Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
- Conditions
- Multiple Myeloma in RelapseAutologous Stem Cell TransplantationMicrotransplantation
- Interventions
- Procedure: stem cell transplantation
- Registration Number
- NCT02981199
- Lead Sponsor
- Chen Wenming
- Brief Summary
Comparison of the efficacy and safety of microtransplantation and autologous transplantation in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed. To identify the role of microtransplantation in the treatment of multiple myeloma.
- Detailed Description
NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT, were randomly divided into two arms. One arm receive microtransplantation, and the other accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were also been observed. Clear the above program related hematopoietic recovery, remission rate, infection and recurrence rate, survival rate and the formation of micro inlay, minimal residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment of multiple myeloma.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Diagnosis MM compliance with IMWG diagnostic criteria(2014)
- induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR
- KPS ≥60，ECOG≤2 4）Age 18-65，eligible for SCT 5）Heart function < II level (NYHA standard) and ejection fraction > 50% -
- KPS<60
- Allergy to bortezomib,epirubicin, or drug ingredients
- Severe hepatitis and organ dysfunction: a serious infection has not been controlled; cardiac ejection fraction <50%, serum bilirubin >3mg/dl, severe abnormal results of liver function test (AST is greater than 3 times the upper limit), severe renal injury; central nervous system disorders, uncontrolled mental illness
- With more than 2 bortezomib associated with peripheral neuropathy or neuralgia patients
- Patients with active stage of the herpes zoster
- Women in pregnancy or lactation
- MM with AL or EM plasma cell tumor
- The patient refused to accept the above treatment and signature
- Donor does not meet the requirements: including HIV positive, active hepatitis B, bone marrow disease, donor refused to provide hematopoietic stem cells and do not agree to sign.
- Epirubicin / other anthracyclines previously accumulated more than 240mg/m2 -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Micro-SCT stem cell transplantation patients treated with microtransplantation. \[VMD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; melphalan 60mg/m2 d1; dexamethasone 20mg d1,2,4,5,8,9,11,12) + low dose allogeneic stem cell transplantation\]×4cycles; \[PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)\]×1cycle; then maintenance therapy with thalidomide 100mg/d. microtransplantation = \[VMD regimen chemotherapy+ low dose allogeneic stem cell transplantation\]×4cycles Auto-SCT stem cell transplantation patients treated with Auto-SCT. conditioning with Mel+Vel regimen (melphalan 200mg/m2 d-2, bortezomib 1.3mg/m2 d-6,-3,+1,+4) + autogeneic stem cell transplantation; \[PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)\]×4cycle; then maintenance therapy with thalidomide 100mg/d.
- Primary Outcome Measures
Name Time Method progression-free survival 2 years overall survival 2 years
- Secondary Outcome Measures
Name Time Method rate of complete remission 2 year minimal residual disease 2 year infection 3 month relapse 2 year GVHD 1 year hematopoietic recovery 3 month
Trial Locations
- Locations (1)
Beijing Chaoyang Hospital
🇨🇳Beijing, Beijing, China