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Thromboembolic Events Associated With Novel Therapies in Patients With Multiple Myeloma: Consensus Statement of the IMF Nurse Leadership Board

Sandra Rome
Deborah Doss
Kena Miller
Jeanne Westphal
CJON 2008, 12(3), 21-28 DOI: 10.1188/08.CJON.S1.21-27

Patients with myeloma are at risk for serious and life-threatening thromboembolic events because of their disease, individual risk factors, and antimyeloma or other medications. The International Myeloma Foundation's Nurse Leadership Board developed this consensus statement for assessment and prevention of thromboembolic events. Prophylactic measures are categorized as mechanical, regimen related, and antithrombotic drug, based on individual and myeloma-related risk factors. Aspirin is suggested for patients with no or one risk factor, low-molecular-weight heparin or full-dose warfarin for patients with two or more risk factors, and low-molecular-weight heparin or full-dose warfarin for all patients with therapy-related risks, including high-dose dexamethasone, doxorubicin, or multiagent chemotherapy.

References 

Austin, H., Key, N. S., Benson, J. M., Lally, C., Dowling, N. F., Whitsett, C., et al. (2007). Sickle cell trait and the risk of venous thromboembolism among blacks. <i>Blood</i>, 110(3), 908-912.

Barlogie, B., Tricot, G., Rasmussen, E., Anaissie, E., van Rhee, F., Zangari, M., et al. (2005). Total therapy 3 (TT3) incorporating Velcade® (V) into upfront management of multiple myeloma (MM): Comparison with TT2 + thalidomide (T) [Abstract 1154]. <i>Blood</i>, 106, 1154.

Bertolotti, P., Bilotti, E., Colson, K., Curran, K., Doss, D., Faiman, B., et al. (2007). Nursing guidelines for enhanced patient care. <i>Haematologica</i>, 92(Suppl. 2), 211.

Bertolotti, P., Bilotti, E., Colson, K., Curran, K., Doss, D., Faiman, B., et al. (2008). Management of side effects of novel therapies for multiple myeloma: Consensus statements developed by the International Myeloma Foundation's Nurse Leadership Board. <i>Clinical Journal of Oncology Nursing</i>, 12(3, Suppl.), 9-12.

Bristol-Myers Squibb. (2007). Coumadin® (warfarin sodium) anticoagulant [Package insert]. Princeton, NJ: Author.

Caprini, J. A. (2006). <i>Venous thromboembolism risk factor assessment</i>. Retrieved October 22, 2007, from <a target="_blank" href='https://www.med.umich.edu/clinical/images/VTE-Risk-Assessment.pdf'>https...

Celgene Corporation. (2007a). Revlimid® (lenalidomide) [Package insert]. Summit, NJ: Author.

Celgene Corporation. (2007b). Thalomid® (thalidomide) [Package insert]. Summit, NJ: Author.

Coalition to Prevent Deep-Vein Thrombrosis. (2006). <i>Are you at risk for a DVT blood clot?</i> Retrieved September 18, 2007, from <a target="_blank" href='https://www.preventdvt.org/docs/pdf/DVTRiskAssessmentTool.pdf'>https://w...

Rajkumar, S. V., Hayman, S. R., Lacy, M. Q., Dispenzieri, A., Geyer, S. M., Kabat, B., et al. (2005). Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. <i>Blood</i>, 106(13), 4050-4053.

Richardson, P. G., & Anderson, K. (2006). Thalidomide and dexamethasone: A new standard of care for initial therapy in multiple myeloma. <i>Journal of Clinical Oncology</i>, 24(3), 334-335.

Richardson, P. G., Hideshima, T., Mitsiades, C., & Anderson, K. C. (2007). The emerging role of novel therapies for the treatment of relapsed myeloma. <i>Journal of the National Comprehensive Cancer Network</i>, 5(2), 149-162.

Bauer, K. A. (2001). The thrombophilias: Well-defined risk factors with uncertain therapeutic implications. <i>Annals of Internal Medicine</i>, 135(5), 367-373.

Baxter Healthcare. (2004). Heparin sodium injection, USP [Package insert]. Deerfield, IL: Author.

Bennett, C. L., Angelotta, C., Yarnold, P. R., Evens, A. M., Zonder, J. A., Raisch, D. W., et al. (2007). Thalidomide- and lenalidomide-associated thromboembolism among patients with cancer. <i>JAMA</i>, 296(2), 2558-2560.

