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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013067
Receipt No. R000015061
Scientific Title Phase I/II trial of subcutaneous bortezomib plus lenalidomide combined with dexamethasone combination therapy for relapsed or refractory multiple myeloma patients
Date of disclosure of the study information 2014/02/08
Last modified on 2019/03/09

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Basic information
Public title Phase I/II trial of subcutaneous bortezomib plus lenalidomide combined with dexamethasone combination therapy for relapsed or refractory multiple myeloma patients
Acronym FBMTG-sVRd14
Scientific Title Phase I/II trial of subcutaneous bortezomib plus lenalidomide combined with dexamethasone combination therapy for relapsed or refractory multiple myeloma patients
Scientific Title:Acronym FBMTG-sVRd14
Region
Japan

Condition
Condition Multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility (phase I) and efficacy (phase II) of a combination of subcutaneous bortezomib, lenalidomide and dexamethasone in patients with multiple myeloma who have relapsed ro refractory to previous therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes 1) Phase I
To determine the maximum tolerated dose (MTD) of subcutaneous bortezomib administrated once weekly, lenalidomide administrated for 3 weeks when combined with dexamethasone in a 28-day schedule.

2) Phase II
To investigate the efficacy of a 8 cycles of subcutaneous bortezomib, lenalidomide and dexamethasone at the recommended dose level determined by the phase I trial.
Key secondary outcomes

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 1) Phase I
The MTD of bortezomib and lenalidomide with dexamethasone will be determined according to a 3 + 3 dose-escalation scheme. The MTD will be evaluated within 2 cycles of treatment.
During the Phase I part of the trial, the dose of lenalidomide will be escalated from 15 (dose level 0) to 25 mg (dose level 2). If dose level 0 is not feasible, then lenalidomide will be added at a dose of 10 mg (dose level -1). Bortezomib will subcutaneously administrated at a dose of 1.3 mg/m2 on days 1, 8 and 15. Dexamethasone will be added orally at a dose of 20 mg on days 1, 8 and 15.

2) Phase II
Lenalidomide will be administrated as an oral formulation at the MTD dose or highest dose if MTD is not reached, days 1-21, followed by a one-week interval. Bortezomib will subcutaneously administrated at a dose of 1.3 mg/m2 on days 1, 8 and 15. Dexamethasone will be added orally at a dose of 20 mg on days 1, 8 and 15. This treatment cycle will repeat at 28-days intervals until a 8 cycles of treatment have been given.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Relapsed or refractory myeloma after at least 1 treatment regimen.

2) Measureable M protein in serum or urine.

3) ECOG performance status of 0 to 2 (Patients with PS 3 restricted by bone lesions are allowed to participate)

4) Age older than 20 years

5) Adequate organ function

6) A life expectancy of at least 3 months

7) Female patients with post menoposal status and the last menstrual period>12 months prior to enrollment in trial, or patients who agree to contraception during the study.

8) Voluntary written informed consen
Key exclusion criteria 1) Peripheral neuropathy and neuropathic pain >=Grade 2(CTCAE ver.4.0).

2) Those who can not receive bortezomib subcutaneously at a dose of 1.3 mg/m2

3) History of hypersensitivity to lenalidomide, bortezomib, dexamethasone, mannitol or boron.

4) Nonsecretory multiple myeloma, solitary plasmacytoma, plasma cell leukemia or POEMS syndrome.

5) Known human immunodeficiency virus (HIV) infection or active hepatitis A, B or C.

6) Serious concurrent uncontrolled medical disorder. (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction diabetes, hypertension and infectious diseases)

7) History of active malignancy during the past 5 years

8) Psychoneurotic disorder, depression state or history

9) Pregnant or lactating female

10) Patients with pneumonia, pulmonary fibrosis or bilateral interstitial abnormalities.

11) Those who are considered as inappropriate to register by attending physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiro Miyamoto
Organization Kyushu University Hospital
Division name Hematology and Oncology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5230
Email toshmiya@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Miyamoto
Organization Fukuoka Blood and Marrow Transplantation Group
Division name RRMM-sVRd14 DC
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5229
Homepage URL
Email fbmtg@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute Fukuoka Blood and Marrow Transplantation Group
Institute
Department

Funding Source
Organization Fukuoka Blood and Marrow Transplantation Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 08 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 Completed
Date of protocol fixation
2014 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 04 Day
Last modified on
2019 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015061

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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