Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

Multiple Myeloma in Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02981199
• Other study ID #: MM-MSCT-001
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2016
• Last updated: December 15, 2016
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: Beijing Chao Yang Hospital
• Contact: Guorong Wang, doctor
• Phone: +861085231572
• Email: blunlake[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autologous Stem Cell Transplantation
• Microtransplantation
• Multiple Myeloma
• Multiple Myeloma in Relapse
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chen Wenming	307 Hospital of PLA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		2 years	No
Primary	overall survival		2 years	No
Secondary	rate of complete remission		2 year	No
Secondary	minimal residual disease		2 year	No
Secondary	hematopoietic recovery		3 month	Yes
Secondary	infection		3 month	Yes
Secondary	GVHD		1 year	Yes
Secondary	relapse		2 year	No