UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN003 study
Acronym	Randomized study of PCD versus PD in relapse or refractory myeloma. An AMN003 study
Scientific Title	Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN003 study
Scientific Title:Acronym	Randomized study of PCD versus PD in relapse or refractory myeloma. An AMN003 study
Region	Japan Asia(except Japan)

Condition
Condition	Relapse or refractory 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 PCD compared to PD in patients who have relapsed and have previously been treated with bortezomib and lenalidomide.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival (PFS) is defined as the time from commencement of treatment with either PCD or PD to disease progression or death due to any cause, whichever occurs first.
Key secondary outcomes	1) Overall Response Rate (ORR) 2) Overall Survival (OS) 3) Duration of Response (DOR) 4) Safety and Tolerability

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	For PD, Patients will be treated as follows: PO pomalidomide 4mg from D1-21 and PO or IV dexamethasone 40mg D1, 8, 15 and 22 in a 28-day cycle.
Interventions/Control_2	For PCD, they will be treated as follows: PO pomalidomide 4mg from D1-21, PO cyclophosphamide 400m on D1, 8 and 15, and PO or IV dexamethasone 40mg D1, 8, 15 and 22 in a 28-day cycle.
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.Multiplemyeloma,diagnosed accordingto standard criteria,with relapsing and refractory disease at study entry 2.Patients must have evaluable multiplemyeloma with atleast one of the measurable M-protein defined in the protocol 3.Can receive up to 6lines of prior treatment. 4.Must be relapse refractory to prior lenalidomide and bortezomib.Refractoriness is defined as disease progression on treatment or progression within 6months after the last dose of a given therapy. 5.Over 18years 6ECOG PS of 0to2 7.Patients must meet the clinical laboratory criteria defined in the protocol. 8.Female patients who: a.Are naturally postmenopausal for at least 2year before enrolment b.Are surgically sterile c.If they are of childbearing potential,agree to theguidelines of the pomalidomide pregnancy prevention and risk management program 9.Male patients,evenif surgically sterilized,who: a.Agree to practice effective barrier contraception during the entire study treatment period and through 28days after the last dose of study treatment,OR b.Agree to completely abstain from heterosexual intercourse,AND c.Must also adhereto the guidelines of the pomalidomide pregnancy prevention and risk management program 10.Written informed consent in accordance with federal,local and institutional guidelines
Key exclusion criteria	1.Female patients who are lactating or pregnant 2.Multiple Myeloma of IgM subtype 3.Glucocorticoid therapy within14days 4.POEMS syndrome 5.Plasma cell leukemia or circulating plasma cells more than 2x109/L 6.Waldenstrom's Macroglobulinaemia 7.Patients with known amyloidosis 8.Chemotherapy with approved or investigation anticancer therapeutics within21days prior tostarting pomalidomide treatment 9.Focal radiation therapy within7days prior to start of pomalidomide.Radiation therapy to an extended field involving a significant volume of bone marrow within21days prior to start of pomalidomide 10.Immunotherapy 11.Major surgery within28days 12.ActiveCHF, symptomatic is chaemia,or conduction abnormalities. Myocardial infarction within4months prior 13.KnownHIV seropositive,hepatitis C infection,and/or hepatitis B(except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B these patients are allowed) 14.Patients with known cirrhosis 15.Second malignancy within the past3years16.Patients with MDS 17.Patients with steroid or lenalidomide hypersensitivity 18.Prior treatment with pomalidomide 19.OngoingGVHD 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	120

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Handa
Organization	Gunma University
Division name	Department of Hematology
Zip code	371-8511
Address	3-39-15 Showa-chou,Maebashi-shi,371-8511,Japan
TEL	027-220-7111
Email	handahiroshi@gunma-u.ac.jp

Public contact
Name of contact person	1st name Minoru Middle name Last name Ido
Organization	EP-CRSU Co.,Ltd
Division name	Clinical Research Headquarters
Zip code	541-0043
Address	Kogin Bldg.,4-1-1 Koraibashi,Chuo-ku,Osaka,541-0043,Japan
TEL	06-6202-5375
Homepage URL
Email	prj-amn003@eps.co.jp

Sponsor
Institute	EP-CRSU Co.,Ltd
Institute
Department

Funding Source
Organization	international myeloma foundation
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	Gunma university hospital EC
Address	3-39-15 Showa-chou,Maebashi-shi,371-8511,Japan
Tel	027-220-8740
Email	gunmaciru-office@umin.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT03143049
Org. issuing International ID_1	clinical trials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 16 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	11
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	2017 Year 01 Month 15 Day
Date of IRB	2017 Year 06 Month 29 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 16 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031494