nccn multiple myeloma guidelines

nccn multiple myeloma guidelines

Other agents available for myeloma therapy should be used with caution and with dose adjustments based on the degree of renal function impairment, as recommended by the IMWG.49 A retrospective study evaluated lenalidomide and dexamethasone based on 2 phase III trials of lenalidomide/low-dose dexamethasone in patients with relapsed/refractory myeloma and a serum creatinine level of <2.5 mg/dL.50 Patients grouped by creatinine clearance >60 mL/min (n=243), 30 to 60 mL/min (n=82), and <30 mL/min (n=16) showed no difference in response rates to lenalidomide/low-dose dexamethasone. Those with renal insufficiency had higher rates of thrombocytopenia and lenalidomide discontinuation than those without renal insufficiency. Anderson KC, Alsina M, Atanackovic D, Biermann JS, Chandler JC, Costello C, Djulbegovic B, Fung HC, Gasparetto C, Godby K, Hofmeister C, Holmberg L, Holstein S, Huff CA, Kassim A, Krishnan AY, Kumar SK, Liedtke M, Lunning M, Raje N, Reu FJ, Singhal S, Somlo G, Stockerl-Goldstein K, Treon SP, Weber D, Yahalom J, Shead DA, Kumar R. J Natl Compr Canc Netw. Epub 2016 May 9. Eur J Haematol 1994;53:207–212. Bringhen S, Mina R, Petrucci MT, . Epub 2014 Jul 22. van de Donk NW, Mutis T, Poddighe PJ, Lokhorst HM, Zweegman S. Int J Lab Hematol. Intravenous fluids should be started promptly in patients with MM and renal disease to decrease the renal tubular light chain concentration, with a goal urine output of 100 to 150 mL/h. F18-fluorodeoxyglucose positron emission tomography in the context of other imaging techniques and prognostic factors in multiple myeloma. Knudsen LM, Hjorth M, Hippe E. Renal failure in multiple myeloma: reversibility and impact on the prognosis. PET/CT improves the definition of complete response and allows to detect otherwise unidentifiable skeletal progression in multiple myeloma. The NCCN Guidelines Insights do not represent the full NCCN Guidelines; further, the National Comprehensive Cancer Network® (NCCN®) makes no representations or warranties of any kind regarding their content, use, or application of the NCCN Guidelines and NCCN Guidelines Insights and disclaims any responsibility for their application or use in any way. Footnote e added here and as appropriate throughout the guidelines: See Principles of Imaging (MYEL-B). Select appropriate evidence-based strategies for management of patients with newly diagnosed multiple myeloma, taking individual patient characteristics into consideration; Evaluate clinical data supporting the current treatment options for patients with relapsed/refractory multiple myeloma; Additional information . Because the disease burden in patients with smoldering myeloma is lower than in those with MM, imaging techniques with high sensitivity must be used, and MRI is a sensitive technique for detecting marrow infiltration by myeloma.12,13. J Clin Oncol 2007;25:1121–1128. Eur Radiol 2008;18:51–58. The carfilzomib/cyclophosphamide/dexamethasone regimen has been studied in phase I/II trials of transplant-ineligible patients with newly diagnosed MM. Chari A, Vogl DT, Gavriatopoulou M, . Eur J Nucl Med Mol Imaging 2006;33:525–531. Clin Cancer Res 2015;21:4384–4390. This study found that that 56 mg/m2 of carfilzomib combined with weekly cyclophosphamide and dexamethasone was effective and had manageable toxicity.25. According to the NCCN panel, diagnostic workup of patients with symptomatic myeloma should include serum creatinine measurement, electrolytes assessment, eGFR, electrophoresis of a sample from a 24-hour urine collection, serum electrophoresis, and serum free light chain measurement. NCCN Guidelines Version 3.2017 Multiple Myeloma NCCN Guidelines Index Table of Contents Discussion Note: All recommendations are category 2A unless otherwise indicated. Haematologica 2016;101:e415–418. This activity is supported by educational funding provided by Amgen. © National Comprehensive Cancer Network, Inc. 2019. Renal failure in multiple myeloma: presenting features and predictors of outcome in 94 patients from a single institution. Michaela Liedtke, MD, Panel Member, has disclosed that she receives consulting fees/honoraria from Amgen, and serves as a scientific advisor for Celgene Corporation, Janssen Pharmaceutica Products, LP, and Jazz Pharmaceuticals Inc. Alyse Johnson-Chilla, MS, Guidelines Coordinator, NCCN, has disclosed that she has no relevant financial relationships. In addition, concomitant amyloidosis and monoclonal immunoglobulin deposition should be suspected when renal insufficiency or albuminuria