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
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000013467
- Lead Sponsor
- Yokohama Municipal Citizen's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best response rate
- Secondary Outcome Measures
Name Time Method Safety Incidence of adverse events Incidence of infection Progression free survival Overall survival