Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

Conditions
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Microtransplantation, Autologous Stem Cell Transplantation, Multiple Myeloma in Relapse

Intervention / Treatment
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* Procedure: stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micro-SCT<br>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 | Procedure: stem cell transplantation<br>* conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion<br>|
| Active Comparator: Auto-SCT<br>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. | Procedure: stem cell transplantation<br>* conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2 years | 
| overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of complete remission |  | 2 year | 
| minimal residual disease |  | 2 year | 
| hematopoietic recovery |  | 3 month | 
| infection |  | 3 month | 
| GVHD |  | 1 year | 
| relapse |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microtransplantation, multiple myeloma