BORTEZOMIB AND HIGH-DOSE MELPHALAN AS CONDITIONING REGIMEN BEFORE AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA: EXPERIENCE IN A UNIVERSITARY HOSPITAL.
(Abstract release date: 05/19/16)
EHA Library. De Miguel Llorente D. 06/09/16; 135075; PB2175
Dunia De Miguel Llorente
Contributions
Contributions
Abstract
Abstract: PB2175
Type: Publication Only
Background
The combination of bortezomib and high-dose melphalan (HDM) is an attractive approach to improve the efficacy of the conditioning regimen. Furthermore, this association was expected to be safe because bortezomib and melphalan do not share common toxicities (mainly neurologic toxicity for bortezomib and hematologic toxicity for HDM). We followed a phase 2 study of the Intergroupe Francophone du Myélome (IFM) (Blood 7 Jan 2010, 115 (1); 32-36)
Aims
1) to evaluate response rates after intensive therapy;2) to assess the toxicity of this new conditioning regimen.
Methods
We reported 29 Multiple Myeloma (MM) diagnosed patients [18 Males/11 Females, median age 59 years (34-73)]. Patients were treated between February 2010 and December 2015 to receive Bortezomib and melphalan as conditioning regimen (Bor-HDM). Bortezomib was administered subcutaneous at 1 mg/m2 on days −6, −3, 1, and 4. Melphalan was administered intravenously at 200 mg/m2 on day −2. All patients received induction treatment with VCD (Bortezomib 1,3 mg/m2 S.C. D1, D4, D8, D11; Cyclophosphamide 600 mg/m2 D1, D8; Dexamethasone 40 mg D1, D4, D8, D11) 6-8 cycles/21 days. Overall, 80% of patients achieved PR, including 8%VGPR and 12% patients with CR before ASCT. Peripheral blood stem cells [median 2.83 × 106 CD34+ cells/kg (1.97-4.39)] were infused on day 0.
Results
There was no engraftment failure. Neutrophils (ANC ≥ 0.5 × 109/L) and platelets (≥ 20 × 109/L without transfusion) recovered in median times of 11 days (range, 11-13 days) and 13 days (range, 11-18 days), respectively. Patients were discharged from the transplantation unit in median times of 27.5 days (range, 21-25 days). There were two treatment-related deaths, at +11 day of candidiasis (C. glabrata) and +15 day caused by Enterobacter sepsis.Some serious adverse events were reported:1) Infections (51% patients): bacteremia was documented: 4 Staphylococcus epidermidis, 1 Enterococcus faecalis, 1 Pseudomonas aeruginosa. 1 Salmonella diarrhea and 1 pneumonia.2) Mucositis:
Conclusion
Our experience shows that Bortezomib can safely be combined with HDM as a preparative regimen followed by ASCT. This regimen was well tolerated with no increased toxicity. Engraftment was not affected by the addition of Bortezomib. PN did not worse after this conditioning regimen.
Session topic: E-poster
Keyword(s): Autologous peripheral blood stem cell tansplantati, Bortezomib, Conditioning, Multiple myeloma
Type: Publication Only
Background
The combination of bortezomib and high-dose melphalan (HDM) is an attractive approach to improve the efficacy of the conditioning regimen. Furthermore, this association was expected to be safe because bortezomib and melphalan do not share common toxicities (mainly neurologic toxicity for bortezomib and hematologic toxicity for HDM). We followed a phase 2 study of the Intergroupe Francophone du Myélome (IFM) (Blood 7 Jan 2010, 115 (1); 32-36)
Aims
1) to evaluate response rates after intensive therapy;2) to assess the toxicity of this new conditioning regimen.
Methods
We reported 29 Multiple Myeloma (MM) diagnosed patients [18 Males/11 Females, median age 59 years (34-73)]. Patients were treated between February 2010 and December 2015 to receive Bortezomib and melphalan as conditioning regimen (Bor-HDM). Bortezomib was administered subcutaneous at 1 mg/m2 on days −6, −3, 1, and 4. Melphalan was administered intravenously at 200 mg/m2 on day −2. All patients received induction treatment with VCD (Bortezomib 1,3 mg/m2 S.C. D1, D4, D8, D11; Cyclophosphamide 600 mg/m2 D1, D8; Dexamethasone 40 mg D1, D4, D8, D11) 6-8 cycles/21 days. Overall, 80% of patients achieved PR, including 8%VGPR and 12% patients with CR before ASCT. Peripheral blood stem cells [median 2.83 × 106 CD34+ cells/kg (1.97-4.39)] were infused on day 0.
Results
There was no engraftment failure. Neutrophils (ANC ≥ 0.5 × 109/L) and platelets (≥ 20 × 109/L without transfusion) recovered in median times of 11 days (range, 11-13 days) and 13 days (range, 11-18 days), respectively. Patients were discharged from the transplantation unit in median times of 27.5 days (range, 21-25 days). There were two treatment-related deaths, at +11 day of candidiasis (C. glabrata) and +15 day caused by Enterobacter sepsis.Some serious adverse events were reported:1) Infections (51% patients): bacteremia was documented: 4 Staphylococcus epidermidis, 1 Enterococcus faecalis, 1 Pseudomonas aeruginosa. 1 Salmonella diarrhea and 1 pneumonia.2) Mucositis:
- · Grade 4 non-hematologic toxicities were mucositis of upper and lower digestive tract sites (10%).
- · The most frequently reported grade 1 or 2 adverse events were digestive (diarrhea, mucositis 55%).
Conclusion
Our experience shows that Bortezomib can safely be combined with HDM as a preparative regimen followed by ASCT. This regimen was well tolerated with no increased toxicity. Engraftment was not affected by the addition of Bortezomib. PN did not worse after this conditioning regimen.
