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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total marrow irradiation | Experimental | Double autologous hematopoietic stem cell transplantation using TMI and HD-Mel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total marrow irradiation | Radiation | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | three years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete and very good partial responses | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of severe adverse events | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Giebel, MD | Contact | 0048322788523 | sgiebel@io.gliwice.pl |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Giebel, MD | Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch | Gliwice | 44-101 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21047977 | Background | Somlo G, Spielberger R, Frankel P, Karanes C, Krishnan A, Parker P, Popplewell L, Sahebi F, Kogut N, Snyder D, Liu A, Schultheiss T, Forman S, Wong JY. Total marrow irradiation: a new ablative regimen as part of tandem autologous stem cell transplantation for patients with multiple myeloma. Clin Cancer Res. 2011 Jan 1;17(1):174-82. doi: 10.1158/1078-0432.CCR-10-1912. Epub 2010 Nov 3. |
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|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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