ORIGINAL ARTICLEPhase 2 Study of Pegylated Liposomal Doxorubicin, Vincristine, Decreased-Frequency Dexamethasone, and Thalidomide in Newly Diagnosed and Relapsed-Refractory Multiple Myeloma
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PATIENTS AND METHODS
Eligibility criteria included age older than 18 years, active multiple myeloma with a measurable serum or urine paraprotein level, and ability to understand and sign an informed consent document. Active multiple myeloma was defined by evidence of end-organ damage related to the plasma cell disease.18 Patients had to have an Eastern Cooperative Oncology Group performance status of 0 to 2, a serum bilirubin level less than 2 times the upper limit of normal, serum alanine aminotransferase and
Patient Characteristics
One hundred five patients were enrolled in the trial. Three patients did not complete at least one cycle and were not evaluable for response but were evaluable for toxic effects. The 102 patients who completed at least one cycle included 53 with newly diagnosed disease and 49 with relapsed-refractory disease. The median age for all patients was 63 years (IQR, 53-69 years), 56% were male, and 79% were white. The SWOG staging for all patients was as follows: 25%, 46%, 4%, and 25% had stages I,
DISCUSSION
Despite the addition of various chemotherapeutic agents and the trials of high-dose therapy with supportive autologous stem cell transplantation, multiple myeloma continues to be an incurable disease.27 The DVd regimen, with a better tolerability and ease of administration, does not result in high-quality responses or survival advantages when compared with traditional regimens.7, 8 In this study, we show that the addition of thalidomide to the DVd regimen not only improves the response rate but
CONCLUSIONS
Adding thalidomide to the DVd regimen improved the response rate and the quality of response in patients with multiple myeloma comparable to what is achieved with high-dose therapy. The improved quality of response (CR plus VGPR) was associated with improved outcome as measured by PFS and OS. The high rate of CR plus VGPR makes this regimen an attractive induction chemotherapy regimen for patients with newly diagnosed multiple myeloma before proceeding with high-dose therapy and stem cell
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Real-world Outcomes of Multiple Myeloma: Retrospective Analysis of the Czech Registry of Monoclonal Gammopathies
2018, Clinical Lymphoma, Myeloma and LeukemiaCitation Excerpt :Exploratory subgroup analyses revealed that age, ISS stage at diagnosis, IMWG risk category at diagnosis, SCT status, and treatment response all had a significant effect on OS and PFS, especially in early treatment lines. The associations between these variables and outcomes were generally as expected, and the absolute values for OS and PFS were consistent with observations from clinical trials.15-18 The overall median OS in the present study (50.3 months) was longer than that observed in the Dutch Population-based Haematological Registry for Observational Studies (PHAROS) analysis (37.5 months).19
How have evolutions in strategies for the treatment of relapsed/refractory multiple myeloma translated into improved outcomes for patients?
2017, Critical Reviews in Oncology/HematologyCitation Excerpt :In phase 2 studies of single‐agent thalidomide, up to 9% of participants experienced PN and approximately 2% had deep vein thrombosis (DVT) (Barlogie et al., 2001). Thalidomide in combination with chemotherapy and dexamethasone was also found to be associated with neurotoxicity, and the risk of DVT was higher than with thalidomide monotherapy (Hussein et al., 2006). In the phase 3, single-agent OPTIMUM trial, 37% of patients receiving thalidomide had clinical evidence of neuropathy (Kropff et al., 2012).
Relapsed and Refractory Multiple Myeloma: New Therapeutic Strategies
2014, Hematology/Oncology Clinics of North AmericaManagement Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives
2012, Seminars in Hematology
This study was supported in part by a research grant from Celgene Corporation, Ortho Biotech, The Myeloma Foundation, and The Pastore Foundation.