[40] The IFM thus concluded that high-dose dexamethasone should not be routinely recommended as first-line therapy in elderly patients. The overall CR rates after induction therapy were similar with VMP and VTP, as were those after VT or VP maintenance. However, since the availability of new and more active drugs, several groups have compared in several phase III trials t … Typically, pamidronate or zoledronic acid is used. J Clin Oncol. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error.

Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study. However, considering the progress in non-intensive therapy, autologous transplantation should not currently be offered to elderly patients outside of a clinical trial. Mild kidney impairment resulting from diabetes or hypertension may be seen in elderly patients. ASCT use in older adults is the standard of care, is feasible, and is cost-effective. Tubular NF-κB and AP-1 activation in human proteinuric renal disease.

Prognostic factors for malignant transformation in monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. A simplified approach to the older patient who encompasses the practice of the authors. Hematologic recovery attained in this manner improves quality of life (transfusion-independence) and may make patients eligible for additional therapy, including clinical trials.

Durie BG, Hoering A, Sexton R, et al. Corticosteroids elevate blood pressure, making regimens such as Ld, which reduce the emphasis on corticosteroids, more desirable in hypertensive patients. Periodic cyclophosphamide is also a simple, inexpensive, and widely available choice. If CR is achieved with induction therapy, deferring AHSCT until disease progression occurs is a possible alternative to early AHSCT. 35. Kumar S, Rajkumar SV, Kyle RA, et al. One-year update of a phase 3 randomized study of daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) versus bortezomib, melphalan, and prednisone (VMP) in patients (pts) with transplant-ineligible newly diagnosed multiple myeloma (NDMM): ALCYONE. [7-12] The design of these studies, inclusion criteria, and doses of chemotherapy and thalidomide have varied (Table 1). In this study, both the thalidomide dosage (50 to 400 mg/d) and the dexamethasone dosage (4-day blocks at 40 mg/d) were probably too high in patients who were older than 75 or who had poor performance status; the elevated dosages might also explain the high incidence of early deaths from infection or cardiac complications. An effective alternative that is often tolerated better is prednisone. Randomized studies have shown the superiority of adding one novel agent to MP, either thalidomide (MPT) or bortezomib (MPV). However, up to now there has been no OS benefit in the lenalidomide maintenance arm.

Multiple myeloma (MM) is a clonal disorder of malignant plasma cells that comprises approximately 10% of hematologic malignancies. 38.  |  1 From a clinical perspective, MM is a highly symptomatic disease due to commonly occurring and often invalidating complications such as skeletal damage, … 2016 Mar;72(3):257-65. doi: 10.1007/s00228-015-1998-5.

Other measures are also important.

The dose of melphalan used is 140 to 200 mg/m2. The preliminary results of a study comparing MP and MPL induction with or without lenalidomide maintenance (MPL-L or MPL) showed that MPL-L was significantly superior to MP with higher response rates and PFS, and superior to MPL in terms of PFS.27  This indicates a beneficial effect of lenalidomide when added to MP induction and of lenalidomide maintenance when given after MPL. We commonly see patients who have “exhausted all treatment options” and have bone marrow failure secondary to disease burden and extensive therapy. Patients with myeloma frequently have symptoms and treatment toxicity that compromise health-related quality of life (HRQL).

MPV was superior in all prognostic subgroups, including patients with advanced age, impaired renal function, and high-risk cytogenetics.14,24  Adverse events were more common with MPV, neuropathy being a major concern. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA–Italian Multiple Myeloma Network. Hematology Am Soc Hematol Educ Program. Alternative medicine.

Multicenter, randomized, open-label phase III trial of lenalidomide-dexamethasone vs therapeutic abstention in smoldering myeloma at high risk of progression to symptomatic MM: results of the first interim analysis (abstract 614). The concomitant use of these drugs with a β-blocker should be avoided to decrease the risk of syncope. TABLE 3.

Elderly patients with multiple myeloma: towards a frailty approach? Dose-intensive melphalan with stem cell support (Mel 100) is superior to standard treatment in elderly myeloma patients. vs58%, respectively, Continuous therapy does not result in the emergence of more aggressive disease at relapse leading to worse survival outcomes, -In the MYELOMA XI trial, the percentage of patients gaining a mutation was slightly higher in the observation group than in the R group, and the number of mutation clusters at presentation and relapse was similar in the R group

