BENDAMUSTINE, LENALIDOMIDE AND DEXAMETHASONE (BLD) COMBINATION THERAPY IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA: A SINGLE CENTER EXPERIENCE.
(Abstract release date: 05/19/16)
EHA Library. Ciuffreda L. 06/09/16; 134887; PB1987
Dr. Lucia Ciuffreda
Contributions
Contributions
Abstract
Abstract: PB1987
Type: Publication Only
Background
Lenalidomide is an analogue of thalidomide with immunomodulatory properties and is effective and safe in the treatment of Multiple Myeloma. Lenalidomide (Len) plus Dexamethasone (Dex) is approved for the treatment of Relapsed/Refractory MM patients following at least 1 prior therapy. Bendamustine (Ben), a bifuncyional agent, shares properties of alkilanting agents and purine analogs. We report data on efficacy and safety of BLD in patients (pts) with relapsed/refractory MM.
Aims
Our aim was to evaluate effectiveness and feasibility of BLD regimen in pts with relapsed or refractory MM
Methods
From September 2014 through October 2015 9 pts with relapsed or refractory MM with 1-3 prior lines of therapy were treated with BLD regimen. The series included 9 pts, six females and three males; 5 pts with relapsed MM and 4 with refractory MM. Median age was 70 (range 55-73). All patients had symptomatic MM and had previously been treated with bortezomib-based regimen. Five patients received BLD as second line therapy, four as third line.Ben was administered intravenously at a dose of 75 mg/mq on day one and two of each cycle. Pts received lenalidomide 10 mg orally on days 1- 21 and oral dexamethasone 40 mg/day (days 1, 8, 15 and 22). Cycles were repeated every 28 days for a total of 4 courses. Maintenance therapy included lenalidomide 25 mg/day on days 1-21 and dexamethasone 20 mg/die (days 1, 8, 15 and 22) until progression. Pts received concomitant anti-thrombotic (aspirin 100 mg/day) and anti-viral prophylaxis and additional supportive treatment with granulocyte colony stimulating factor (G-CSF) in case of grade 3 or grade 4 neutropenia occurring during cycles.Safety assessment (clinical exhamination, hematological evaluation) was performed weekly during cycle 1 and monthly thereafter. Response assessment was performed after four cycles. Response assessment was based on the International Uniform Response Criteria.
Results
As Grade 3-4 hematological toxicity we observed: neutropenia (55%), thrombocytopenia (44%) and anemia (33%). Grade 3-4 non hematologic adverse events were: infection (22%), hyperglycemia (33%), fatigue (44%) and diarrhea (11%). No thromboembolic events were reported. We did not observe peripheral neuropathies. One patient discontinued therapy because of prolonged neutropenia and thrombocytopenia. 8 patients were evaluated for response after four courses; 7 pts (87,5%) achieved al least a partial response (PR), including 3 (37,5%) very good partial response (VGPR) and 1 (12,5%) complete response (CR). 3 pts (after achieving VGPR) successfully harvested peripheral blood stem cells (PBSC).
Conclusion
In conclusion in our study BLD combination was well tolerated with a mild toxicity profile and has shown effectiveness in patients with relapsed or refractory MM. It could represent a reasonable option for relapsed-refractory MM pts, including transplant-eligible patients.
Session topic: E-poster
Keyword(s): Multiple myeloma
Type: Publication Only
Background
Lenalidomide is an analogue of thalidomide with immunomodulatory properties and is effective and safe in the treatment of Multiple Myeloma. Lenalidomide (Len) plus Dexamethasone (Dex) is approved for the treatment of Relapsed/Refractory MM patients following at least 1 prior therapy. Bendamustine (Ben), a bifuncyional agent, shares properties of alkilanting agents and purine analogs. We report data on efficacy and safety of BLD in patients (pts) with relapsed/refractory MM.