Bennett, C. L., Hussain, Z., Courtney, M., Yarnold, P., Raisch, D., & McKoy, J. M. (2006). RADAR update on thalidomide (Thal)- and lenalidomide (Len)-associated venous thromboembolism (VTE): Safety concerns persist for multiple myeloma (MM) despite FDA approvals in this setting [Abstract 3310]. <i>Blood</i>, 108, 3310.

Durie, B. G., Richardson, P., Palumbo, A., Dimopoulos, M. A., Cavo, M., Hajek, R., et al. (2006). Deep vein thrombosis in myeloma: Estimate of prevalence and recommendations for therapy based upon a survey of members of the International Myeloma Working Group (IMWG) [Abstract 3751]. <i>Blood</i>, 108, 3571.

Ghobrial, J., Ghobrial, I. M., Mitsiades, C., Leleu, X., Hatjiharissi, E., Moreau, A. S., et al. (2007). Novel therapeutic avenues in myeloma: Changing the treatment paradigm. <i>Oncology</i>, 21(7), 785-792.

GlaxoSmithKline. (2005). Arixtra® (fondaparinux sodium) [Package insert]. Research Triangle Park, NC: Author.

Handin, R. I. (2005). Bleeding and thrombosis. In D. L. Kasper, A. S. Fauci, D. L. Longo, E. Baunwald, S. L. Hauser, J. L. Jameson, et al. (Eds.), <i>Harrison's principles of internal medicine</i> (16th ed., pp 1-24). New York: McGraw-Hill.

Harousseau, J. L., Jagannath, S., Richardson, P. G., Sonneveld, P., Schuster, M. W., Esseltine, D. L., et al. (2006). Bortezomib in combination with high-dose dexamethasone (HD dex) and erythropoietin (EPO) does not result in an increased risk of thromboembolic complications [Abstract]. <i>Blood</i>, 108, 3543.

Heit, J. A., O'Fallon, W. M., Petterson, T. M., Lohse, C. M., Silverstein, M. D., Mohr, D. N., et al. (2002). Relative impact of risk factors for deep vein thrombosis and pulmonary embolism. A population-based study. <i>Archives of Internal Medicine</i>, 162(11), 1245-1248.

Heit, J. A., Silverstein, M. D., Mohr, D. N., Petterson, T. M., O'Fallon, W. M., & Melton, J. (2000). Risk factors for deep vein thrombosis and pulmonary embolism. A population-based case-control study. <i>Archives of Internal Medicine</i>, 160(6), 809-815.

Hussein, M. (2006). Thromboembolism risk reduction in multiple myeloma patients treated with immunomodulatory combinations. <i>Thrombosis and Haemostasis</i>, 95(6), 924-930.

Joffe, H. V., Kucher, N., Tapson, V. F., & Goldhaber, S. Z. (2004). Upper-extremity deep vein thrombosis: A prospective registry of 592 patients. <i>Circulation</i>, 110(12), 1605-1611.

Khorana, A. A., Francis, C. W., Culakova, E., Fisher, R. I., Kuderer, N. M., & Lyman, G. H. (2006). Thromboembolism in hospitalized neutropenic cancer patients. <i>Journal of Clinical Oncology</i>, 24(3), 484-490.

Knight, R., DeLap, R. J., & Zeldis, J. B. (2006). Lenalidomide and venous thrombosis in multiple myeloma. <i>New England Journal of Medicine</i>, 354(19), 2079-2080.

Lonial, S., Richardson, P. G., San Miguel, J., Sonneveld, P., Schuster, M., Blade, J., et al. (2007). Hematologic profiles with bortezomib in relapsed MM. <i>Haematologica</i>, 92(Suppl. 2), 159-160. Retrieved April 10, 2008, from http://www.haematologica.it/content/vol92/6_supplement_2/index.dtl <a target="_blank" href='http://www.haematologica.it/content/vol92/6_supplement_2/index.dtl'>http...

Manochakian, R., Miller, K. C., & Chanan-Khan, A. A. (2007). Clinical impact of bortezomib in frontline regimens for patients with multiple myeloma. <i>Oncologist</i>, 12(8), 978-990.

Millennium Pharmaceuticals, Inc. (2007). Velcade® (bortezomib) [Package insert]. Cambridge, MA: Author.

Miller, K., Padmanabhan, S., Dimicelli, L., Depaolo, D., Landrigan, B., Yu, J., et al. (2006). Prospective evaluation of low-dose warfarin for prevention of thalidomide associated venous thromboembolism. <i>Leukemia and Lymphoma</i>, 47(11), 2339-2343.

National Cancer Institute. (2006). <i>Common Terminology Criteria for Adverse Events v.3.0.</i> Retrieved August 8, 2007, from <a target="_blank" href='http://ctep.cancer.gov/forms/CTCAEv3.pdf'>http://ctep.cancer.gov/forms/C...

