Multiple myeloma
Conditions
Interventions
1:Pomalidomide plus low-dose dexamethasone
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients was judged to Symptomatic multiple myeloma on the basis of guidelines for the diagnosis and treatment of multiple myeloma in China in 2015; 2. Eligible patients with RRMM were aged 18 years; 3. Patients had to be refractory to their previous treatment judged to have refractory or relapsed and refractory multiple myeloma; had to have received at least two previous consecutive cycles of bortezomib and lenalidomide, alone or in combination; 4. patients with measurable M protein, that is, at least one of the following 3 determinations: The serum M protein is more than 0.5g/dL (5g/L); The urine M protein is more than 200mg/24h; The determination of serum free light chain in serum free light chain ratio in exceptional circumstances, the involvement of free light chain levels greater than 10mg/dL (100 mg/L). 5. hematology meets the following conditions: ANC = 1 * 10^9/L (including under the support of G-CSF ANC = 1 * 109/L), more than 50% bone marrow plasma cells, neutrophil count not specific requirements; PLT =50 * 10^9/L, more than 50% of the patients with bone marrow plasma cells, platelets can be selected over 30 * 10^9/L; 6. liver and kidney function meet the following conditions: TBIL=2.0mg/dLALTAST=3.0×ULN, serum creatinine =3.0mg/dL or creatinine clearance rate =30ml/min; 7. Antithrombotic drugs such as low molecular heparin sodium or aspirin can be accepted; 8. ECOG 0~2, expected survival of more than 3 months; 9. The washout period from the last treatment (not including dexamethasone)is over two weeks (14 days); 10. has signed the informed consent form.;Inclusion criteria: 1. Patients was judged to Symptomatic multiple myeloma on the basis of guidelines for the diagnosis and treatment of multiple myeloma in China in 2015; 2. Eligible patients with RRMM were aged 18 years; 3. Patients had to be refractory to their previous treatment judged to have refractory or relapsed and refractory multiple myeloma; had to have received at least two previous consecutive cycles of bortezomib and lenalidomide, alone or in combination; 4. patients with measurable M protein, that is, at least one of the following 3 determinations: The serum M protein is more than 0.5g/dL (5g/L); The urine M protein is more than 200mg/24h; The determination of serum free light chain in serum free light chain ratio in exceptional circumstances, the involvement of free light chain levels greater than 10mg/dL (100 mg/L). 5. hematology meets the following conditions: ANC = 1 * 10^9/L (including under the support of G-CSF ANC = 1 * 109/L), more than 50% bone marrow plasma cells, neutrophil count not specific requirements; PLT =50 * 10^9/L, more than 50% of the patients with bone marrow plasma cells, platelets can be selected over 30 * 10^9/L; 6. liver and kidney function meet the following conditions: TBIL=2.0mg/dLALTAST=3.0×ULN, serum creatinine =3.0mg/dL or creatinine clearance rate =30ml/min; 7. Antithrombotic drugs such as low molecular heparin sodium or aspirin can be accepted; 8. ECOG 0~2, expected survival of more than 3 months; 9. The washout period from the last treatment (not including dexamethasone)is over two weeks (14 days); 10. has signed the informed consent form.;Inclusion criteria: 1. Patients was judged to Symptomatic multiple myeloma on the basis of guidelines for the diagnosis and treatment of multiple myeloma in China in 2015; 2. Eligible patients with RRMM were aged 18 years; 3. Patients had to be refractory to their previous treatment judged to have refractory or relapsed and refractory multiple myeloma; had to have received at least two previous consecutive cycles of bortezomib and lenalidomide, alone or in combination; 4. patients with measurable M protein, that is, at least one of the following 3 determinations: The serum M protein is more than 0.5g/dL (5g/L); The urine M protein is more than 200mg/24h; The determination of serum free light chain in serum free light chain ratio in exceptional circumstances, the involvement of free light chain levels greater than 10mg/dL (100 mg/L). 