Real world Italian experience of pomalidomide plus low-dose dexamethasone in the relapsed and refractory myeloma setting: extended follow-up of a retrospective multicenter study by the ‘Rete Ematologica Pugliese E Basilicata’

Mele, Giuseppe; Pastore, Domenico; Renzo, Nicola Di; Fragasso, Alberto; Guarini, Attilio; Mazza, Patrizio; Musto, Pellegrino; Pavone, Vincenzo; Tarantini, Giuseppe; Curci, Paola; Falcone, Antonietta; Mele, Anna; Miccolis, Maria Rosanna; Palazzo, Giulia; Palumbo, Gaetano; Quinto, Angela Maria; Reddiconto, Giovanni; Rizzi, Rita; Cascavilla, Nicola; Specchia, Giorgina; Capalbo, Silvana

doi:10.1080/10428194.2019.1636989

Cited by 9 publications

(11 citation statements)

References 14 publications

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“…The median DoR in POWERFUL (15.8 months) was within the range of that reported in the clinical trial setting (8.3-16.6 months) [7,15], while the TTR was somewhat longer (3.2 vs. 1.9 months) [15]. Other real-world studies performed in Poland, Italy, and the United Kingdom have reported higher ORR (39.1-52.9%) than in POWERFUL, but it should be noted that the response rates in all these studies were derived in the response-evaluable population, and, therefore, they should be compared to the 42.1% rate observed in the present study [22][23][24]. The PFS benefit in POWERFUL is also comparable to the 12.2-month PFS and the 50.2% 1-year PFS rate reported in the study of Siegel et al in which all patients had received LEN in the last treatment line [7], but it was more pronounced than that observed in other studies, where the median PFS ranged between 4.0 and 6.5 months [16,17,25].…”

Section: Discussioncontrasting

confidence: 47%

Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study

Terpos

Repousis

Lalayanni

et al. 2021

JCM

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The “POWERFUL” multicenter, retrospective, and prospective study investigated the effectiveness of pomalidomide plus low-dose dexamethasone (POM/LoDex) therapy in relapsed/refractory multiple myeloma in routine care in Greece. Ninety-nine eligible adult patients treated with POM/LoDex according to the approved label after having received ≥2 prior therapies, including lenalidomide and bortezomib, were consecutively enrolled between 16 November 2017 and 21 February 2019 in 18 hematology departments. Fifty patients (50.5%) started POM/LoDex as third-line treatment. During the treatment period (median: 8.3 months; range: 0.3–47.6 months), the median POM dose was 4 mg/day, and 31.3% of the patients received additional antimyeloma agents. The overall response rate was 32.3%. During a median follow-up period of 13.8 months (Kaplan–Meier estimate), the median progression-free survival (PFS) was 10.5 months (95% CI: 7.4–14.4). The PFS was not significantly different between patients receiving POM/LoDex in the third versus later line of therapy, nor between patients receiving concomitant antimyeloma therapy versus POM/LoDEx doublet. During the prospective safety data collection period (median: 7.6 months) among patients with prospective follow-up (N = 75), POM-related adverse event incidence rate was 42.7% (serious: 18.7%; grade ≥ 3 hematological POM-related adverse events: 8.0%). Only neutropenia (13.3%) was reported at a frequency ≥10%. In conclusion, in this real-world study, POM/LoDex displayed a long PFS with no new safety signals emerging.

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Section: Discussioncontrasting

confidence: 47%

Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study

Terpos

Repousis

Lalayanni

et al. 2021

JCM

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“…Age > 70 years, haematological response, and previous therapies did not influence OS although the frailty score and high serum LDH did [27]. Another large study includes 87 evaluable patients (69% double refractory) [22], treated with PomaD in Australia between 2010 and 2015. After a median follow-up of six months, the overall response rate was 32% with a median PFS of 3.4 months and a median OS of 7.5 months [22].…”

Section: Discussionmentioning

confidence: 99%

“…Another large study includes 87 evaluable patients (69% double refractory) [22], treated with PomaD in Australia between 2010 and 2015. After a median follow-up of six months, the overall response rate was 32% with a median PFS of 3.4 months and a median OS of 7.5 months [22]. Age < 65 years, male sex, hemoglobin <100 g/L, and platelets < 100 × 10 9 /L values had statistical significance for PFS whereas age < 65 years, double refractory status, hemoglobin < 100 g/L, and platelets < 100 × 10 9 /L were significant for OS.…”

Section: Discussionmentioning

confidence: 99%

Clinical Benefit of Long-Term Disease Control with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

