Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

Not Applicable

• Conditions: Multiple Myeloma in Relapse; Autologous Stem Cell Transplantation; Microtransplantation

• 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-11-30
• Status Verified: 2016-12
• Study First Posted: 2016-12-05
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
hematopoietic recovery	3 month
infection	3 month
relapse	2 year
GVHD	1 year

Trial Locations

Locations (1)

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China