Multiple myeloma
Conditions
Interventions
CRD Cyclophosphamide 300 mg/m2 po (day1, 8, 15, 22) Lenalidomide 25 mg/body po (day1-21) Dexamethasone 40 mg/body po (day1, 8, 15, 22) CRD regimen is repeated every 4 weeks for 9 cycles Lenalid
Sponsors
The Jikei University School of Medicine
the Jikei University Daisan Hospital the Jikei University Kashiwa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. PS (ECOG) 0-2 2. Prior regimens >=1 3. Existence of measurable disease 4. The hemoglobin level >= 7.0mg/dl 5. The neutrophil counts >= 1,000/mm3 6. The platelet counts >= 50,000/mm3 7. T-bil <= 2.0 times of a facilities standard value 8. AST and ALT <= 3.0 times of a facilities standard value 9. CCr >= 30ml/min
Exclusion criteria
Exclusion criteria: 1. Non-secretory type multiple myeloma 2. Plasma cell leukemia 3. Ca >= 14mg/dl 4. Allergy to cyclophosphamide, lenalidomide, and dexamethasone 5. Plan for PBSCH 6. Active infection 7. Hemorrhagic diathesis, and coagulation disorder 8. Uncontrollable diabetes mellitus, hypertension, angina pectoris or congestive heart failure 9. HBV, HCV, and HIV infection 10. Impossibility to receive anti-coagulation agents 11. History of operation in 4 weeks 12. History of radiation therapy in 2 weeks 13. History of anti-cancer therapy, biological therapy, and immunological therapy 14. History of allogeneic transplant 15. Pregnancy 16. Doctor judged inadequate to enroll the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after CRD regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate after CRD regimen Overall response rate after lenalidomide maintenance therapy Complete response rate after lenalidomide maintenance therapy Progression free survival duration Overall survival duration incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactKazuhito Suzuki
The Jikei University School of Medicine Devision of Clinical Oncology/ Hematology
Outcome results
None listed