UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study to validate the efficacy on the induction, consolidation, and maintenance therapy for the elderly multiple myeloma patients.
Title of the study (Brief title)	Teikyo elderly MM study
Region	Japan

Condition
Condition	Multiple myeloma patients over the age of 70.
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We validate that the induction, consolidation, and maintenance therapy with adjusting dose, schedule, and route of administration of four drug-combinations (Bortezomib, Lenalidomide, Thalidomide, Dexamethasone) improve efficacy and safely for multiple myeloma patients aged over 70.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Efficacy at the end of two sequential induction therapies Efficacy includes over-all response rate, VGPR and above CR ratio by IMWG uniform response criteria.
Key secondary outcomes	Safety profile of induction, consolidation, and maintenance therapy, rate of continuation in maintenance therapy, improvement of efficacy during consolidation and maintenance therapy, progression free survival, prognosis of 75 years of age or older

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1st induction therapy Bortezomib 1.0 mg/m2 on days 1, 8, 15, and 22 injected subcutaneously (sc) Dexamethasone 8 mg/body on days 1, 8, 15, and 22 per os (po) or intravenous drip-injection (div) 1st cycle for 35days 2nd induction therapy Bortezomib 1.0 mg/m2 on days 1, 8, 15, and 22 sc Dexamethasone 8 mg/body on days 1, 8, 15, and 22 po or div Lenalidomide 10 mg/body on days 1, 8, 15, and 22 po One cycle for 5 weeks' interval, 3 cycles Consolidation and maintenance Bortezomib 1.0 mg/m2 on days 1, and 15 sc Thalidomide 50 mg/body every other day po One cycle for 5 weeks' interval, 6 cycles
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients are eligible who are diagnosed as a symptomatic (active) MM referred to International Myeloma Working Group (IMWG) criteria, and 1. There are no pre-treated MM therapies without steroid administration or radiation therapy due to hyper calcemia or relieving symptoms. 2. Age at 70 years old or older 3. Karnofsky performance status > 50%(PS 0-2). If patients with PS 3 or 4 or KS >20% patients induced of fructure only, can enroll in this study. 4. Laboratory data 1) Absolute neutrophil count > 1,000 /mm3 2) Platelet count > 50,000 /mm3 3) Hb > 7.0 g/dL 4) AST, ALT < 5 times the ULN 5) T-Bil < 3 times the ULN 6) Cr < 2.5 mg/dL 5. No dysfunctions due to a symptomatic pre-existing sensory neuropathy NCICTC grade 3-4 6. In the case of women, after menopause, surgical contraception or patients who are not willing to use birth control during the study. 7. can comply to register (Lenalidomide, Thalidomide drug management program) to RevMate, TERMS
Key exclusion criteria	Patients who are not eligible for this study are: 1. may be pregnant or are pregnant. 2. suffered from an active cancer within the last five years. 3. HBs antigen positive, HCV-antibody positive, HIV-antibody positive 4. severe psychometric dysfunction 5. with interstitial pneumonitis 6. with a severe active infection 7. with a severe pulmonary dysfunction; PaO2/FiO2 ratio <200 8. with a severe cardiac dysfunction; percent fractional shortening <15% 9. judged unsuitable by the doctor 10. cannot take an oral administration.
Target sample size	24

Research contact person
Name of lead principal investigator	Shirasaki Ryosuke
Organization	University of Teikyo School of Medicine
Division name	Internal medicine, department of Hematology/Oncology
Address	2-11-1 Kaga Itabashi-ku Tokyo
TEL	0339641211
Email

Public contact
Name of contact person	Shirasaki Ryosuke
Organization	University of Teikyo School of Medicine
Division name	Internal medicine, department of Hematology/Oncology
Address
TEL
Homepage URL
Email	ryosuke@med.teikyo-u.ac.jp

Sponsor
Institute	University of Teikyo School of Medicine, Internal medicine, department of Hematology/Oncology
Institute
Department

Funding Source
Organization	University of Teikyo School of Medicine, Internal medicine, department of Hematology/Oncology
Organization
Division
Category of Funding Organization	Self funding
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	帝京大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 05 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 02 Day
Last follow-up date	2016 Year 03 Month 30 Day
Date of closure to data entry	2016 Year 03 Month 30 Day
Date trial data considered complete	2016 Year 03 Month 30 Day
Date analysis concluded	2016 Year 03 Month 30 Day

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

Management information
Registered date	2013 Year 06 Month 01 Day
Last modified on	2018 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012531