Multiple Myeloma
Conditions
Interventions
Phase I dose-escalation trial of cyclophosphamide which involves three cohorts. Cohort1:lenalidomide 15mg/day (Days 1-21), dexamethasone 40mg/day (Days 1, 8, 15(or 22), cyclophosphamide 200mg/day (
Sponsors
KT-MM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG) 2) Relapsed and refractory myeloma after at least 1 treatment regimen. 3) Aged more than 70 years old 4) Karnofsky performance status more than 70%,(ECOG PS:0-1) 5) Coexisting conditions are eligible as follows: A.bone marrow function; a) neutrophil count; more than 1,000/mm3, b) platelet count; more than 50,000/mm3, c) hemoglobin count; more than 7.0g/dL, B.liver function; a) less than two times of maximum normal value in AST and ALT, b) less than two times of maximum normal value in total bilirubin C.renal function; a) less than two times of maximum normal value in serum creatinine, D.cardiac function; a) no ECG abnormalities (more than 450msec in QTc elongation, any cardiac ischemia and atrial fibrillation and ventricular arrhythmias. b) more than 50% in ejection fraction of left ventricle. E.respiratory function; a) no abnormalities in chest X-ray 6) no severe peripheral neuropathy, neuropathic pain and functional loss (Gr 0, or 1 in NCI-CTCv4.0). 7) In the patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained 8) Male patients who agree to contraception by contraceptive operation or other appropriate method
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose, incidence of adverse events, duration of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Best response rate, duration of response, progression free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactMakoto Sasaki
Juntendo Univ. Division of Hematology
Outcome results
None listed