Changing Patient Care in Multiple Myeloma PowerPoint Presentation

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1 Changing Patient Care in Multiple Myeloma: The IMF Nurse Leadership Board’s Long-Term Survivorship Care Plan Accredited by Medical Education Resources Supported by The International Myeloma Foundation Grant Funding Provided by Celgene Corporation and Millennium – The Takeda Oncology Company May 13, 2010 San Diego

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2 Welcome and Introductions Elizabeth Bilotti, RN, MSN, APRN, BC The John Theurer Cancer Center at Hackensack University Medical Center Hackensack, NJ

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3 ONS Disclaimer Meeting space has been assigned to provide a satellite symposium supported by the International Myeloma Foundation via an unrestricted educational grant during the Oncology Nursing Society’s (ONS) 35th Annual Congress, May 13 - May 16, 2010, in San Diego, CA. The Oncology Nursing Society’s assignment of meeting space does not imply product endorsement, nor does the Oncology Nursing Society assume any responsibility for the educational content of the symposium.

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4 Symposium Accreditation This continuing education activity provides 1.5 contact hours. Medical Education Resources is an approved provider of continuing nursing education by the Colorado Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. Please complete the CE Certificate Registration and Program Evaluation Form found in your guidebook and return it to the registration desk at the conclusion of this meeting.

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5 Faculty Chair: Elizabeth Bilotti, RN, MSN, APRN, BC John Theurer Cancer Center at Hackensack University Medical Center Hackensack, NJ Faculty: Beth Faiman, MSN, APRN-BC, AOCN® Cleveland Clinic Taussig Cancer Institute Cleveland, OH Teresa Miceli, RN, BSN, OCN® Mayo Clinic - Rochester Rochester, MN Tiffany Richards, MS, ANP, AOCNP® MD Anderson Cancer Center Houston, TX Joseph D. Tariman, PhC, MN, APRN, BC University of Washington Seattle, WA

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6 Agenda

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7 Learning Objectives Update on current therapies used in the management of patients with multiple myeloma (MM) Provide new data on emergent therapies in MM Understand how longer survival may lead to a new care paradigm for MM patients Understand the rationale and value of a Long-Term Survivorship Care Plan Outline the role that nurses play in the implementation of a Survivorship Care Plan Discuss medical implications of major long-term side effects associated with novel therapies in MM

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8 Multiple Myeloma: Epidemiology NCCN Multiple Myeloma Guidelines, v.3.2010; Cancer Facts and Figures, 2009; SEER Stat Fact Sheets, Myeloma (http://seer.cancer.gov/csr/1975_2006/results_merged/sect_18_myeloma.pdf)

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9 San Miguel JF, et al. Pathogenesis of Multiple Myeloma: Rationale for New and Novel Therapies. Clinical Care Options: http://clinicaloptions.com/Oncology/Treatment%20Updates/Myeloma/Modules/Pathophysiology/Pages/Page%203.aspx. Multiple Myeloma: Disease State Cancer of plasma cells Healthy plasma cells produce antibodies or immunoglobulins Part of our humoral immunity, they are released in response to foreign body invasion

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10 Multiple Myeloma: Abnormal Plasma Cells Multiple Myeloma (bone marrow aspirate) http://www.healthsystem.virginia.edu/internet/hematology/HessEDD/MalignantHematologicDisorders/MultipleMyelomas/Multiple-myeloma.cfm Large nuclei (often eccentric) are present in multiple myeloma cells.

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11 Multiple Myeloma Cells Overproduce Monoclonal Protein and Abnormal Immunoglobulin Kyle and Rajkumar, N Engl J Med 2004;351:1860-1873 Ineffective immune function Decreased normal bone marrow function Impaired renal function

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12 Clinical Manifestations of Multiple Myeloma Overproliferation of plasma cells can cause: http://myeloma.org/pdfs/ph07-eng_f2.pdf

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13 Major Symptoms at Diagnosis Kyle RA. Mayo Clin Proc 2003;78:21

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14 Common Sites for Bone Involvement Skull Spine Thoracic Lumbar Vertebrae Pelvis Long bones http://www.emedicine.com/Radio/topic460.htm#section~Introduction

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15 Diagnosing Multiple Myeloma Durie et al for the International Myeloma Working Group. Leukemia. 2006:1-7. *Monoclonal M spike on electrophoresis IgG >3.5 g/dL, IgA >2 g/dL, light chain >1 g/dL in 24-hour urine sample.

