Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02981199

Enrollment

Registered

2016-12-05

Start date

2016-01-31

Completion date

2019-12-31

Last updated

2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autologous Stem Cell Transplantation, Microtransplantation, Multiple Myeloma in Relapse

Keywords

microtransplantation, multiple myeloma

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.

Interventions

PROCEDUREstem cell transplantation

conditioning with chemotherapy \[VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)\], then stem cell transfusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 -

Design outcomes

Primary

Measure	Time frame
progression-free survival	2 years
overall survival	2 years

Secondary

Measure	Time frame
hematopoietic recovery	3 month
infection	3 month
rate of complete remission	2 year
relapse	2 year
GVHD	1 year
minimal residual disease	2 year

Countries

China

Contacts

Primary ContactGuorong Wang, doctor

blunlake@163.com+861085231572

Backup ContactWenming Chen, doctor

wenming_chen@yahoo.com+8685231581

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026