Session topic: E-poster
Keyword(s): Autologous peripheral blood stem cell tansplantati, Bortezomib, Conditioning, Multiple myeloma
Abstract: PB2175
Type: Publication Only
Background
The combination of bortezomib and high-dose melphalan (HDM) is an attractive approach to improve the efficacy of the conditioning regimen. Furthermore, this association was expected to be safe because bortezomib and melphalan do not share common toxicities (mainly neurologic toxicity for bortezomib and hematologic toxicity for HDM). We followed a phase 2 study of the Intergroupe Francophone du Myélome (IFM) (Blood 7 Jan 2010, 115 (1); 32-36)
Aims
1) to evaluate response rates after intensive therapy;2) to assess the toxicity of this new conditioning regimen.
Methods
We reported 29 Multiple Myeloma (MM) diagnosed patients [18 Males/11 Females, median age 59 years (34-73)]. Patients were treated between February 2010 and December 2015 to receive Bortezomib and melphalan as conditioning regimen (Bor-HDM). Bortezomib was administered subcutaneous at 1 mg/m2 on days −6, −3, 1, and 4. Melphalan was administered intravenously at 200 mg/m2 on day −2. All patients received induction treatment with VCD (Bortezomib 1,3 mg/m2 S.C. D1, D4, D8, D11; Cyclophosphamide 600 mg/m2 D1, D8; Dexamethasone 40 mg D1, D4, D8, D11) 6-8 cycles/21 days. Overall, 80% of patients achieved PR, including 8%VGPR and 12% patients with CR before ASCT. Peripheral blood stem cells [median 2.83 × 106 CD34+ cells/kg (1.97-4.39)] were infused on day 0.
Results
There was no engraftment failure. Neutrophils (ANC ≥ 0.5 × 109/L) and platelets (≥ 20 × 109/L without transfusion) recovered in median times of 11 days (range, 11-13 days) and 13 days (range, 11-18 days), respectively. Patients were discharged from the transplantation unit in median times of 27.5 days (range, 21-25 days). There were two treatment-related deaths, at +11 day of candidiasis (C. glabrata) and +15 day caused by Enterobacter sepsis.Some serious adverse events were reported:1) Infections (51% patients): bacteremia was documented: 4 Staphylococcus epidermidis, 1 Enterococcus faecalis, 1 Pseudomonas aeruginosa. 1 Salmonella diarrhea and 1 pneumonia.2) Mucositis:
Conclusion
Our experience shows that Bortezomib can safely be combined with HDM as a preparative regimen followed by ASCT. This regimen was well tolerated with no increased toxicity. Engraftment was not affected by the addition of Bortezomib. PN did not worse after this conditioning regimen.
Session topic: E-poster
Keyword(s): Autologous peripheral blood stem cell tansplantati, Bortezomib, Conditioning, Multiple myeloma
Type: Publication Only
Background
The combination of bortezomib and high-dose melphalan (HDM) is an attractive approach to improve the efficacy of the conditioning regimen. Furthermore, this association was expected to be safe because bortezomib and melphalan do not share common toxicities (mainly neurologic toxicity for bortezomib and hematologic toxicity for HDM). We followed a phase 2 study of the Intergroupe Francophone du Myélome (IFM) (Blood 7 Jan 2010, 115 (1); 32-36)
Aims
1) to evaluate response rates after intensive therapy;2) to assess the toxicity of this new conditioning regimen.
Methods
We reported 29 Multiple Myeloma (MM) diagnosed patients [18 Males/11 Females, median age 59 years (34-73)]. Patients were treated between February 2010 and December 2015 to receive Bortezomib and melphalan as conditioning regimen (Bor-HDM). Bortezomib was administered subcutaneous at 1 mg/m2 on days −6, −3, 1, and 4. Melphalan was administered intravenously at 200 mg/m2 on day −2. All patients received induction treatment with VCD (Bortezomib 1,3 mg/m2 S.C. D1, D4, D8, D11; Cyclophosphamide 600 mg/m2 D1, D8; Dexamethasone 40 mg D1, D4, D8, D11) 6-8 cycles/21 days. Overall, 80% of patients achieved PR, including 8%VGPR and 12% patients with CR before ASCT. Peripheral blood stem cells [median 2.83 × 106 CD34+ cells/kg (1.97-4.39)] were infused on day 0.
Results
There was no engraftment failure. Neutrophils (ANC ≥ 0.5 × 109/L) and platelets (≥ 20 × 109/L without transfusion) recovered in median times of 11 days (range, 11-13 days) and 13 days (range, 11-18 days), respectively. Patients were discharged from the transplantation unit in median times of 27.5 days (range, 21-25 days). There were two treatment-related deaths, at +11 day of candidiasis (C. glabrata) and +15 day caused by Enterobacter sepsis.Some serious adverse events were reported:1) Infections (51% patients): bacteremia was documented: 4 Staphylococcus epidermidis, 1 Enterococcus faecalis, 1 Pseudomonas aeruginosa. 1 Salmonella diarrhea and 1 pneumonia.2) Mucositis:
- · Grade 4 non-hematologic toxicities were mucositis of upper and lower digestive tract sites (10%).
- · The most frequently reported grade 1 or 2 adverse events were digestive (diarrhea, mucositis 55%).
Conclusion
Our experience shows that Bortezomib can safely be combined with HDM as a preparative regimen followed by ASCT. This regimen was well tolerated with no increased toxicity. Engraftment was not affected by the addition of Bortezomib. PN did not worse after this conditioning regimen.
Session topic: E-poster
Keyword(s): Autologous peripheral blood stem cell tansplantati, Bortezomib, Conditioning, Multiple myeloma
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