is present without high levels of light chains. Given the high-level data, the NCCN panel continues to list single-agent lenalidomide as a category 1 preferred maintenance regimen for both transplant-eligible and transplant-ineligible patients (see MYEL-F, pages 1159–1161). Lancet 2019;393:253–264. Multiple Myeloma, Version 3.2017, NCCN Clinical Practice Guidelines in Oncology Multiple myeloma (MM) is caused by the neoplastic proliferation of plasma cells. The panel also noted that skeletal survey is acceptable when advanced imaging is not available. The updated NCCN Guidelines for Multiple Myeloma feature several changes in the diagnosis and management of this disease. The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, workup, treatment, follow-up, and supportive care for patients with monoclonal gammopathy of renal significance, solitary plasmacytoma, smoldering myeloma, and multiple myeloma. 2021 Feb 15;10(2):153. doi: 10.3390/biology10020153. Accessibility eCollection 2021. Renal disease is seen in 20% to 50% of patients with myeloma and has been observed to negatively affect outcomes.45–47 In the 1.2020 version of the NCCN Guidelines, the panel added a new page outlining management of renal disease in MM (see MYEL-H, page 1162). This informational program was created in conjunction with the recently updated NCCN Guidelines for Patients ® for Multiple Myeloma. Br J Haematol 2019;184:536–546. Blood 2014;124:63–69. Combination of flow cytometry and functional imaging for monitoring of residual disease in myeloma, Low expression of hexokinase-2 is associated with false-negative FDG-positron emission tomography in multiple myeloma, Daratumumab plus lenalidomide and dexamethasone for untreated myeloma, Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study, Phase 1/2 study of weekly carfilzomib, cyclophosphamide, dexamethasone in newly diagnosed transplant-ineligible myeloma, Once-weekly versus twice-weekly carfilzomib in patients with newly diagnosed multiple myeloma: a pooled analysis of two phase I/II studies, A multicenter, open-label, phase 1b study of carfilzomib, cyclophosphamide, and dexamethasone in newly diagnosed multiple myeloma patients (CHAMPION-2), Phase 1/2 trial of ixazomib, cyclophosphamide and dexamethasone in patients with previously untreated symptomatic multiple myeloma, All-oral ixazomib, cyclophosphamide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma, Lenalidomide maintenance after stem-cell transplantation for multiple myeloma, Lenalidomide after stem-cell transplantation for multiple myeloma, Continuous lenalidomide treatment for newly diagnosed multiple myeloma, Updated outcomes and impact of age with lenalidomide and low-dose dexamethasone or melphalan, prednisone, and thalidomide in the randomized, phase III FIRST trial, Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial, Lenalidomide maintenance after autologous stem-cell transplantation in newly diagnosed multiple myeloma: a meta-analysis, Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial, Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma: results of the randomized phase III HOVON-65/GMMG-HD4 trial, Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial, Phase 3b UPFRONT study: safety and efficacy of weekly bortezomib maintenance therapy after bortezomib-based induction regimens in elderly, newly diagnosed multiple myeloma patients [abstract], Consolidation and maintenance therapy with lenalidomide, bortezomib and dexamethasone (RVD) in high-risk myeloma patients, Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial, Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma, Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma, Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial, A phase I/II trial of cyclophosphamide, carfilzomib, thalidomide and dexamethasone (CYCLONE) in patients with newly diagnosed multiple myeloma: final results of MTD expansion cohort, Oral selinexor-dexamethasone for triple-class refractory multiple myeloma, Renal failure in multiple myeloma: presenting features and predictors of outcome in 94 patients from a single institution, Renal function in newly diagnosed multiple myeloma—a demographic study of 1353 patients, Renal failure in multiple myeloma: reversibility and impact on the prognosis, Bortezomib-based triplets are associated with a high probability of dialysis independence and rapid renal recovery in newly diagnosed myeloma patients with severe renal failure or those requiring dialysis, International Myeloma Working Group recommendations for the diagnosis and management of