modified BLd regimen with less non-hematological toxicities and occurrence of PN. Thus, we concluded that the trial therapy was effective. This study supports the front-line therapy using a proteasome inhibitor and immunomodulatory drugs for the elderly or unfit/frail patients with MM in a transplant-ineligible setting.
Results date posted
| 2024 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N=30
Median age 72
PS0 11 PS1 14 PS2-4 5
Male 14 Female 16
IgG 9IgA 9BJP 4
Participant flow
Enrollment n=30
Starting the therapy n=30
Stopped the therapy n=17 Progressive disease n=9,Adverse events n=5, Refused further therapy n=2, Other(Physician's decision) n=1
Completed therapy n=13
Adverse events
There were 9 serious adverse events, and 4 cases of infectious disease were observed. No treatment-related deaths were observed. Recovery has been confirmed for all of the adverse events.
AEs related to hematological events were highly obsereved. Non-hematological AEs were as follows; fever (26.7%), hyperglycemia (26.7%), and skin disorder (23.3%).
Outcome measures
Primary endpoint
Response rate VGPR or better 60%
Secondary endpoint
Response rate
CR 26.7% PR or better 96.7%
3 yr PFS: 27.6% 95%CI 13.1-44.3%
3 yr OS: 65.5% 95%CI 45.4-79.7%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025358
