A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Microtransplantation
- Sponsor
- Chen Wenming
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- progression-free survival
- Last Updated
- 9 years ago
Overview
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.
Investigators
Chen Wenming
professor
Beijing Chao Yang Hospital
Eligibility Criteria
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
- •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 -
Outcomes
Primary Outcomes
progression-free survival
Time Frame: 2 years
overall survival
Time Frame: 2 years
Secondary Outcomes
- rate of complete remission(2 year)
- minimal residual disease(2 year)
- hematopoietic recovery(3 month)
- infection(3 month)
- relapse(2 year)
- GVHD(1 year)