5. hematology meets the following conditions: ANC = 1 * 10^9/L (including under the support of G-CSF ANC = 1 * 109/L), more than 50% bone marrow plasma cells, neutrophil count not specific requirements; PLT =50 * 10^9/L, more than 50% of the patients with bone marrow plasma cells, platelets can be selected over 30 * 10^9/L; 6. liver and kidney function meet the following conditions: TBIL=2.0mg/dLALTAST=3.0×ULN, serum creatinine =3.0mg/dL or creatinine clearance rate =30ml/min; 7. Antithrombotic drugs such as low molecular heparin sodium or aspirin can be accepted; 8. ECOG 0~2, expected survival of more than 3 months; 9. The washout period from the last treatment (not including dexamethasone)is over two weeks (14 days); 10. has signed the informed consent form.;Inclusion criteria: 1. Patients was judged to Symptomatic multiple myeloma on the basis of guidelines for the diagnosis and treatment of multiple myeloma in China in 2015; 2. Eligible patients with RRMM were aged 18 years; 3. Patients had to be refractory to their previous treatment judged to have refractory or relapsed and refractory multiple myeloma; had to have received at least two previous consecutive cycles of bortezomib and lenalidomide, alone or in combination; 4. patients with measurable M protein, that is, at least one of the following 3 determinations: The serum M protein is more than 0.5g/dL (5g/L); The urine M protein is more than 200mg/24h; The determination of serum free light chain in serum free light chain ratio in exceptional circumstances, the involvement of free light chain levels greater than 10mg/dL (100 mg/L). 5. hematology meets the following conditions: ANC = 1 * 10^9/L (including under the support of G-CSF ANC = 1 * 109/L), more than 50% bone marrow plasma cells, neutrophil count not specific requirements; PLT =50 * 10^9/L, more than 50% of the patients with bone marrow plasma cells, platelets can be selected over 30 * 10^9/L; 6. liver and kidney function meet the following conditions: TBIL=2.0mg/dLALTAST=3.0×ULN, serum creatinine =3.0mg/dL or creatinine clearance rate =30ml/min; 7. Antithrombotic drugs such as low molecular heparin sodium or aspirin can be accepted; 8. ECOG 0~2, expected survival of more than 3 months; 9. The washout period from the last treatment (not including dexamethasone)is over two weeks (14 days); 10. has signed the informed consent form.;Inclusion criteria: 1. Patients was judged to Symptomatic multiple myeloma on the basis of guidelines for the diagnosis and treatment of multiple myeloma in China in 2015; 2. Eligible patients with RRMM were aged 18 years; 3. Patients had to be refractory to their previous treatment judged to have refractory or relapsed and refractory multiple myeloma; had to have received at least two previous consecutive cycles of bortezomib and lenalidomide, alone or in combination; 4. patients with measurable M protein, that is, at least one of the following 3 determinations: The serum M protein is more than 0.5g/dL (5g/L); The urine M protein is more than 200mg/24h; The determination of serum free light chain in serum free light chain ratio in exceptional circumstances, the involvement of free light chain levels greater than 10mg/dL (100 mg/L). 5. hematology meets the following conditions: ANC = 1 * 10^9/L (including under the support of G-CSF ANC = 1 * 109/L), more than 50% bone marrow plasma cells, neutrophil count not specific requirements; PLT =50 * 10^9/L, more than 50% of the patients with bone marrow plasma cells, platelets can be selected over 30 * 10^9/L; 6. liver and kidney function meet the following conditions: TBIL=2.0mg/dLALTAST=3.0×ULN, serum creatinine =3.0mg/dL or creatinine clearance rate =30ml/min; 7. Antithrombotic drugs such as low molecular heparin sodium or aspirin can be accepted; 8. ECOG 0~2, expected survival of more than 3 months; 9. The washout period from the last treatment (not including dexamethasone)is over two weeks (14 days); 10. has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. intolerate the treatment of thalidomide, Lenalidomide and Pomalidomide; 2. patients had an allergic reaction with a similar immune regulator, dexamethasone or the ingredients contained in the drug; 3. multiple myeloma with no secretion type; 4. patients with active new blood clots or disinclined to antithrombotic therapy; 5. patients with other tumors at the same time had previous or previous tumor history or had undergone anti-tumor therapy (including major surgery) in the last four weeks; Except for the following tumor diseases: skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, prostate cancer histological discovered accidentally (TNM clinical stage T1a or T1b) or have accepted treatment of prostate cancer; 6. patients with central nervous system disease or central nervous system history; 7. Patients were also considered ineligible if they had peripheral neuropathy