Unique ID issued by UMIN | UMIN000013467 |
---|---|
Receipt number | R000015621 |
Scientific Title | Phase 2 study to evaluate the efficacy and the safety of clarithromycin, lenalidomide and dexamethasone (Personalized BiRd) for patients with relapsed or refractory multiple myeloma |
Date of disclosure of the study information | 2014/03/20 |
Last modified on | 2020/01/04 01:11:57 |
Phase 2 study to evaluate the efficacy and the safety of clarithromycin, lenalidomide and dexamethasone (Personalized BiRd) for patients with relapsed or refractory multiple myeloma
Personalized BiRd for relapsed or refractory multiple myeloma
Phase 2 study to evaluate the efficacy and the safety of clarithromycin, lenalidomide and dexamethasone (Personalized BiRd) for patients with relapsed or refractory multiple myeloma
Personalized BiRd for relapsed or refractory multiple myeloma
Japan |
multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of BiRd therapy for relapsed or refractory multiple myeloma patients
Safety,Efficacy
Confirmatory
Phase II
Best response rate
Safety
Incidence of adverse events
Incidence of infection
Progression free survival
Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
<Personalized BiRd>
Clarithromycin 200mg x 2/day(Day1-28) p.o
Lenalidomide 5-25mg/day(Day1-21) p.o
Dexamethasone 20-40mg/day(Day1, 8, 15, 22) p.o
*VES-13(Vulnerable Elders Survey-13)
VES-13 is performed before the start of the study to evaluate frailty.
Lenalidomide dosage is adjusted according to VES-13 score and renal function.
[VES-13 score<3] (Fit)
<Lenalidomide>
CCr>60ml/min
Lenalidomide 25mg/body once daily
30<CCr<60ml/min
Lenalidomide 15mg/body once daily
CCr<30ml/min
Lenalidomide 15mg/body every other day
<Dexamethasone>
40mg/day weekly
[VES-13 score>=3] (Frail)
<Lenalidomide>
CCr>60ml/min
Lenalidomide 15mg/body once daily
30<CCr<60ml/min
Lenalidomide 10mg/body once daily
CCr<30ml/min
Lenalidomide 5mg/body once daily
<Dexamethasone>
20mg/day weekly
20 | years-old | <= |
Not applicable |
Male and Female
(1)aged more than 20 years old
(2)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG)
(3)relapsed or refractory cases after at least one prior chemotherapy
(4)having measurable paraprotein
(5)performance status:0-2,or 3 due to osteolytic lesions alone
(6)coexisting conditions are eligible as follows:
1)neutrophil count; more than 1,000/mm3
2)platelet count; more than 75,000/mm3
3)serum AST, ALT< 5 times the ULN
4)serum T-Bil< 3 times the ULN
5)serum Cr< 3 times the ULN
6)ejection fraction >= 50%
(7)Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method
(8)Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.
(9)patients who are observed RevMate
(1) Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 2 or more.
(2)Patients who have had a complication of active double cancer within the past 5 years.
(3)HBs antigen positive,HCV antibody positive, HIV antibody positive patients
(4) serious mental disorders such as schizophrenia
(5) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms
(6) Patients with severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection
(7)Patients with plasma cell leukemia, cardiac amyloidosis and POEMS syndrome
(8)Ptients with thrombosis
(9)Women who are or may be pregnant
(10)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
20
1st name | Tomonori |
Middle name | |
Last name | Nakazato |
Yokohama Municipal Citizen's Hospital
Department of Hematology
2408555
56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa
045-331-1961
n-tomo@eurus.dti.ne.jp
1st name | Tomonori |
Middle name | |
Last name | Nakazato |
Yokohama Municipal Citizen's Hospital
Department of Hematology
2408555
56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa
045-331-1961
n-tomo@eurus.dti.ne.jp
Yokohama Municipal Citizen's Hospital
None
Self funding
Yokohama Municipal Citizen's Hospital
56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan
0453311961
ke06-fukushima@city.yokohama.jp
NO
2014 | Year | 03 | Month | 20 | Day |
Unpublished
12
Terminated
2014 | Year | 03 | Month | 17 | Day |
2014 | Year | 02 | Month | 16 | Day |
2014 | Year | 03 | Month | 20 | Day |
2020 | Year | 02 | Month | 20 | Day |
2014 | Year | 03 | Month | 19 | Day |
2020 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015621
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |