Clinical trial NCT02981199: Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Official title: A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microtransplantation
Autologous Stem Cell Transplantation
Multiple Myeloma in Relapse
Keywords: microtransplantation
multiple myeloma
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: 307 Hospital of PLA
First posted: 2016-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
Secondary outcomes:
measure: rate of complete remission
timeFrame: 2 year
measure: minimal residual disease
timeFrame: 2 year
measure: hematopoietic recovery
timeFrame: 3 month
measure: infection
timeFrame: 3 month
measure: GVHD
timeFrame: 1 year
measure: relapse
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Wenming Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: