UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Follow-up of Relapse Myeloma Patients after Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone
Title of the study (Brief title)	Phase II trial on Pomalidomide and Dexamethazone treatment for relapsed multiple myeloma (AMN001/J-MEN009 (POM-DEX))
Region	Japan Asia(except Japan)

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

Objectives
Narrative objectives1	To assess the progression free survival (PFS) for pomalidomide and dexamethasone in patients who have relapsed and are refractory to lenalidomide and have previously been treated with bortezomib.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	o assess the progression free survival (PFS) for pomalidomide and dexamethasone in patients who have relapsed and are refractory to lenalidomide and have previously been treated with bortezomib.
Key secondary outcomes	(1)Overall Response Rate (ORR) (2)To see if addition of cyclophosphamide will induce additional response in patient who do not achieve an minimal response (MR) after 3 months (3)Overall Survival (OS) (4)Duration of Response (DOR) (5)Safety and Tolerability

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	The treatment schema is summarized in the figure below. Patients will be treated with the pomalidomide schedule that is approved by the FDA and EMA. PO pomalidomide 4mg from D1-21 and PO or IV dexamethasone 40mg D1, 8, 15 and 22 in a 28-day cycle. PO or IV cyclophosphamide 300mg/m2 on D1, 8 and 15 can be added at the discretion of the treating physician to induce added response under the following circumstances: 1) If there is less than a MR after 3 cycles in the absence of disease progression, or 2) If there is disease progression within the first 3 cycles of Pomalidomide and Dexamethasone treatment.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Multiple myeloma with relapsing and refractory disease at study entry 2) Patients must have evaluable multiple myeloma with at least one of the measurable M-protein defined in the protocol. 3) Can receive up to 6 lines of prior treatment. 4) Must have failed lenalidomide (based on 1 of the following criteria, a) Refractory to lenalidomide, or b) no better than stable disease after 3 cycles of lenalidomide) and relapsed from previous treatment with bortezomib. 5) Over 18 years. 6) ECOG PS of 0 to 2 7) Patients must meet the clinical laboratory criteria defined in the protocol. 8) Female patients who are naturally postmenopausal for at least 2 year before enrolment or surgically sterile or agree to adhere to the pomalidomide pregnancy prevention risk management program if childbearing potential. 9) Male patients who agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse, AND must also adhere to the guidelines of the pomalidomide pregnancy prevention and risk management program 10) Written informed consent.
Key exclusion criteria	1)Female patients who are lactating or pregnant 2)Multiple Myeloma of IgM subtype 3)Glucocorticoid therapy within 14 days 4)POEMS syndrome 5)Plasma cell leukemia or circulating plasma cells more than 2 x 109/L 6)Macroglobulinaemia 7)Known amyloidosis 8)Chemotherapy with anticancer therapeutics within 21 days prior to starting pomalidomide treatment 9)Focal radiation therapy or radiation therapy to an extended field. 10)Immunotherapy 11)Major surgery within 28 days 12)Active CHF, symptomatic ischaemia, or conduction abnormalities. Myocardial infarction within 4 months prior. 13)Known HIV, HCV, HBV-positivity. (except for patients with HBs-Ag or HBc-Ab responding to antiviral therapy: these patients are allowed) 14) Known cirrhosis 15)Second malignancy within the past 3 years. 16)Patients with MDS 17)Patients with steroid or lenalidomide hypersensitivity 18)Prior treatment with pomalidomide 19)Ongoing GVHD 20)Patients with pleural effusions or ascites 21)Contraindication to any of the required concomitant drugs or supportive treatments 22)Any clinically significant medical disease or psychiatric condition.
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroshi Kosugi
Organization	Ogaki municipal Hospital
Division name	Department of Hematology
Address	4-86 Minaminokawa-chou, Ogaki, 503-8502 JAPAN
TEL	0584-81-3341
Email	h-kosugi@umin.ac.jp

Public contact
Name of contact person	Yumi Miyashita
Organization	NPO Epidemiological and Clinical Research Information Network (ECRIN)
Division name	Aichi Branch
Address	1-7-9 Hane-Nishi
TEL	0564-64-7300
Homepage URL	http://www.ogaki-mh.jp/chiken/kenkyu.html
Email	miya@ecrin.or.jp

Sponsor
Institute	NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization	NPO Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	JAPAN

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

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02158702
Org. issuing International ID_1	A service of the U.S. National Institutes of Health clinicaltrials.gov.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大垣市民病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 07 Month 04 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry	2018 Year 05 Month 17 Day
Date trial data considered complete	2018 Year 06 Month 14 Day
Date analysis concluded	2019 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 24 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021307