of grade 3 or more; 8. patients who need long-term immunosuppressive or steroid drugs; 9. the hepatitis B virus (HBV -DNA is greater than 1*10^3 copies/ML) or hepatitis c virus (HCV) activity period, or human immunodeficiency virus (HIV) serological positive; 10. patients have any of the following items: substantial cardiac disease (New York Heart Association Class III or IV, congestive heart failure, myocardial infarction on or within 12 months or unstable or poorly controlled angina); 11. patients with severe infectious diseases at the same time; 12. patients who plan to become pregnant or fail to take reliable contraceptive measures; 13. pregnant women or lactating women; 14. received allogeneic hematopoietic stem cell transplantation patients, within 12 months or over 12 month in allogeneic hematopoietic stem cell transplantation has active graft versus host disease (GVHD) reaction or GVHD in patients receiving immunosuppressive therapy; 15. Participated in other clinical trials within one month.;Exclusion criteria: 1. intolerate the treatment of thalidomide, Lenalidomide and Pomalidomide; 2. patients had an allergic reaction with a similar immune regulator, dexamethasone or the ingredients contained in the drug; 3. multiple myeloma with no secretion type; 4. patients with active new blood clots or disinclined to antithrombotic therapy; 5. patients with other tumors at the same time had previous or previous tumor history or had undergone anti-tumor therapy (including major surgery) in the last four weeks; Except for the following tumor diseases: skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, prostate cancer histological discovered accidentally (TNM clinical stage T1a or T1b) or have accepted treatment of prostate cancer; 6. patients with central nervous system disease or central nervous system history; 7. Patients were also considered ineligible if they had peripheral neuropathy of grade 3 or more; 8. patients who need long-term immunosuppressive or steroid drugs; 9. the hepatitis B virus (HBV -DNA is greater than 1*10^3 copies/ML) or hepatitis c virus (HCV) activity period, or human immunodeficiency virus (HIV) serological positive; 10. patients have any of the following items: substantial cardiac disease (New York Heart Association Class III or IV, congestive heart failure, myocardial infarction on or within 12 months or unstable or poorly controlled angina); 11. patients with severe infectious diseases at the same time; 12. patients who plan to become pregnant or fail to take reliable contraceptive measures; 13. pregnant women or lactating women; 14. received allogeneic hematopoietic stem cell transplantation patients, within 12 months or over 12 month in allogeneic hematopoietic stem cell transplantation has active graft versus host disease (GVHD) reaction or GVHD in patients receiving immunosuppressive therapy; 15. Participated in other clinical trials within one month.;Exclusion criteria: 1. intolerate the treatment of thalidomide, Lenalidomide and Pomalidomide; 2. patients had an allergic reaction with a similar immune regulator, dexamethasone or the ingredients contained in the drug; 3. multiple myeloma with no secretion type; 4. patients with active new blood clots or disinclined to antithrombotic therapy; 5. patients with other tumors at the same time had previous or previous tumor history or had undergone anti-tumor therapy (including major surgery) in the last four weeks; Except for the following tumor diseases: skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, prostate cancer histological discovered accidentally (TNM clinical stage T1a or T1b) or have accepted treatment of prostate cancer; 6. patients with central nervous system disease or central nervous system history; 7. Patients were also considered ineligible if they had peripheral neuropathy of grade 3 or more; 8. patients who need long-term immunosuppressive or steroid drugs; 9. the hepatitis B virus (HBV -DNA is greater than 1*10^3 copies/ML) or hepatitis c virus (HCV) activity period, or human immunodeficiency virus (HIV) serological positive; 10. patients have any of the following items: substantial cardiac disease (New York Heart Association Class III or IV, congestive heart failure, myocardial infarction on or within 12 months or unstable or poorly controlled angina); 11. patients with severe infectious diseases at the same time; 12. patients who plan to become pregnant or fail to take reliable contraceptive measures; 13. pregnant women or lactating women; 