multiple myeloma
Conditions
Interventions
experimental group:Circular Permuted TRAIL+Thalidomide+Dexamethasone
control group:Placebo+Thalidomide+Dexamethasone
Sponsors
CCMU Beijing Chaoyang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. informed consent signed; 2. To be aged 18 to 75 years at time of signing the informed consent; 3. have received 2 or more prior therapeutic regimens with relapsed or refractory multiple myeloma, and not ready to accept bone marrow transplant; 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. have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of /=1.0*10^9/L; Platelet count(PLT) >/=50*10^9/L; Aspartate aminotransferase (AST/SGOT)/=30ml/min; 8. ensure to comply with the management plan of thalidomide in preventing pregnancy risk.
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. multiple myeloma refractory to TD or TD involved treatment, ie must accordance with at least one of the following conditions after the latest TD or TD involved treatment (>/=2 cycles, dexamethasone >/=120mg per cycle): did not achieve at least a MR, or have progressed under the treatment or within 60 days of last dose; 3. multiple myeloma refractory to RD or RD involved treatment, ie must accordance with at least one of the following conditions after the latest RD or RD involved treatment (>/=2 cycles, dexamethasone >/=120mg per cycle): did not achieve at least a MR, or have progressed under the treatment or within 60 days of last dose; 4. hypersensitivity or intolerate to thalidomide or dexamethasone; 5. has 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 /=2 congestive heart failure, or severe arrhythmia uncontrolled by conventional intervention or has potential impact on the treatment of the trial; 11. with other severe organic disease or psychiatric illness; 12. with systemic active infection requiring treatment; 13. with known human immunodeficiency virus seropositivity or active hepatitis A, B or C; 14. Female patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DOR;TTR;TTP;PRO;Safty; | — |
Countries
China
Contacts
Public ContactShifang Yang
Outcome results
None listed