Safety and efficacy of lenalidomide cyclophosphamide and dexamethasone (RCd) therapy in Japanese elderly patients with multiple myeloma, a phase I/II study
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-UMIN000009391
- Lead Sponsor
- KT-MM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) untreated patients without a history of pretreatment 2) patients with a past history of allergy to the drugs described in the protocol 3) patients with a past history of using lenalidomide 4) patients who are expected to be need radiation against local disease or for palliative therapy, at registration. 5) patients who have any amyloidosis 6) patients who have uncontrollable diabetes mellitus 7) patients with a past history of angina or myocardial infarction and who have arrhythmia treated with anti-arrhythmic. 8) patients with a past history of cerebral infarction. 9) patients with a past history of venous or arterial thrombosis. 10) patients who have or suspected of having a serious active infection 11) patients who have renal failure, requiring hemodialysis. 12) patients who have liver cirrhosis, diagnosed biopsy or clinical data. 13) 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) 14) positive test for HBs antigen or HCV antibody or HIV antibody. 15) patients who use major tranquilizer, antidepressant, or antimanic drugs. 16) patients who have serious mental disorders such as schizophrenia 17) 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 Maximum tolerated dose, incidence of adverse events, duration of therapy
- Secondary Outcome Measures
Name Time Method Best response rate, duration of response, progression free survival, overall survival