‘Real-world’ Australian experience of pomalidomide for relapsed and refractory myeloma

Scott, Ashleigh; Weber, Nicholas; Taylor, Kerry; Taper, John; Harrison, Simon; Chan, Kah Lok; Stark, Richard; Lee, Cindy; Morris, Kirk; Ho, P. Joy; Dodds, Anthony J.; Ramanathan, Sundra; Ramakrishna, Raj; Watson, Anne-Marie; Auguston, Bradley; Kwok, Fiona; Quach, Hang; Warburton, Pauline; Rowlings, Philip; Mollee, Peter

doi:10.1080/10428194.2017.1387911

Cited by 11 publications

(15 citation statements)

References 13 publications

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“…In general, results of our study are comparable to other randomized clinical studies including ORR of 39.1% (compared with 31% in MM‐003 and 32.6% in MM‐010) and real‐world studies . We found statistically more effective is treatment with POM/DEX/BORT but we did not find any differences in PFS between POM/DEX/BORT vs POM/DEX.…”

Section: Discussionsupporting

confidence: 86%

“…7 In general, results of our study are comparable to other randomized clinical studies including ORR of 39.1% (compared with 31% in MM-003 and 32.6% in MM-010) and real-world studies. 6,7,[11][12][13] We found statistically more effective is treatment with POM/DEX/ BORT but we did not find any differences In conclusion, the real-world Polish cohort of RRMM patients has confirmed that pomalidomide is an active drug in this setting and has demonstrated similar response rates, and OS compared with the phase 3 MM-003, MM-010, and other real-world studies.…”

Section: Discussionmentioning

confidence: 48%

“…immunomodulatory drug, pomalidomide, real-world study, relapsed/refractory multiple myeloma High-risk FISH was defined as del(17/17p), t(4;14), t(14;16), t(14;20), gain(1q), del (13), or non-hyperdiploid karyotype in line with IMWG risk stratification in MM. 9…”

Section: Introductionmentioning

confidence: 99%

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The efficacy and safety of pomalidomide in relapsed/refractory multiple myeloma in a “real‐world” study: Polish Myeloma Group experience

Charliński

Grząśko

Jurczyszyn

et al. 2018

European J of Haematology

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 48%

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The efficacy and safety of pomalidomide in relapsed/refractory multiple myeloma in a “real‐world” study: Polish Myeloma Group experience

Charliński

Grząśko

Jurczyszyn

et al. 2018

European J of Haematology

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“…Interestingly, almost half of patients obtained a PFS which exceeded the PFS obtained with previous treatment, reverting the typical clinical course of MM characterized by decreased durability of response at each successive salvage regimen [19]. In all real-life experiences [16,18,19,34,35,36,37], there is a sub-group of patients in which continued exposure to poma resulted in stable disease that can be translated in survival prolongation. Most of these patients achieved only a minimal-partial response demonstrating the relevance of maintaining response rather than deepening response in a specific cohort of patients.…”

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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“…Furthermore, it is now apparent that carfilzomib can be given successfully in a weekly schedule . Similarly, pomalidomide has been shown to be effective in patients who are refractory to lenalidomide . A new regimen combining pomalidomide, carfilzomib and dexamethasone in relapsed and refractory patients has shown improved results in this cohort .…”

Section: Relapsed and Refractory Patientsmentioning

confidence: 95%

Biology and therapy of multiple myeloma

Joshua

Bryant

Dix

et al. 2019

Medical Journal of Australia

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Summary Genetic sequencing of the myeloma genome has not revealed a specific disease‐determining genetic alteration. Multiple disease subclones exist at diagnosis and vary in clinical importance with time and drug sensitivity. New diagnostic criteria have identified indications for early introduction of therapy. Autologous stem cell transplantation remains an essential component of therapy in young and fit patients. The use of continual suppressive (maintenance) therapy has been established as an important component in therapy. Immune therapies and the harnessing of the innate immune system offer great promise for future treatments. Since 2005, quality of life, supportive therapies, and survival have dramatically improved over a decade of remarkable progress. The common manifestations of multiple myeloma, such as bone pain, fatigue and weight loss, may be non‐specific and are often initially ignored or missed by patients and medical practitioners.

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‘Real-world’ Australian experience of pomalidomide for relapsed and refractory myeloma

Cited by 11 publications

References 13 publications

The efficacy and safety of pomalidomide in relapsed/refractory multiple myeloma in a “real‐world” study: Polish Myeloma Group experience

The efficacy and safety of pomalidomide in relapsed/refractory multiple myeloma in a “real‐world” study: Polish Myeloma Group experience

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

Biology and therapy of multiple myeloma

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