Unique ID issued by UMIN | UMIN000007335 |
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Receipt number | R000008594 |
Scientific Title | Bortezomib-based Optimized therapy Aiming Disease control in Japan |
Date of disclosure of the study information | 2012/02/20 |
Last modified on | 2013/08/23 12:28:17 |
Bortezomib-based Optimized therapy
Aiming Disease control in Japan
BoRtezomib-based Optimized therapy
Aiming Disease control in Japan
: BROAD-J Study
Bortezomib-based Optimized therapy
Aiming Disease control in Japan
BoRtezomib-based Optimized therapy
Aiming Disease control in Japan
: BROAD-J Study
Japan |
Multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
To investigate the efficacy, safety and the time to treatment failure of Bortezomib as induction and maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation.
Safety,Efficacy
Incidents of adverse events
Best response rate,Time to progression
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bortezomib(1.3m/m2,days 1,8,15,22),Melphalan(6mg/m2,days 1-4) and prednisone(40mg/m2,days 1-4) administered for four 35-day cycles as induction therapy,followed by Bortezomib(1.3mg/m2,day1,15) administered for 28-day cycles until relapse as maintenance therapy.
20 | years-old | <= |
Not applicable |
Male and Female
(1)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG)
(2)untreated patients without a history of pretreatment, excluding local radiotherapy from pretreatment
(3)untreated multiple myeloma patients who diagnosed ineligible for autologous stem cell transplantation at induction therapy
(4)aged more than 20 years old
(5)performance status:0-2,or 3 due to osteolytic lesions alone
(6)coexisting conditions are eligible as follows:
neutrophil count; more than 1,000/mm3,platelet count; more than 50,000/mm3,hemoglobin count; more than 7.0g/dL
(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.
(1)Patients with a past history of allergy to the drug described in the protocol
(2)Patients who have had a complication of active double cancer* within the past 5 years * Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment or lesions corresponding to intramucosal carcinoma (excluding cervical carcinoma presenting in FIGO Stage I)
(3)HBs antigen,or HCV 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 X-ray scan regardless of the presence or absence of symptoms
(6) Patients who have or suspected of having a serious active infection
(7) Patients with serious pulmonary dysfunction
(8) Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment
(9)The serum AST value and ALT value is more than 2.5 times from a facilities upper limit
(10)The serum total bilirubin value is more than 2.0 times from a facilities upper limit
(11)Patients with grade 2 or severer peripheral neuropathy
(12)Women who are or may be pregnant
(13)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
168
1st name | |
Middle name | |
Last name | Masahiro Kizaki |
Saitama Medical Center,Saitama Medical University
Department of Hematology
1981,Kamoda,Kawagoe-shi,Saitama,
049-228-3471
info@broadj.org
1st name | |
Middle name | |
Last name | Kenshi Suzuki |
Japanese Red Cross Medical Center
Department of Hematology
4-1-22,Hiroo,Shibuya-ku,Tokyo,
03-3400-1311
info2@broadj.org
Saitama Medical Center, Saitama Medical University
None
Self funding
NO
2012 | Year | 02 | Month | 20 | Day |
Partially published
*We conducted p2 study, BROAD-J study, based on a weekly MPB as induction therapy followed by Bor-MT as every two weeks or a month administration for newly-diagnosed ineligible MM patients.
*We performed an interim analysis of 77 pts who were able to be estimated.
* Mean age was 73.8 years(60-86), and sex ratio was 41:36(M:F).
*The subtypes of MM were IgG 46, IgA 11, IgD 1 and BJP 17, and ISS was I 15, II 32, and III 30.
*Sixty pts(77.9%) are still on the study(26 pts on MPB phase and 34 pts on Bor-MT phase), while 17 pts were discontinued mainly because of PD(10 pts) and AEs(5 pts).
*The mean MPB cycles of all pts were 3.3(1-9), and 34% of pts achieved VGPR and more.
*In MPB phase, 33.4% of pts showed>=grade 3 AEs, whereas only 5.8% had >=grade 3 AEs in Bor-MT phase.
*Seventy-three pts of all pts(94.8%) were alive at the writing time, and 4 pts were dead: 2 pts were dead due to PD, 1 pt was due to dissecting aortic aneurysm, and 1pt was due to severe bacterial infection.
Completed
2011 | Year | 10 | Month | 15 | Day |
2011 | Year | 12 | Month | 01 | Day |
2015 | Year | 02 | Month | 10 | Day |
2015 | Year | 02 | Month | 11 | Day |
2015 | Year | 02 | Month | 11 | Day |
2015 | Year | 08 | Month | 01 | Day |
2012 | Year | 02 | Month | 20 | Day |
2013 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008594
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