Contributions
Abstract: PB2212
Type: Publication Only
Background
Pomalidomide is currently utilized in relapsed/refractory multiple myeloma (RRMM) patients that have experienced bortezomib and lenalidomide treatment. In this setting the drug has shown in clinical trials improved survival and good tolerability.Since its approval in Italy, data on real life are still poor.
Aims
We conducted an analysis of RR MM patients treated with pomalidomide and dexamethasone (PomaD) in real life, previously enrolled in an interventional (STRATUS, MM-010) or currently enrolled in an observational study (MM-015) to provide further insights on this salvage therapy.
Methods
Between January 2016 and July 2017, 41 RR MM patients were treated with pomalidomide 4 mg daily po on days 1–21 of each 28-day cycle and dexamethasone 40 mg weekly (≤75 years) and 20 mg weekly (>75 years). Among patients 14 were enrolled in MM-015 study (an observational study) whereas additional 15 come from MM-010 study (a single-arm phase 3b study).
Results
We describe a total of 56 patients (median age 68 years, range 42-78). Median number of prior therapies was 4 (range 2-7). 29 (51%) patients had pre-existing severe anemia, 5 (9%) thrombocytopenia, 14 (25%) had renal impairment, 10 (18%) extramedullary myeloma;14 (25%) was high risk patients (r-ISS), 7 (12%) previously allo-transplanted. Median number of 8 (range 1-21) PomaD cycles were given. Overall treatment duration mean was 7.7 months. A half of the patients responded after at least one cycle. After a median follow-up of 12 months, median PFS and OS for patients were 6,7 and 9,9 months, respectively. At enrollment, 29 (51%) of patients were anemic, 15 (27%) neutropenic. The regimen was well tolerated with grade 3-4 haematological and non-haematological adverse events in 10 (18%) and 27 (48%) patients respectively. Grade 3-4 non-haematological AEs occurred in 48% of patients [most common: fatigue (7, 12,5%), pneumonia (6, 11%), diarrhea (3, 5%), glucose metabolism alteration (3, 5%), thromboembolism (2, 3,5%), diffuse erythema (2, 3,5%), hyponatremia (2, 3,5%), atrial flutter (1, 2%), acute renal failure (1, 2%)]. In case of serious AE, pomalidomide dose reduction (7, 12,5%) and discontinuation (11, 20%) were applied. All patients responded to treatment at the I/II cycle. Mostly PR and SD were observed. After a median time of 8 months (range 2-21) all patients relapsed. Data on 6-Months control of disease are favorable and related to Durie and Salmon stage. Almost 50% of patients obtained a control of disease with clinical benefit lasting 6 months. Moreover, patients with Stage I-IIA at PomaD-beginning had better probabilities of obtaining control of disease lasting almost 6 months. An unexpected data was the comparison between PFS obtained with the treatment before pomalidomide (previous treatment PFS, pPFS) and the PFS obtained with PomaD treatment (poPFS). 17 patients (30%) obtained a PFS longer than the precedent one. Among these patients, 6 were from STRATUS protocol and treatment was stopped at biochemical progression (25% increase in protein M) according to protocol indication. Difference between poPFS and pPFS was not statistically significant (log-rank p value 0.5).
Conclusion
Real life PomaD is well tolerated in RR MM patients prolonging PFS and OS with acceptable toxicity. Notably PFS could be superior to that obtained with precedent treatment and treatment may induce almost 6 months disease control in most patients intensively pre-treated.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, Refractory, Relapse, Immunomodulatory thalidomide analog
Abstract: PB2212
Type: Publication Only
Background
Pomalidomide is currently utilized in relapsed/refractory multiple myeloma (RRMM) patients that have experienced bortezomib and lenalidomide treatment. In this setting the drug has shown in clinical trials improved survival and good tolerability.Since its approval in Italy, data on real life are still poor.
Aims
We conducted an analysis of RR MM patients treated with pomalidomide and dexamethasone (PomaD) in real life, previously enrolled in an interventional (STRATUS, MM-010) or currently enrolled in an observational study (MM-015) to provide further insights on this salvage therapy.
Methods
Between January 2016 and July 2017, 41 RR MM patients were treated with pomalidomide 4 mg daily po on days 1–21 of each 28-day cycle and dexamethasone 40 mg weekly (≤75 years) and 20 mg weekly (>75 years). Among patients 14 were enrolled in MM-015 study (an observational study) whereas additional 15 come from MM-010 study (a single-arm phase 3b study).
Results
We describe a total of 56 patients (median age 68 years, range 42-78). Median number of prior therapies was 4 (range 2-7). 29 (51%) patients had pre-existing severe anemia, 5 (9%) thrombocytopenia, 14 (25%) had renal impairment, 10 (18%) extramedullary myeloma;14 (25%) was high risk patients (r-ISS), 7 (12%) previously allo-transplanted. Median number of 8 (range 1-21) PomaD cycles were given. Overall treatment duration mean was 7.7 months. A half of the patients responded after at least one cycle. After a median follow-up of 12 months, median PFS and OS for patients were 6,7 and 9,9 months, respectively. At enrollment, 29 (51%) of patients were anemic, 15 (27%) neutropenic. The regimen was well tolerated with grade 3-4 haematological and non-haematological adverse events in 10 (18%) and 27 (48%) patients respectively. Grade 3-4 non-haematological AEs occurred in 48% of patients [most common: fatigue (7, 12,5%), pneumonia (6, 11%), diarrhea (3, 5%), glucose metabolism alteration (3, 5%), thromboembolism (2, 3,5%), diffuse erythema (2, 3,5%), hyponatremia (2, 3,5%), atrial flutter (1, 2%), acute renal failure (1, 2%)]. In case of serious AE, pomalidomide dose reduction (7, 12,5%) and discontinuation (11, 20%) were applied. All patients responded to treatment at the I/II cycle. Mostly PR and SD were observed. After a median time of 8 months (range 2-21) all patients relapsed. Data on 6-Months control of disease are favorable and related to Durie and Salmon stage. Almost 50% of patients obtained a control of disease with clinical benefit lasting 6 months. Moreover, patients with Stage I-IIA at PomaD-beginning had better probabilities of obtaining control of disease lasting almost 6 months. An unexpected data was the comparison between PFS obtained with the treatment before pomalidomide (previous treatment PFS, pPFS) and the PFS obtained with PomaD treatment (poPFS). 17 patients (30%) obtained a PFS longer than the precedent one. Among these patients, 6 were from STRATUS protocol and treatment was stopped at biochemical progression (25% increase in protein M) according to protocol indication. Difference between poPFS and pPFS was not statistically significant (log-rank p value 0.5).
Conclusion
Real life PomaD is well tolerated in RR MM patients prolonging PFS and OS with acceptable toxicity. Notably PFS could be superior to that obtained with precedent treatment and treatment may induce almost 6 months disease control in most patients intensively pre-treated.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, Refractory, Relapse, Immunomodulatory thalidomide analog