Multiple Myeloma
Conditions
Keywords
autologous hematopoietic stem cell transplantation, total marrow irradiation, melphalan, multiple myeloma
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.
Interventions
RADIATIONTotal marrow irradiation
Mobilization of stem cells with the use of cytarabine 1.6 g/m2 followed by filgrastim 480 ug/d. Conditioning for the 1st autoHSCT: total marrow irradiation 4 Gy on days -3,-2,-1 (total 12 Gy). Conditioning for 2nd autoHSCT performed 3-4 months after the 1st one: melphalan 100 mg/m2 on days -2,-3 (total 200 mg/m2)
Sponsors
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | three years |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete and very good partial responses | six months |
Other
| Measure | Time frame |
|---|---|
| Rate of severe adverse events | one year |
Countries
Poland
Contacts
Primary ContactSebastian Giebel, MD
Outcome results
None listed