UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013067 |
|---|---|
| Receipt number | 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 10:51:49 |
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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
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
fbmtg@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka Blood and Marrow Transplantation Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015061
