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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018405
Receipt No. R000021307
Scientific Title Prospective Follow-up of Relapse Myeloma Patients after Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone
Date of disclosure of the study information 2015/08/01
Last modified on 2019/02/25

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Basic information
Public title Prospective Follow-up of Relapse Myeloma Patients after Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone
Acronym Phase II trial on Pomalidomide and Dexamethazone treatment for relapsed multiple myeloma (AMN001/J-MEN009 (POM-DEX))
Scientific Title Prospective Follow-up of Relapse Myeloma Patients after Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Kosugi
Organization Ogaki municipal Hospital
Division name Department of Hematology
Zip code
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
1st name
Middle name
Last name Yumi Miyashita
Organization NPO Epidemiological and Clinical Research Information Network (ECRIN)
Division name Aichi Branch
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Main results already published
Date of protocol fixation
2015 Year 07 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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