myeloma-related renal impairment, Lenalidomide and dexamethasone for the treatment of refractory/relapsed multiple myeloma: dosing of lenalidomide according to renal function and effect on renal impairment, Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and renal impairment: results from a phase II trial, High-dose chemotherapy and autologous peripheral blood stem cell transplantation in patients with multiple myeloma and renal insufficiency, Autologous hematopoietic cell transplantation for multiple myeloma patients with renal insufficiency: a Center for International Blood and Marrow Transplant Research Analysis, Disclosure of Relevant Financial Relationships. Shaji K. Kumar, MD, Panel Chair, has disclosed that he receives consulting fees/honoraria from Adaptive Technologies and Oncopeptides. J Natl Compr Canc Netw. The panel recommends a baseline dental exam and monitoring for ONJ in all patients receiving a bone-modifying agent and monitoring for renal … NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Multiple Myeloma Version 1.2011 NCCN.org The NCCN Guidelines™ are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. The doublet regimens were removed from the page listing therapies for transplant candidates with the rationale that doublets would be recommended for patients who would not be considered for initial treatment with a 3-drug regimen, such as those not initially eligible for transplant. Carfilzomib in Combination with Bortezomib Enhances Apoptotic Cell Death in B16-F1 Melanoma Cells. Individuals Who Provided Content Development and/or Authorship Assistance: Updates to Treatment Options for Newly Diagnosed MM, Carfilzomib/Cyclophosphamide/Dexamethasone, NCCN Recommendations for Primary Myeloma Therapy, Updates to Maintenance Therapy Recommendations, NCCN Recommendations for Lenalidomide Maintenance, NCCN Recommendations for Bortezomib Maintenance, NCCN Recommendations for Ixazomib Maintenance, Updates to Treatment Options for Previously Treated MM, Carfilzomib/Cyclophosphamide/Thalidomide/Dexamethasone, Management of Renal Disease in Patients With MM, NCCN CATEGORIES OF EVIDENCE AND CONSENSUS, NCCN.org/disclosures/guidelinepanellisting.aspx, http://seer.cancer.gov/statfacts/html/mulmy.html. Conditioning with reduced-dose melphalan has outcomes comparable to standard-dose melphalan and should be considered in those who are otherwise eligible for the procedure.52,53. Multiple myeloma is a malignant neoplasm of plasma cells that accumulate in bone marrow, leading to bone destruction and marrow failure. Predictive value of longitudinal whole-body magnetic resonance imaging in patients with smoldering multiple myeloma. Hillengass J, Fechtner K, Weber MA, . Based on the positive results of the TOURMALINE-MM3 trial, designed specifically to study the benefit of maintenance ixazomib, the NCCN panel included ixazomib as a category 1 “Other Recommended” maintenance option for transplant-eligible patients (see MYEL-F, pages 1159–1161). eCollection 2021. Siegel RL, Miller KD, Jemal A. Dialysis may be required in selected patients, in addition to prompt institution of antimyeloma therapy. The NCCN Guidelines are in continuous evolution; they are updated annually, and sometimes more often if new high-quality clinical data become available in the interim. Nooka AK, Kaufman JL, Muppidi S, . The updated criteria for the diagnosis of myeloma represent a paradigm shift in the approach to myeloma and have considerable impact on the management of the disease. If the inline PDF is not rendering correctly, you can download the PDF file here. All-oral ixazomib, cyclophosphamide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Autologous hematopoietic cell transplantation for multiple myeloma patients with renal insufficiency: a Center for International Blood and Marrow Transplant Research Analysis. Multiple myeloma will account for an estimated 16,570 new cancer cases in the United States in 2006, with an estimated 11,310 deaths. Results of the phase I/II CYCLONE trial showed that the 4-drug carfilzomib/cyclophosphamide/thalidomide/dexamethasone regimen is efficacious, with an overall response rate of 91%, and 76% of patients with MM achieving a VGPR or greater after 4 cycles.43 This regimen has now been included under the list of regimens “Useful in Certain Circumstances” for relapsed/refractory MM. These NCCN Guidelines Insights focus only on the updates specific to imaging recommendations for MM; treatment options for newly diagnosed transplant-eligible and transplant-ineligible candidates, maintenance therapy, and previously treated MM; and management of renal disease in patients with MM. Lenalidomide after stem-cell transplantation for multiple myeloma. 