Aims
Our aim was to evaluate effectiveness and feasibility of BLD regimen in pts with relapsed or refractory MM
Methods
From September 2014 through October 2015 9 pts with relapsed or refractory MM with 1-3 prior lines of therapy were treated with BLD regimen. The series included 9 pts, six females and three males; 5 pts with relapsed MM and 4 with refractory MM. Median age was 70 (range 55-73). All patients had symptomatic MM and had previously been treated with bortezomib-based regimen. Five patients received BLD as second line therapy, four as third line.Ben was administered intravenously at a dose of 75 mg/mq on day one and two of each cycle. Pts received lenalidomide 10 mg orally on days 1- 21 and oral dexamethasone 40 mg/day (days 1, 8, 15 and 22). Cycles were repeated every 28 days for a total of 4 courses. Maintenance therapy included lenalidomide 25 mg/day on days 1-21 and dexamethasone 20 mg/die (days 1, 8, 15 and 22) until progression. Pts received concomitant anti-thrombotic (aspirin 100 mg/day) and anti-viral prophylaxis and additional supportive treatment with granulocyte colony stimulating factor (G-CSF) in case of grade 3 or grade 4 neutropenia occurring during cycles.Safety assessment (clinical exhamination, hematological evaluation) was performed weekly during cycle 1 and monthly thereafter. Response assessment was performed after four cycles. Response assessment was based on the International Uniform Response Criteria.
Results
As Grade 3-4 hematological toxicity we observed: neutropenia (55%), thrombocytopenia (44%) and anemia (33%). Grade 3-4 non hematologic adverse events were: infection (22%), hyperglycemia (33%), fatigue (44%) and diarrhea (11%). No thromboembolic events were reported. We did not observe peripheral neuropathies. One patient discontinued therapy because of prolonged neutropenia and thrombocytopenia. 8 patients were evaluated for response after four courses; 7 pts (87,5%) achieved al least a partial response (PR), including 3 (37,5%) very good partial response (VGPR) and 1 (12,5%) complete response (CR). 3 pts (after achieving VGPR) successfully harvested peripheral blood stem cells (PBSC).
Conclusion
In conclusion in our study BLD combination was well tolerated with a mild toxicity profile and has shown effectiveness in patients with relapsed or refractory MM. It could represent a reasonable option for relapsed-refractory MM pts, including transplant-eligible patients.
Session topic: E-poster
Keyword(s): Multiple myeloma
Abstract: PB1987
Type: Publication Only
Background
Lenalidomide is an analogue of thalidomide with immunomodulatory properties and is effective and safe in the treatment of Multiple Myeloma. Lenalidomide (Len) plus Dexamethasone (Dex) is approved for the treatment of Relapsed/Refractory MM patients following at least 1 prior therapy. Bendamustine (Ben), a bifuncyional agent, shares properties of alkilanting agents and purine analogs. We report data on efficacy and safety of BLD in patients (pts) with relapsed/refractory MM.
Aims
Our aim was to evaluate effectiveness and feasibility of BLD regimen in pts with relapsed or refractory MM
Methods
From September 2014 through October 2015 9 pts with relapsed or refractory MM with 1-3 prior lines of therapy were treated with BLD regimen. The series included 9 pts, six females and three males; 5 pts with relapsed MM and 4 with refractory MM. Median age was 70 (range 55-73). All patients had symptomatic MM and had previously been treated with bortezomib-based regimen. Five patients received BLD as second line therapy, four as third line.Ben was administered intravenously at a dose of 75 mg/mq on day one and two of each cycle. Pts received lenalidomide 10 mg orally on days 1- 21 and oral dexamethasone 40 mg/day (days 1, 8, 15 and 22). Cycles were repeated every 28 days for a total of 4 courses. Maintenance therapy included lenalidomide 25 mg/day on days 1-21 and dexamethasone 20 mg/die (days 1, 8, 15 and 22) until progression. Pts received concomitant anti-thrombotic (aspirin 100 mg/day) and anti-viral prophylaxis and additional supportive treatment with granulocyte colony stimulating factor (G-CSF) in case of grade 3 or grade 4 neutropenia occurring during cycles.Safety assessment (clinical exhamination, hematological evaluation) was performed weekly during cycle 1 and monthly thereafter. Response assessment was performed after four cycles. Response assessment was based on the International Uniform Response Criteria.
