a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients

Summary

The clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. The objective was to assess the progression free survival (PFS), overall survival (OS),and overall response rate (ORR) of the overall treatment.

Conditions

• Multiple Myeloma
• Plasma Cell Leukemia
• Extramedullary Plasmacytoma
• Loss of Chromosome 17p
• t(14;16)
• t(4;14)
• T(14;20)
• 1Q21 Amplification
• Complex Karyotype

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic Stem Cell Transplant: Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients.

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2

Autologous hematopoietic stem cell transplantation :Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day followed collecting CD34+ peripheral blood stem cells . Day 0 Infusion of autologous stem cells. Patients during 3-6 months after the 1st SCT will undergo a 2nd SCT. Patients who had not enough PBSC will undergo a 1st SCT.

DRUG

Melphalan Given IV

conditioning regimen: autologous ARM: Day -2 Melphalan 200 mg/m\^2/day IV over 30 minutes. allogeneic ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes

DRUG

Fludarabine Injection

conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV

DRUG

PI and dexamethasone as maintenance therapy

Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)

DRUG

PI+IMids+Dexamethasone as Consolidated Chemotherapy

Oral lenalidomide at the starting dose of 25mg on days 1-21 every 28 days or days 1-14 every 21 days. Dexamethasone at 20mg twice weekly on days 1,2,4,5,8,9,11\&12 of each 21-day.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Principal Investigators

• Lu G Qiu, Dr. · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-05

Primary Completion

2020-01-01

Completion

2020-08-01

Countries

• China

Study Locations