Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma

Phase 2

• Conditions: Multiple Myeloma
• Interventions: Radiation: Total marrow irradiation

• Registration Number: NCT01665014
• Lead Sponsor: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice

Brief Summary

The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and effective in patients with multiple myeloma (MM).

Detailed Description

AutoHSCT is a standard treatment of patients with MM. According to soem clinical evidence double autoHSCT provides survival advantage compared to a single procedure. Most frequently used conditioning regimen consists pf high doses of melphalan (HD-MEL). In some studies it was used in combination with total body irradiation (TBI), which, however was associated with significant toxicity. In our center the standard procedure includes TBI as a single treatment at 1st autoHSCT and HD-Mel at 2nd autoHSCT.

As in MM malignant plasma cells are localized almost exclusively in bone marrow there is rationale to limit irradiation to bones. For this purpose in the current study we substitute TBI with TMI. Additional boosts are provided for active sites of disease based on PET/CT imaging. Our intention is to minimize toxicity while maintaining the treatment efficacy.

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-11
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-17
• Primary Completion: 2015-12
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 18-65 years
• Diagnosis of multiple myeloma
• PR, VGPR or CR at inclusion
• Performance status WHO 0-1
• Written informed consent

Exclusion Criteria

• Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine >1.5 upper normal limit; LVEF <45%
• Active infection
• Unstable diabetes
• Psychiatric diseases
• History of high-dose chemotherapy or irradiation
• Second malignancy
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Total marrow irradiation	Total marrow irradiation	Double autologous hematopoietic stem cell transplantation using TMI and HD-Mel

Primary Outcome Measures

Name	Time	Method
Progression-free survival	three years

Secondary Outcome Measures

Name	Time	Method
Rate of complete and very good partial responses	six months

Trial Locations

Locations (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch; 🇵🇱 Gliwice, Poland