UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of lenalidomide cyclophosphamide and dexamethasone (RCd) therapy in Japanese elderly patients with multiple myeloma, a phase I/II study
Acronym	RefLEX-study Therapy for Refractory or relapsed elderly myeloma with Lenalidomide, cyclophosphamide (Endoxan) and deXamethasone.
Scientific Title	Safety and efficacy of lenalidomide cyclophosphamide and dexamethasone (RCd) therapy in Japanese elderly patients with multiple myeloma, a phase I/II study
Scientific Title:Acronym	RefLEX-study Therapy for Refractory or relapsed elderly myeloma with Lenalidomide, cyclophosphamide (Endoxan) and deXamethasone.
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 safety and efficacy of the combination therapy with lenalidomide, cyclophosphamide, and dexamethasone as induction therapy for relapsed or refractory geriatric multiple myeloma patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Maximum tolerated dose, incidence of adverse events, duration of therapy
Key secondary outcomes	Best response rate, duration of response, progression free survival, overall survival

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	Phase I dose-escalation trial of cyclophosphamide which involves three cohorts. Cohort1:lenalidomide 15mg/day (Days 1-21), dexamethasone 40mg/day (Days 1, 8, 15(or 22), cyclophosphamide 200mg/day (Days 1, 8, 15, 22)) Cohort2: lenalidomide 15mg/day (Days 1-21), dexamethasone 40mg/day (Days 1, 8, 15(or 22), cyclophosphamide 300mg/day (Days 1, 8, 15, 22)) Cohort3: lenalidomide 15mg/day (Days 1-21), dexamethasone 40mg/day (Days 1, 8, 15(or 22), cyclophosphamide 400mg/day (Days 1, 8, 15, 22)) every five weeks, two to six 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	1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG) 2) Relapsed and refractory myeloma after at least 1 treatment regimen. 3) Aged more than 70 years old 4) Karnofsky performance status more than 70%,(ECOG PS:0-1) 5) Coexisting conditions are eligible as follows: A.bone marrow function; a) neutrophil count; more than 1,000/mm3, b) platelet count; more than 50,000/mm3, c) hemoglobin count; more than 7.0g/dL, B.liver function; a) less than two times of maximum normal value in AST and ALT, b) less than two times of maximum normal value in total bilirubin C.renal function; a) less than two times of maximum normal value in serum creatinine, D.cardiac function; a) no ECG abnormalities (more than 450msec in QTc elongation, any cardiac ischemia and atrial fibrillation and ventricular arrhythmias. b) more than 50% in ejection fraction of left ventricle. E.respiratory function; a) no abnormalities in chest X-ray 6) no severe peripheral neuropathy, neuropathic pain and functional loss (Gr 0, or 1 in NCI-CTCv4.0). 7) In the patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained 8) Male patients who agree to contraception by contraceptive operation or other appropriate method
Key exclusion criteria	1) untreated patients without a history of pretreatment 2) patients with a past history of allergy to the drugs described in the protocol 3) patients with a past history of using lenalidomide 4) patients who are expected to be need radiation against local disease or for palliative therapy, at registration. 5) patients who have any amyloidosis 6) patients who have uncontrollable diabetes mellitus 7) patients with a past history of angina or myocardial infarction and who have arrhythmia treated with anti-arrhythmic. 8) patients with a past history of cerebral infarction. 9) patients with a past history of venous or arterial thrombosis. 10) patients who have or suspected of having a serious active infection 11) patients who have renal failure, requiring hemodialysis. 12) patients who have liver cirrhosis, diagnosed biopsy or clinical data. 13) patients who have had a complication of active double cancer* within the past 5 years * Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment or lesions corresponding to intramucosal carcinoma (excluding cervical carcinoma presenting in FIGO Stage I) 14) positive test for HBs antigen or HCV antibody or HIV antibody. 15) patients who use major tranquilizer, antidepressant, or antimanic drugs. 16) patients who have serious mental disorders such as schizophrenia 17) other patients who are in the opinion of the caring investigator, unfit for enrollment in the study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Sasaki
Organization	Juntendo Univ.
Division name	Division of Hematology
Zip code
Address	Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	msasaki@juntendo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Sasaki
Organization	Juntendo Univ.
Division name	Division of Hematology
Zip code
Address	Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	msasaki@juntendo.ac.jp

Sponsor
Institute	KT-MM
Institute
Department

Funding Source
Organization	Ibaraki Hematology, Oncology & Palliation Expert Meeting(IB-HOPE)
Organization
Division
Category of Funding Organization	Non profit foundation
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	2012 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2012 Year 03 Month 20 Day
Date of IRB	2013 Year 01 Month 25 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 18 Day
Date trial data considered complete	2019 Year 01 Month 20 Day
Date analysis concluded	2019 Year 02 Month 06 Day

Other
Other related information

Management information
Registered date	2012 Year 11 Month 23 Day
Last modified on	2019 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010590