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Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
autologous hematopoietic stem cell transplantation, total marrow irradiation, melphalan, multiple myeloma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Total marrow irradiation
Type: Radiation
Overall Status
Not yet recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, Poland
Status: Not yet recruiting
Contact: Sebastian Giebel, MD - 0048322788523 - sgiebel@io.gliwice.pl
Start Date
August 2012
Completion Date
August 2016
Sponsors
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Source
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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