NCT04008888

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

Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

50 cases of HR-NDMM patients were divided into two groups nonrandomizedly. TE group received hematopoietic stem cell transplantation after induction therapy. Allo-sct for the young patients with suitable donors, Asct for the others. TNE group received consolidation therapy after induction therapy. All patients received PI-based maintenance therapy.

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

Type	Name	Description
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.

Timeline

• Start date: 2018-01-05
• Primary completion: 2020-01-01
• Completion: 2020-08-01
• First posted: 2019-07-05
• Last updated: 2019-07-05

Locations

1 site across 1 country: China