Unique ID issued by UMIN | UMIN000027780 |
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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 |
Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN003 study
Randomized study of PCD versus PD in relapse or refractory myeloma. An AMN003 study
Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN003 study
Randomized study of PCD versus PD in relapse or refractory myeloma. An AMN003 study
Japan | Asia(except Japan) |
Relapse or refractory myeloma
Hematology and clinical oncology |
Malignancy
NO
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.
Safety,Efficacy
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.
1) Overall Response Rate (ORR)
2) Overall Survival (OS)
3) Duration of Response (DOR)
4) Safety and Tolerability
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
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.
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.
18 | years-old | <= |
Not applicable |
Male and Female
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
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
120
1st name | Hiroshi |
Middle name | |
Last name | Handa |
Gunma University
Department of Hematology
371-8511
3-39-15 Showa-chou,Maebashi-shi,371-8511,Japan
027-220-7111
handahiroshi@gunma-u.ac.jp
1st name | Minoru |
Middle name | |
Last name | Ido |
EP-CRSU Co.,Ltd
Clinical Research Headquarters
541-0043
Kogin Bldg.,4-1-1 Koraibashi,Chuo-ku,Osaka,541-0043,Japan
06-6202-5375
prj-amn003@eps.co.jp
EP-CRSU Co.,Ltd
international myeloma foundation
Non profit foundation
Gunma university hospital EC
3-39-15 Showa-chou,Maebashi-shi,371-8511,Japan
027-220-8740
gunmaciru-office@umin.ac.jp
YES
NCT03143049
clinical trials.gov
2017 | Year | 06 | Month | 16 | Day |
Unpublished
11
Completed
2017 | Year | 01 | Month | 15 | Day |
2017 | Year | 06 | Month | 29 | Day |
2017 | Year | 07 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2017 | Year | 06 | Month | 16 | Day |
2020 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031494
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