Parisi

Leotta

Romano

et al. 2019

JCM

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Background: We retrospectively analysed relapsed/refractory MM (RRMM) patients treated with pomalidomide and dexamethasone (PomaD) either in real life, or previously enrolled in an interventional (STRATUS, MM-010) or currently enrolled in an observational study (MM-015) to provide further insights on safety and tolerability and clinical efficacy. Methods: Between July 2013 and July 2018, 76 RRMM patients (including 33 double refractory MM) received pomalidomide 4 mg daily given orally on days 1–21 of each 28-day cycle, and dexamethasone 40 mg weekly (≤75 years) or 20 mg weekly for patients aged > 75 years. In nine patients a third agent was added to increase the response: Cyclophosphamide (in two fit patients) or clarithromycin (in seven frail patients). Patients received subcutaneous filgrastim as part of the prophylaxis regimen for neutropenia. Results: A median number of six (range 2–21) PomaD cycles were given. The regimen was well tolerated with grade 3–4 haematological and non-haematological adverse events in 39 (51%) and 25 (33%) patients, respectively. In patients who developed serious AE, pomalidomide dose reduction (11%, 14%) or definitive discontinuation (18%, 23%) were applied. All patients have been evaluated for response within the first two cycles. The disease control rate (DCR), i.e., those patients that had a response equal or better than stable disease (≥ SD), was high (89%), with 44% overall response rate (ORR) after six cycles. The achieved best responses were complete remission (CR, 5%), very good partial remission (VGPR, 4%), partial remission (PR, 35%), minimal response (MR, 7%), and stable disease (SD, 38%). After a median follow up of 19.6 months, median progression free survival was 9.4 months, and overall survival (OS) was 19.02 months. Univariate analysis showed that double refractory patients, or who received more than three previous lines had shorter PFS. At 18 months, regardless of the depth of response, patients with a disease control of at least six months, defined as maintenance of a best clinical and/or biochemical response to treatment for almost six months, had prolonged PFS (35.3% versus 20.6%, p = 0.0003) and OS (81.2% versus 15.9%, p < 0.0001) Conclusions: Our findings indicate that PomaD is a safe and well-tolerated regimen in real-life, associated with prolonged PFS and OS with acceptable toxicity. Moreover, Pd induced disease control in most intensively pre-treated patients and some of them achieved longer PFS than that obtained with the previous treatment.

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“…To the best of our knowledge, this is the first prospective study investigating the effectiveness of POM/DEX in a real‐world setting. However, several retrospective, mostly smaller studies from different countries, in which patients with R/RMM or patients with relapsed and refractory MM who had been treated with POM with or without DEX were analyzed, have been published during the last years 21–27 . With respect to the results on PFS, the POSEIDON study compares favorably with reported median PFS of 5.2 months each from two smaller studies from the UK 21,22 and the median PFS of 3.5 months reported from an Australian study 23 .…”

Section: Discussionmentioning

confidence: 91%

“…In two smaller studies from Poland 24 and Italy, 27 longer median PFS of 10.0 months and 9.4 months, respectively, were demonstrated. With respect to treatment response, either similar 23,25 or markedly higher response rates ranging from ORRs of 41%–53% have been reported 21,22,24,26,27 . Except for the study of Mele et al, 26 patients were younger in all the referenced studies with median age ranging from 59 to 66 years.…”

Section: Discussionmentioning

confidence: 91%

Pomalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma: Final results of the non‐interventional study POSEIDON and comparison with the pivotal phase 3 clinical trials

Dechow

Aldaoud

Behlendorf

et al. 2021

European J of Haematology

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Background Prognosis of patients with multiple myeloma (MM) who have relapsed on or become refractory to immunomodulators and bortezomib is poor, and treatment options are limited. While pomalidomide plus low‐dose dexamethasone (POM/DEX) has demonstrated efficacy in clinical trials, real‐world evidence is scarce. Patients and Methods POSEIDON was a prospective non‐interventional study designed to evaluate effectiveness, safety and quality of life (QoL) of POM/DEX in patients with relapsed or refractory MM (R/RMM) pretreated with at least two prior therapy lines including both lenalidomide and bortezomib in real world in Germany. Patients received POM/DEX according to physicians’ choice. Data were analyzed descriptively. Results Between 2014 and 2017, 151 patients were enrolled, 144 patients with a median of three prior therapy lines qualified for effectiveness analysis. Median age was 73.2 years. Median progression‐free and overall survival were 6.3 months [95% confidence interval (CI) 5.2, 8.6] and 12.9 months [95% CI 10.6, 15.1]. Most frequent grade 3/4 adverse events were leukopenia (8.2%), pneumonia (7.5%) and anemia (5.5%). QoL was maintained after start of POM/DEX. Conclusion The results of POSEIDON support the effectiveness and safety of POM/DEX in R/RMM patients pretreated with lenalidomide and bortezomib and highlight the clinical value of the POM/DEX regimen in the real‐world setting. Registered at clinicaltrials.gov (NCT02075996).

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Real world Italian experience of pomalidomide plus low-dose dexamethasone in the relapsed and refractory myeloma setting: extended follow-up of a retrospective multicenter study by the ‘Rete Ematologica Pugliese E Basilicata’

Cited by 9 publications

References 14 publications

Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study

Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World “POWERFUL” Study

Clinical Benefit of Long-Term Disease Control with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

Pomalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma: Final results of the non‐interventional study POSEIDON and comparison with the pivotal phase 3 clinical trials

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