14. received allogeneic hematopoietic stem cell transplantation patients, within 12 months or over 12 month in allogeneic hematopoietic stem cell transplantation has active graft versus host disease (GVHD) reaction or GVHD in patients receiving immunosuppressive therapy; 15. Participated in other clinical trials within one month.;Exclusion criteria: 1. intolerate the treatment of thalidomide, Lenalidomide and Pomalidomide; 2. patients had an allergic reaction with a similar immune regulator, dexamethasone or the ingredients contained in the drug; 3. multiple myeloma with no secretion type; 4. patients with active new blood clots or disinclined to antithrombotic therapy; 5. patients with other tumors at the same time had previous or previous tumor history or had undergone anti-tumor therapy (including major surgery) in the last four weeks; Except for the following tumor diseases: skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, prostate cancer histological discovered accidentally (TNM clinical stage T1a or T1b) or have accepted treatment of prostate cancer; 6. patients with central nervous system disease or central nervous system history; 7. Patients were also considered ineligible if they had peripheral neuropathy of grade 3 or more; 8. patients who need long-term immunosuppressive or steroid drugs; 9. the hepatitis B virus (HBV -DNA is greater than 1*10^3 copies/ML) or hepatitis c virus (HCV) activity period, or human immunodeficiency virus (HIV) serological positive; 10. patients have any of the following items: substantial cardiac disease (New York Heart Association Class III or IV, congestive heart failure, myocardial infarction on or within 12 months or unstable or poorly controlled angina); 11. patients with severe infectious diseases at the same time; 12. patients who plan to become pregnant or fail to take reliable contraceptive measures; 13. pregnant women or lactating women; 14. received allogeneic hematopoietic stem cell transplantation patients, within 12 months or over 12 month in allogeneic hematopoietic stem cell transplantation has active graft versus host disease (GVHD) reaction or GVHD in patients receiving immunosuppressive therapy; 15. Participated in other clinical trials within one month.;Exclusion criteria: 1. intolerate the treatment of thalidomide, Lenalidomide and Pomalidomide; 2. patients had an allergic reaction with a similar immune regulator, dexamethasone or the ingredients contained in the drug; 3. multiple myeloma with no secretion type; 4. patients with active new blood clots or disinclined to antithrombotic therapy; 5. patients with other tumors at the same time had previous or previous tumor history or had undergone anti-tumor therapy (including major surgery) in the last four weeks; Except for the following tumor diseases: skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, prostate cancer histological discovered accidentally (TNM clinical stage T1a or T1b) or have accepted treatment of prostate cancer; 6. patients with central nervous system disease or central nervous system history; 7. Patients were also considered ineligible if they had peripheral neuropathy of grade 3 or more; 8. patients who need long-term immunosuppressive or steroid drugs; 9. the hepatitis B virus (HBV -DNA is greater than 1*10^3 copies/ML) or hepatitis c virus (HCV) activity period, or human immunodeficiency virus (HIV) serological positive; 10. patients have any of the following items: substantial cardiac disease (New York Heart Association Class III or IV, congestive heart failure, myocardial infarction on or within 12 months or unstable or poorly controlled angina); 11. patients with severe infectious diseases at the same time; 12. patients who plan to become pregnant or fail to take reliable contraceptive measures; 13. pregnant women or lactating women; 14. received allogeneic hematopoietic stem cell transplantation patients, within 12 months or over 12 month in allogeneic hematopoietic stem cell transplantation has active graft versus host disease (GVHD) reaction or GVHD in patients receiving immunosuppressive therapy; 15. Participated in other clinical trials within one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of response;security index; | — |
Countries
China
Contacts
Public ContactJin Lu;Jin Lu;Jin Lu;Jin Lu;Jin Lu ;;;;
Peking University People's Hospital ;Peking University People's Hospital ;Peking University People's Hospital ;Peking University People's Hospital ;Peking University People's Hospital
Outcome results
None listed