UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027780
Receipt number R000031494
Scientific Title Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN003 study
Date of disclosure of the study information 2017/06/16
Last modified on 2020/03/31 17:17:44

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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 or person

Institute

EP-CRSU Co.,Ltd

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031494


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name