Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Single Group:Lenalidomide+dexamethasone
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 18 to 70 years, and voluntery to participate and signed informed consent form; 2. Meet the diagnosis criteria of MM on the stage of DSII or III, and relapsed after at least two cycles of first line chemotherapy, or progressed after or refractory to the last therapy (at least 2 cycles); 3. The patients are with "measurable disease" (serum M protein >=0.5g/dL and / or 24-hour urine M protein >=0.2g); 4. expected survival of more than three months; 5. The eastern cooperative oncology group fitness score (ECOG) <=2 points; 6. Female subjects with fertility within 28 days prior to enrollment or after drug withdrawal and during the trial agree to take reliable contraceptive measures. Pregnancy test must be negative twice, firstly taken within 10-14 days prior to take lenalidomide, secondly taken within 24 hours prior to take lenalidomide. Subjects must agree to accept pregnancy test during the study, treatment time and within at least 28 days after drug withdrawal; 7. if the spouses of male subjects have fertility, agreed to use latex condoms for contraception (Even subjects with vasectomy are no exception), and agreed not to donate sperm or sperm during the study,treatment time and within at least 28 days after drug withdrawal.
Exclusion criteria
Exclusion criteria: 1. unwilling to take effective contraception; 2. Non-secretory MM (M-protein or free light chain not measurable); 3. pregnancy or breast-feeding women; 4. ANC3 times the upper limit of normal,serum total bilirubin>34umol/L(2.0 mg/dL); 6. Over the past six months had a serious cardiovascular disease, including surgical treatment of angina pectoris, poorly controlled hypertension after antihypertensive treatment (systolic blood pressure>160mmHg, diastolic blood pressure>90mmHg), Myocardial infarction, Level II-IV congestive heart failure, unstable angina; 7. renal failure needing for hemodialysis or peritoneal dialysis; 8. History of other tumors, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin,or history of carcinoma in situ of the cervix or breast; 9. the patients are on thalidomide or dexamethasone allergies; 10. in the past dexamethasone treatment has a history of uncontrollable side effects; 11. the patients appear peripheral neuropathy with two or more degree; 12. used lenalidomide before screening; 13. patients receiving any other antimyeloma drugs within 28 days prior to enrollment,or receiving any other non-drug therapy(such as leukocyte /mononuclear cells infusion); 14. unable or unwilling to accept the antithrombotic therapy; 15. Over the past 12 months has a history of deep venous thrombosis or pulmonary embolism; 16. HIV positive; 17. Subjects with Hepatitis A, B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DOR; | — |
Countries
China
Contacts
Public ContactJian Hou
Shanghai Changzheng Hospital
Outcome results
None listed