Multiple Myeloma
Conditions
Interventions
Case series:Thalidomide, Clarithromycin and Dexamethasone
Sponsors
Bejing Chaoyang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old, not available or acceptable for transplantation; 2. Expected survival more than 6 months; 3. Newly diagnosed symptomatic multiple myeloma (stage IB, II and III); 4. Signed informed consent form; 5. Contraception methods are needed for females in child bearing period and males.
Exclusion criteria
Exclusion criteria: 1. Karnofsky performance status lower than 60; 2. Serum AST or ALT more than triple of the upper limit; serum total bilirubin more than double of the upper limit; 3. Serum platelet count lower than 50×10^9/L; 4. Serum hemoglobin lower than 60g/L; 5. Serum neutrophils count lower than 0.75×10^9/L; 6. Creatinine clearance rate lower than 30ml/min; 7. Grade 2 or higher peripheral neuropathy; 8. Plan for hematopoietic stem cell transplantation within 18 months; 9. Received plasmapheresis within one week before enrolling; 10. Hypersensitivity to thalidomide, clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics; 11. A history of severe or uncontrolled cardiovascular disease, including myocardial infarction, grade II to IV cardiac insufficiency, uncontrolled angina, pericardial disease or cardiac amyloidosis; 12. Females in pregnancy or lactation; 13. Unwilling or unable to take contraception methods (for females in child bearing period and males); 14. Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with very good partial remission (VGPR) or better; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of paticipants with MRD negative;Overall response rate;Progression free survival;Overall survival;Quality of life;Toxicity; | — |
Countries
China
Contacts
Public ContactWen Gao
Bejing Chaoyang Hospital
Outcome results
None listed