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Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
Primary Efficacy and safety of the procedure in terms of number of remissions, survival, event-free survival, relapse risk, and early transplant-related mortality (up to day +100).
Secondary Graft kinetics (time to neutrophil and platelet recovery after ASCT) 2.Analyze the presence of transplant-related complications (infections, sinusoidal occlusive syndrome and others) 3.Analyze prognostic factors for engraftment, remission rate, relapse risk, disease-free and overall survival after ASCT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous busulfan and melphalan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous busulfan and melphalan | Drug | BU is administered intravenously at a dose of 3.2 mg/kg over three hours once a day on days -5 to -3 (total dose 9.6 mg/kg), followed by MEL at a dose of 140 mg/m2 on day -2. After one day of rest, progenitor cells are infused on day 0. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen. | Within the first three months after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival | Up to 5 years after transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier de la Rubia, MD | Contact | 34963862746 | delarubia_jav@gva.es | |
| Guillermo Sanz, MD | Contact | 34963862746 | sanz_gui@gva.es |
| Name | Affiliation | Role |
|---|---|---|
| Miguel A Sanz, MD | S: de Hematología. Hospital La Fe, Valencia. Spain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Insular Canarias | Recruiting | Las Palmas de Gran Canaria | Las Palmas | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22897964 | Derived | Blanes M, Lahuerta JJ, Gonzalez JD, Ribas P, Solano C, Alegre A, Blade J, San Miguel JF, Sanz MA, de la Rubia J. Intravenous busulfan and melphalan as a conditioning regimen for autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: a matched comparison to a melphalan-only approach. Biol Blood Marrow Transplant. 2013 Jan;19(1):69-74. doi: 10.1016/j.bbmt.2012.08.009. Epub 2012 Aug 13. |
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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 |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| H La Princesa | Recruiting | Madrid | Madrid | Spain |
|
| H. 12 de Octubre | Recruiting | Madrid | Madrid | Spain |
|
| S. de Hematología. Hospital La Fe | Recruiting | Valencia | Valencia | 46009 | Spain |
|
| Hospital Clínico | Recruiting | Valencia | Valencia | Spain |
|
| Hospital Dr. Peset | Recruiting | Valencia | Valencia | Spain |
|
| 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 |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |