UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II trial of subcutaneous bortezomib plus lenalidomide combined with dexamethasone combination therapy for relapsed or refractory multiple myeloma patients
Title of the study (Brief title)	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	Toshihiro Miyamoto
Organization	Kyushu University Hospital
Division name	Hematology and Oncology
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	Toshihiro Miyamoto
Organization	Fukuoka Blood and Marrow Transplantation Group
Division name	RRMM-sVRd14 DC
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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