Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
experimental group:dexamethasone 40mg/d, po, 4d
thalidomide 100-200mg/d, D1-4
cis-platinum 10mg/m2, D1-4
liposomal doxorubicin hydrochloride 40 mg/m2, D1
cyclophosphamide 400mg/m2, D1-4
etoposide 40mg/(m2?d), D1-4
decitabine 10mg/d, D1-D5. 4 weeks/cycle, 3cycles in total
control group:dexamethasone 40mg/d, po, 4d
4 weeks/cycle, 3cycles in total
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients have signed the informed consent; 2. aged 18 years to 75 years; 3. By cell morphology and flow cytometry analysis examination diagnosis of patients with multiple myeloma, poor curative effect after standard treatment scheme, a diagnosis of recurrence of refractory multiple myeloma; 4. have measurable multiple myeloma, defined by at least one of the following measurements as per thresholds: (1) Serum M-protein >/=10g/L(serum protein electrophoresis) or IgA >/=7.5g/L (turbidimetric method for quantitative analysis of immunoglobulins); (2) Urine M-protein >/=0.2g/24h; 5. The eastern cooperative oncology group fitness score (ECOG) =1.0*10^9/L; Platelet count >=50*10^9/L; AST/SGOT, ALT/SGPT and ALP =30 ml/min
Exclusion criteria
Exclusion criteria: 1. stem cell transplant recipient presenting with graft versus host disease either active or requiring immunosuppression at time of signing the informed consent; 2. Patients have allergic history or contraindication of any of the interventional drugs; 3. Patients have received any prior routine or experimental anti-myeloma chemotherapy or radiation therapy in 4 weeks prior to start of study, maintenance treatment of thalidomide or lenalidomide and prior limited field radiotherapy should be avoided in 2 weeks prior to start of study; 4. Patients have undergone major surgery within 2 weeks prior to start of study; 5. Patients with plasma cell leukemia; 6. Patients have other cancers; 7. Patients have poorly controlled hypertension or clinically significant (eg, active) cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months before signing the informed consent ), Unstable angina, >=2 congestive heart failure (defined by New York Heart Association classification), or severe arrhythmia uncontrolled by conventional intervention or has potential impact on the treatment of the trial; 8. Patients have other serious organic diseases and mental illness; 9. Patients have systemic active infections that require treatment; 10. Patients with known human immunodeficiency virus seropositivity or active hepatitis A, B or C; 11. Female patients who are pregnant or lactating; 12. Patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;QoL;Adverse reaction rate; | — |
Countries
China
Contacts
Public ContactBaijun Fang
Henan Cancer Hospital
Outcome results
None listed