In a pooled analysis of more than 1,100 older patients enrolled in clinical trials and treated with novel agents, early death rates were lower than historical comparisons, but deaths as a result of toxicity were still nearly as likely as deaths as a result of disease progression (4.1% vs. 4.4%).45 Of toxicity-related deaths during first-line of therapy, 28% were caused by cardiac complications; 26%, infections; and 15%, vascular complications. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. FIRSTtrial showed an improvement in depth of response with Rd continuous therapy One might speculate that higher doses of melphalan (0.25 mg/kg/d for 4 days every 6 weeks) and thalidomide (200 mg/d for 1 week, and up to 400 mg/d) and inclusion of older and more frail patients were the reason that a better response rate did not translate into a longer PFS in the MPT arm.

is a consultant with honoraria and membership of the Advisory Board, Janssen-Cilag, Takeda (Millennium), and Novartis honoraria, Celgene. This study compared lenalidomide plus high-dose dexamethasone (40 mg/d for 4 consecutive days, 3 times a month) with lenalidomide plus low-dose dexamethasone (40 mg weekly). Bortezomib, melphalan, prednisone and thalidomide (VMPT) followed by maintenance with bortezomib thalidomide (VT) for initial treatment of elderly multiple myeloma patients (abstract 8013). contact us. For patients 65 to 75 years who are not eligible for transplantation but can tolerate the increased toxicity profile of novel agents, classic MP is no longer standard treatment but should be combined with novel agents. Geriatrics is the study of health and disease in later life,11 wherein a comprehensive geriatric assessment (GA), although variably defined, is an interdisciplinary approach to identify, intervene, and create a longitudinal care plan to improve clinical outcomes for frail older adults.12,13 The term frailty “is used more frequently than it is defined” but is accepted to be a complex syndrome of physiologic decline that signifies increased vulnerability.14,15 As such, many myeloma providers have recognized the need to incorporate assessments of geriatric factors, given numerous treatment options and divergent intensities of therapeutic options. In the patient-centered view of high risk, focused on aging-associated vulnerabilities rather than on myeloma biology, adverse outcomes for which the patient may be at risk include early death, toxicity of therapy, functional decline, and other outcomes of interest in older adults. Three recent studies favor maintenance therapy in elderly patients. [14,39] Data involving lenalidomide are less clear. Presented at: 60th Annual Meeting of the American Society of Hematology. The median PFS was similar independent of age (22 months in age 80 or older vs. 22 and 21 months in patients age 75–79 and age 75 or younger, respectively). First analysis of HOVON-65/GMMG-HD4 randomized phase III trial comparing bortezomib, adriamycine, dexamethasone (PAD) vs VAD as induction treatment prior to high dose melphalan (HDM) in patients with newly diagnosed multiple myeloma (MM) [abstract]. Blood.

and S.S.) use it routinely in elderly patients if their renal function is marginal.

[26] Prognostic factors that are associated with a shorter time to progression are listed in Table 6. The resultant incremental cost-effectiveness ratio was $72,852 per life-year gained. This is effective if there is no treatment-induced or incidental myelodysplastic syndrome, which should be considered in patients with problematic cytopenias. Finally, if there is a very high likelihood of inability to tolerate the toxicity associated with combination therapy (usually in patients older than 80-85 years), the options are reduced-dose MP, corticosteroids alone at low to modest doses, or palliation. Palumbo A, Bringhen S, Petrucci MT, et al. The dose of thalidomide should not be more than 100 mg/d.[10]. here). 9. With median age of 66 at the time of presentation, multiple myeloma is predominantly a disease of the elderly. vs28.1 months for patients achieving VGPR, with Rd continuous therapy vs24.8 months, -MM-015trial, comparing MPR plus R continuous therapy Plasma cell myeloma is a clonal disorder of malignant plasma cells and is a disease of the elderly, with a median age of onset of 70 years. These are shown in Table 2 and can be summarized as follows: • Response rates-of either at least partial response or at least very good partial response (VGPR)-were significantly increased in the MPT arm in all five studies. It is important to take each patient's unique situation into consideration while devising a treatment plan. Until recently, combination chemotherapy with melphalan and prednisone (MP) has remained the most widely accepted treatment option for elderly patients with multiple myeloma (MM). This is not always true. Editorial Roster The dexamethasone dose may need to be reduced from 40 mg once a week to as little as 10 mg. An all-oral regimen, such as MPT or Ld, is more convenient than a bortezomib-containing combination.

An IMWG consensus panel analyzed the available evidence and concluded that patients with high-risk myeloma should be treated with a combination of a proteasome inhibitor and lenalidomide or pomalidomide along with dexamethasone. 2011 Dec;15(41):1-204. doi: 10.3310/hta15410. Older persons are more susceptible to bortezomib-induced thrombocytopenia and lenalidomide-induced myelosuppression. J Clin Oncol. [1] Age is an important prognostic factor in MM, and overall survival (OS) declines continuously by decade from age 50 to ages greater than 80. 45.

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