Results
As Grade 3-4 hematological toxicity we observed: neutropenia (55%), thrombocytopenia (44%) and anemia (33%). Grade 3-4 non hematologic adverse events were: infection (22%), hyperglycemia (33%), fatigue (44%) and diarrhea (11%). No thromboembolic events were reported. We did not observe peripheral neuropathies. One patient discontinued therapy because of prolonged neutropenia and thrombocytopenia. 8 patients were evaluated for response after four courses; 7 pts (87,5%) achieved al least a partial response (PR), including 3 (37,5%) very good partial response (VGPR) and 1 (12,5%) complete response (CR). 3 pts (after achieving VGPR) successfully harvested peripheral blood stem cells (PBSC).
Conclusion
In conclusion in our study BLD combination was well tolerated with a mild toxicity profile and has shown effectiveness in patients with relapsed or refractory MM. It could represent a reasonable option for relapsed-refractory MM pts, including transplant-eligible patients.
Session topic: E-poster
Keyword(s): Multiple myeloma
Type: Publication Only
Background
Lenalidomide is an analogue of thalidomide with immunomodulatory properties and is effective and safe in the treatment of Multiple Myeloma. Lenalidomide (Len) plus Dexamethasone (Dex) is approved for the treatment of Relapsed/Refractory MM patients following at least 1 prior therapy. Bendamustine (Ben), a bifuncyional agent, shares properties of alkilanting agents and purine analogs. We report data on efficacy and safety of BLD in patients (pts) with relapsed/refractory MM.
Aims
Our aim was to evaluate effectiveness and feasibility of BLD regimen in pts with relapsed or refractory MM
Methods
From September 2014 through October 2015 9 pts with relapsed or refractory MM with 1-3 prior lines of therapy were treated with BLD regimen. The series included 9 pts, six females and three males; 5 pts with relapsed MM and 4 with refractory MM. Median age was 70 (range 55-73). All patients had symptomatic MM and had previously been treated with bortezomib-based regimen. Five patients received BLD as second line therapy, four as third line.Ben was administered intravenously at a dose of 75 mg/mq on day one and two of each cycle. Pts received lenalidomide 10 mg orally on days 1- 21 and oral dexamethasone 40 mg/day (days 1, 8, 15 and 22). Cycles were repeated every 28 days for a total of 4 courses. Maintenance therapy included lenalidomide 25 mg/day on days 1-21 and dexamethasone 20 mg/die (days 1, 8, 15 and 22) until progression. Pts received concomitant anti-thrombotic (aspirin 100 mg/day) and anti-viral prophylaxis and additional supportive treatment with granulocyte colony stimulating factor (G-CSF) in case of grade 3 or grade 4 neutropenia occurring during cycles.Safety assessment (clinical exhamination, hematological evaluation) was performed weekly during cycle 1 and monthly thereafter. Response assessment was performed after four cycles. Response assessment was based on the International Uniform Response Criteria.
Results
As Grade 3-4 hematological toxicity we observed: neutropenia (55%), thrombocytopenia (44%) and anemia (33%). Grade 3-4 non hematologic adverse events were: infection (22%), hyperglycemia (33%), fatigue (44%) and diarrhea (11%). No thromboembolic events were reported. We did not observe peripheral neuropathies. One patient discontinued therapy because of prolonged neutropenia and thrombocytopenia. 8 patients were evaluated for response after four courses; 7 pts (87,5%) achieved al least a partial response (PR), including 3 (37,5%) very good partial response (VGPR) and 1 (12,5%) complete response (CR). 3 pts (after achieving VGPR) successfully harvested peripheral blood stem cells (PBSC).
Conclusion
In conclusion in our study BLD combination was well tolerated with a mild toxicity profile and has shown effectiveness in patients with relapsed or refractory MM. It could represent a reasonable option for relapsed-refractory MM pts, including transplant-eligible patients.
Session topic: E-poster
Keyword(s): Multiple myeloma
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