2014 Oct;28(5):775-90. doi: 10.1016/j.hoc.2014.06.005. Mechanical removal of light chains may be considered on a case-by-case basis. If you have any questions, please e-mail education@nccn.org. New regimens were included as options for the treatment of relapsed/refractory MM in the 1.2020 version of the NCCN Guidelines (see MYEL-F, pages 1159–1161). He J, Schmerold L, Van Rampelbergh R, Qiu L, Potluri R, Dasgupta A, Li L, Li Y, Hu P, Nemat S, Smugar SS, Zeltzer P, Appiani C, Li Q, Mehra M, Richarz U. Adv Ther. Results were recently published of the phase III, open-label, multicenter, randomized OPTIMISMM study that evaluated the safety and efficacy of pomalidomide/bortezomib/dexamethasone (n=281) versus bortezomib/dexamethasone (n=278) in patients with relapsed/refractory MM who previously received lenalidomide.42 After a median follow-up of 15.9 months, significantly improved PFS was seen in the pomalidomide arm (median, 11.20 vs 7.10 months; HR, 0.61; 95% CI, 0.49–0.77; P42. Clin Lymphoma Myeloma Leuk 2017;17:433–437. Your credit cannot be reported without this information. J Clin Oncol 2016;34:3609–3617. In patients with renal disease, pamidronate and zoledronic acid should be used with caution; the NCCN panel has provided recommended dosing of these agents (see MYEL-H, page 1162). The NCCN Multiple Myeloma Panel has developed guidelines for the management of patients with various plasma cell neoplasms, including solitary plasmacytoma, smoldering myeloma, multiple myeloma, systemic light chain amyloidosis, and Waldenström macroglobulinemia. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of “The NCCN Guidelines underscore how far we have come in treating myeloma,” said Myeloma Crowd founder Jenny Ahlstrom. Hillengass J, Moulopoulos LA, Delorme S, . Leukemia 2014;28:1902–1908. Baseline bone involvement in multiple myeloma—a prospective comparison of conventional x-ray, low-dose computed tomography, and 18flourodeoxyglucose positron emission tomography in previously untreated patients. N Engl J Med 2019;380:2104–2115. Blood 2009;114:2068–2076. Mellqvist UH, Gimsing P, Hjertner O, . Hinge M, Andersen KT, Lund T, . Also, because regimens containing melphalan are rarely used in North America, daratumumab in combination with bortezomib/lenalidomide/dexamethasone has now been listed under “Other Recommended Regimens” in this setting. Lenalidomide maintenance after autologous stem-cell transplantation in newly diagnosed multiple myeloma: a meta-analysis. The National Comprehensive Cancer Network (NCCN) guidelines for the management of frontline and relapsed/refractory multiple myeloma were … Monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. The NCCN Guidelines are a statement of consensus of the authors regarding their views of currently accepted approaches to cancer treatment. The panel added new regimen options in the 1.2020 version for both transplant-eligible and transplant-ineligible patients with newly diagnosed MM. Hydration, bisphosphonates, denosumab, and/or calcitonin are recommended to reduce calcium levels in the case of hypercalcemia. The choice of appropriate therapy for a patient would depend on the context of clinical relapse, such as prior treatment and duration of response. All recommendations are category 2A unless otherwise noted. Dimopoulos MA, Sonneveld P, Leung N, . Updates in Version 1.2020 of the NCCN Guidelines for Multiple Myeloma from Version 3.2019 include: been done performed, then skeletal survey is not needed. However, treatment algorithms based on published data, as well as clinical experience, can be … Boccia RV, Bessudo A, Agajanian R, . Mikhael JR, Reeder CB, Libby EN, . Updates in Version 2.2014 of the NCCN Guidelines for Multiple Myeloma from Version 1.2014 include: NCCN Guidelines Version 2.2014 Multiple Myeloma - Updates MYEL-3 Added the following footnote to Smoldering (asymptomatic) myeloma: “A relatively small randomized prospective study has shown benefit of early treatment with lenalidomide and dexamethasone for a subset of patients with … Clinicians must understand the treatment evolution and guidelines for administration of available therapies in the … Eur J Haematol 2000;65:175–181. NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018. However, in small cohorts, functional imaging sequence for MRI called diffusion-weighted imaging was shown to have superior sensitivity to detect residual disease compared with FDG-PET/CT.18–20 Furthermore, unlike FDG-PET/CT, MRI does not expose patients to radiation. