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Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

C

Chen Wenming

Status

Unknown

Conditions

Multiple Myeloma in Relapse
Autologous Stem Cell Transplantation
Microtransplantation

Treatments

Procedure: stem cell transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02981199
MM-MSCT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Diagnosis MM compliance with IMWG diagnostic criteria(2014)
  2. induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR
  3. KPS ≥60,ECOG≤2 4)Age 18-65,eligible for SCT 5)Heart function < II level (NYHA standard) and ejection fraction > 50% -

Exclusion criteria

  1. KPS<60
  2. Allergy to bortezomib,epirubicin, or drug ingredients
  3. 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
  4. With more than 2 bortezomib associated with peripheral neuropathy or neuralgia patients
  5. Patients with active stage of the herpes zoster
  6. Women in pregnancy or lactation
  7. MM with AL or EM plasma cell tumor
  8. The patient refused to accept the above treatment and signature
  9. 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.
  10. Epirubicin / other anthracyclines previously accumulated more than 240mg/m2 -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Micro-SCT
Active Comparator group
Description:
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
Treatment:
Procedure: stem cell transplantation
Auto-SCT
Active Comparator group
Description:
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.
Treatment:
Procedure: stem cell transplantation

Trial contacts and locations

1

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Central trial contact

Wenming Chen, doctor; Guorong Wang, doctor

Data sourced from clinicaltrials.gov

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