National Comprehensive Cancer Network. (2007). <i>NCCN Clinical Practice Guidelines in Oncology<sup>™</sup>: Venous thromboembolic disease</i> [v.1.2007]. Retrieved September 10, 2007, from <a target="_blank" href='http://www.nccn.org/professionals/physician_gls/PDF/vte.pdf'>http://www....

Offidani, M., Corvatta, L., Marconi, M., Visani, G., Alesiani, F., Brunori, M., et al. (2005). Thalidomide, dexamethasone and pegylated-liposomal doxorubicin (ThaDD) for untreated multiple myeloma patients aged over 65 years [Abstract 2558]. <i>Blood</i>, 106, 2558.

Ortho Biotech Products, L. P. (2007). Doxil® (doxorubicin HCl liposome injection) [Package insert]. Bridgewater, NJ: Author.

Otten, H. M., Mathijssen, J., ten Cate, H., Soesan, M., Inghels, M., Richel, D. J., et al. (2004). Symptomatic venous thromboembolism in cancer patients treated with chemotherapy. <i>Archives of Internal Medicine</i>, 164(2), 190-194.

Palumbo, A., Rajkumar, S. V., Dimopoulos, M. A., Richardson, P. G., San Miguel, J., Barlogie, B., et al. (2008). Prevention of thalidomide- and lenalidomide-associated thrombosis in myeloma. <i>Leukemia</i>, 22(2), 414-423.

Pfizer, Inc. (2007). Fragmin® (dalteparin sodium injection) [Prescribing information]. New York: Author.

Prandoni, P. (2005). Acquired risk factors for venous thromboembolism in medical patients. <i>Hematology</i>, 1, 458-461.

Prandoni, P., Falanga, A., & Piccioli, A. (2005). Cancer and venous thromboembolism. <i>Lancet Oncology</i>, 6(6), 401-410.

Qaseem, A., Snow, V., Barry, P., Hornbake, E. R., Rodnick, J. E., Tobolic, T., et al. (2007). Current diagnosis of venous thromboembolism in primary care: A clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. <i>Annals of Family Medicine</i>, 5(1), 57-62.

Rajkumar, S. V., & Gertz, M. A. (2006). Response (to Zonder et al., <i>Blood</i> 2006): Lenalidomide therapy and deep-vein thrombosis in multiple myeloma [Letter to the editor]. <i>Blood</i>, 108, 404.

Richardson, P. G., Jagannath, S., Avigan, D. E., Alsina, M., Schlossman, R. L., Mazumder, A., et al. (2006). Lenalidomide plus bortezomib (Rev-Vel) in relapsed and/or refractory multiple myeloma (MM): Final results of a multicenter phase 1 trial [Abstract 405]. <i>Blood</i>, 108, 405.

sanofi-aventis. (2007). Lovenox® (enoxaparin sodium injection) [Package insert]. Bridgewater, NJ: Author.

Spencer, F. A., Lessard, D., Emery, C., Reed, G., & Goldberg, R. J. (2007). Venous thromboembolism in the outpatient setting. <i>Archives of Internal Medicine</i>, 167(14), 1471-1475.

Story, K. T. (2006). Deep venous thrombosis. In D. Camp-Sorrell, & R. A. Hawkins (Eds.), <i>Clinical manual for the oncology advanced practice nurse</i>. (2nd ed., pp. 281-290). Pittsburgh, PA: Oncology Nursing Society.

Van Gerpen, R., & Mast, M. E. (2004). Thromboembolic disorders in cancer. <i>Clinical Journal of Oncology Nursing</i>, 8(3), 289-299.

Viale, P. H., & Schwartz, R. N. (2004). Venous thromboembolism in patients with cancer. Part I. Survey of oncology nurses' attitudes and treatment practices for ambulatory settings. <i>Clinical Journal of Oncology Nursing</i>, 8(5), 455-461.

Zangari, M., Siegal, E., Barlogie, B., Anaissie, E., Saghafifar, F., Fassas, A., et al. (2002). Thrombogenic activity of doxorubicin in myeloma patients receiving thalidomide: Implications for therapy. <i>Blood</i>, 100(4), 1168-1171.

Zonder, J. A., Barlogie, B., Durie, B. G. M., McCoy, J., Crowley, J., & Hussein, M. A. (2006). Thrombotic complications in patients with newly diagnosed multiple myeloma treated with lenalidomide and dexamethasone: Benefit of aspirin prophylaxis. <i>Blood</i>, 108(1), 403.