Bortezomib-based Optimized therapy Aiming Disease control in Japa
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000007335
- Lead Sponsor
- Saitama Medical Center, Saitama Medical University
- Brief Summary
*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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 168
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidents of adverse events
- Secondary Outcome Measures
Name Time Method Best response rate,Time to progression