UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018405 |
|---|---|
| Receipt number | 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 14:24:55 |
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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
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
miya@ecrin.or.jp
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021307
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