Contributions
Abstract: PB2181
Type: Publication Only
Background
Multiple myeloma (MM) is a complex and heterogeneous malignancy. Despite the widespread use of new agents and the use of less toxic and more efficient regimens, the treatment of relapsed and/or refractory MM (RRMM) is challenging, with poor outcome in most patients. Pomalidomide and low-dose Dexamethasone (Pd) is considered a standard of care in RRMM. To further improve its results, Pd has been associated with Cyclophosphamide (PCd)(Baz RC et al.2016; Chari A et al.2016) achieving an impressive 64.7% and 67% overall response rate (ORR) respectively. Many other combinations have been used (Ríos-Tamayo R et al.2017) without showing clear advantage over PCd. However, to our knowledge, the baseline addition of clarithromycin (c) to PCd (PCcd) has not been previously explored.
Aims
To assess in a preliminary way if the addition of c to PCd add clinical value to the triplet
Methods
Patients included in our MM population-based registry fulfilling RRMM status according with IMWG criteria, were prospectively treated with P 4 mg/day/21 days, C 50 mg/day/21 days, c 500mmg/12h/continous and d 40 mg/weekly, in cycles of 28 days. We estimated efficacy in terms of overall response rate (ORR), progression free survival (PFS) and overall survival (OS), as well as the main grade 3-4 toxicity.
Results
Since 2015, 24 RRMM patients have been treated with P-based regimens, and 19 of them received complete (not scaled) PCcd, 9 men and 10 women, median age at diagnosis 63 years (48-81). The ISS was I 47%, II 32% and III 21%. 5 patients (26.3%) had light chain MM.
PCcd was used as third line of therapy (LT) in 8 patients (42%), fourth LT in 3 (16%), fifth in 4 (21%) and subsequent LT in 3 (21%). Median of cycles administered was 5 (1-25). 12/17 patients achieved at least PR, with 70.5% ORR (11.8% CR). Median PFS and OS were 6.7 and 11 months, respectively. 4 patients have died (3 with progressive disease, 1 renal failure) whereas 11 remain ongoing in follow-up. No patient died due to infection. 5 patients (26.3%) are long-term responders, receiving 12 or more cycles. Neutropenia (grade 3-4) was documented in 57.9%. Infection (grade 3-4) was present in 26.3%. Thrombocytopenia (grade 3-4) was shown in 21.1%.
Conclusion
PCcd seems to be a convenient and optimized way to use P in real-life RRMM patients. This is an all-oral four-drug regimen with a remarkable ORR and a manageable safety profile. If PCcd is able to improve the outcome of PCd must be confirmed in a clinical trial.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, Relapse, Survival
Abstract: PB2181
Type: Publication Only
Background
Multiple myeloma (MM) is a complex and heterogeneous malignancy. Despite the widespread use of new agents and the use of less toxic and more efficient regimens, the treatment of relapsed and/or refractory MM (RRMM) is challenging, with poor outcome in most patients. Pomalidomide and low-dose Dexamethasone (Pd) is considered a standard of care in RRMM. To further improve its results, Pd has been associated with Cyclophosphamide (PCd)(Baz RC et al.2016; Chari A et al.2016) achieving an impressive 64.7% and 67% overall response rate (ORR) respectively. Many other combinations have been used (Ríos-Tamayo R et al.2017) without showing clear advantage over PCd. However, to our knowledge, the baseline addition of clarithromycin (c) to PCd (PCcd) has not been previously explored.
Aims
To assess in a preliminary way if the addition of c to PCd add clinical value to the triplet
Methods
Patients included in our MM population-based registry fulfilling RRMM status according with IMWG criteria, were prospectively treated with P 4 mg/day/21 days, C 50 mg/day/21 days, c 500mmg/12h/continous and d 40 mg/weekly, in cycles of 28 days. We estimated efficacy in terms of overall response rate (ORR), progression free survival (PFS) and overall survival (OS), as well as the main grade 3-4 toxicity.
Results
Since 2015, 24 RRMM patients have been treated with P-based regimens, and 19 of them received complete (not scaled) PCcd, 9 men and 10 women, median age at diagnosis 63 years (48-81). The ISS was I 47%, II 32% and III 21%. 5 patients (26.3%) had light chain MM.
PCcd was used as third line of therapy (LT) in 8 patients (42%), fourth LT in 3 (16%), fifth in 4 (21%) and subsequent LT in 3 (21%). Median of cycles administered was 5 (1-25). 12/17 patients achieved at least PR, with 70.5% ORR (11.8% CR). Median PFS and OS were 6.7 and 11 months, respectively. 4 patients have died (3 with progressive disease, 1 renal failure) whereas 11 remain ongoing in follow-up. No patient died due to infection. 5 patients (26.3%) are long-term responders, receiving 12 or more cycles. Neutropenia (grade 3-4) was documented in 57.9%. Infection (grade 3-4) was present in 26.3%. Thrombocytopenia (grade 3-4) was shown in 21.1%.
Conclusion
PCcd seems to be a convenient and optimized way to use P in real-life RRMM patients. This is an all-oral four-drug regimen with a remarkable ORR and a manageable safety profile. If PCcd is able to improve the outcome of PCd must be confirmed in a clinical trial.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Multiple Myeloma, Relapse, Survival