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. Cost-Effectiveness Analysis of Adding Daratumumab to Bortezomib, Melphalan, and Prednisone for Untreated Multiple Myeloma. Blood 2019;134:421–431. Blood 2010;116:Abstract 619. Footnote f added: CD138 positive selected sample is strongly Bone Marrow Transplant 1997;20:653–656. The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, workup, treatment, follow-up, and supportive care for patients with monoclonal gammopathy of renal significance, solitary plasmacytoma, smoldering myeloma, and multiple myeloma. At last week’s NCCN Virtual Annual Conference, Shaji K. Kumar, MD, of the Mayo Clinic Cancer Center, who chairs the guidelines committee on multiple myeloma… Continuous lenalidomide treatment for newly diagnosed multiple myeloma. Kröpil P, Fenk R, Fritz LB, . MRI is useful for discerning smoldering myeloma from MM. Significant updates have been made to the 1.2020 version of the NCCN Guidelines for Multiple Myeloma. Holstein SA, Jung SH, Richardson PG, . Residual focal lesions detected by either FDG-PET/CT or MRI have been shown to be of adverse prognostic significance.14–17 Zamagni et al17 reported progression-free survival (PFS) of 44 months in patients with residual focal lesions on FDG-PET/CT versus 84 months for those with no residual focal lesions after systemic treatment (P=.0009). These NCCN Guidelines Insights highlight s … This manuscript discusses the management of patients with solitary plasmacytoma, smoldering multiple myeloma, and newly diagnosed multiple myeloma. Cancer Stat Facts: Myeloma. Prevention and treatment information (HHS). Partial response or better was observed in 26% of patients (95% CI, 19%–35%). CA Cancer J Clin 2017;67:7–30. The heterogeneity of relapsed/refractory multiple myeloma (MM) and an increasing number of therapeutic options in this setting has resulted in a complex environment for treatment decisions. The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, evaluation, treatment, including supportive care, and follow-up for patients with myeloma. Maintenance with proteasome inhibitors has also been evaluated in randomized trials. These NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) are updated annually, Myeloma therapy using bortezomib-containing regimens should be initiated as soon as possible to decrease the production of nephrotoxic clonal immunoglobulin.48 Bortezomib/dexamethasone containing regimens can be administered to patients with severe renal impairment and those on dialysis and do not require renal dose adjustment.46 If the 2-drug bortezomib/dexamethasone regimen is used as initial treatment, a third drug that does not require dose adjustment can be added, including cyclophosphamide, thalidomide, an anthracycline, or daratumumab. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. For high-risk patients, the panel considers bortezomib/lenalidomide an option for maintenance therapy, and therefore has included this combination as “Useful in Certain Circumstances.”38. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. Leukemia 2014;28:690–693. Oncopeptides announces that PEPAXTO® is included in new Multiple Myeloma guidelines of National Comprehensive Cancer Network® News provided by. In patients with MM and monoclonal gammopathies, renal disease usually results from the production of monoclonal immunoglobulin or light/heavy chains by a clonal proliferation of plasma cells or B cells. Rasche L, Alapat D, Kumar M, . Facon T, Kumar S, Plesner T, . Pawlyn C, Fowkes L, Otero S, . NCCN: Multiple myeloma. Positron emission tomography-computed tomography in the diagnostic evaluation of smoldering multiple myeloma: identification of patients needing therapy. A skeletal survey has been the standard for assessing bone disease in any individual with suspected myeloma for decades.4 However, this technique has significant limitations related to lower sensitivity compared with advanced imaging. N Engl J Med 2019;381:727–738. Although prospective data to define optimal dosing are often lacking, pomalidomide has been studied in patients with relapsed myeloma in 3 different categories of renal insufficiency (eGFR 30–40 mL/min/1.73 m2, eGFR <30 mL/min/1.73 m2, and those requiring dialysis), and full-dose pomalidomide of 4 mg/d was found to be safe in all 3 groups.51 High-dose chemotherapy and autologous stem cell transplantation can be safely performed in patients with renal insufficiency, including those on dialysis.

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