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16 Diagnostic Evaluation of Multiple Myeloma Alb = albumin; CBC = complete blood count; Creat = creatinine; Hgb = hemoglobin; MRI = magnetic resonance imaging; WBC = white blood cell Abella. Oncology News International. 2007;16:27; Barlogie et al. In: Williams Hematology. 7th ed. 2006:1501; Durie et al. Hematol J. 2003;4:379; MMRF. Multiple Myeloma: Disease Overview. 2006. www.multiplemyeloma.org; Rajkumar et al. Blood. 2005;106(3):812.

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17 Durie-Salmon Staging System for Multiple Myeloma Durie and Salmon, Cancer 1975;36(9):842-854

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18 2M=serum 2 microglobulin in mg/dL; ALB=serum albumin in g/dL Greipp PR, et al. Blood 2005; 102: 190a Multiple Myeloma Staging: International Staging System for Symptomatic MM ISS should only be used in patients who meet diagnostic criteria for myeloma since other conditions (renal dysfunction from diabetes or hypertension) may cause elevated B2M levels ISS is more of a prognostic index; it does not quantify tumor burden or extent of involvement It is recommended that ISS staging be used along with the Durie-Salmon Staging System

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19 Challenges in MM Management New treatment options are currently in development with the goal to further improve outcomes NCCN Practice Guidelines v.3.2010; Kumar et al, Blood 111(5), 2008 Median overall survival for newly diagnosed patients is ~3.7 years Long-term complete responses are rare Currently incurable in most patients ASCT may prolong progression-free survival, but it’s not curative Newer drugs improved survival to up to ~2.6 years from relapse

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20 MM Treatment Options

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21 Update on Current Therapies for the Treatment of Multiple Myeloma Beth Faiman, MSN, APRN-BC, AOCN® Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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22 Multi-Drug Combinations in Multiple Myeloma

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23 NCCN Review Categories NCCN Clinical Practice Guidelines in Oncology, v.3.2010 Generic Name Trade Name Company Bortezomib Velcade Millennium - Takeda Lenalidomide Revlimid Celgene Thalidomide Thalomid Celgene *Combinations recently reviewed by NCCN

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24 NCCN: Changing Categories of Consensus Change is a natural process secondary to the constant stream of data from recent clinical studies Categories 2A and 2B are not indicative of inferiority of the treatment: …non-uniform consensus does not represent a major disagreement, rather it recognizes that given imperfect information, institutions may adopt different approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from the existing data… NCCN, “Categories of Evidence and Consensus”, 2010 NCCN, “Categories of Evidence and Consensus”, 2010

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25 Revised Categories of Evidence and Consensus – NCCN Guidelines, 2010 NCCN Clinical Practice Guidelines in Oncology, v.3.2010 NCCN Categories of Evidence and Consensus: 1 High-level evidence, uniform consensus 2A Lower-level evidence, uniform consensus 2B Lower-level evidence, non-uniform consensus

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26 Future of MM Therapy: Recent and Ongoing Clinical Studies Transplant-ineligible patients VMP – VT vs. VTP – VP VMPT – VT vs. VMP MP vs. MPT MP vs. MPR vs. MPR (continued lenalidomide) Lenalidomide/dexamethasone in smoldering myeloma QUIREDEX Study New combinations and early studies EVOLUTION Study Pomalidomide/low dexamethasone Carfilzomib Carfilzomib/lenalidomide/dexamethasone Elotuzumab/lenalidomide/dexamethasone Transplant-eligible patients Lenalidomide after ASCT MPR vs. high-dose melphalan Patient Treatment Largely Determined by Transplant Status ASCO 2009; ASH 2009

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27 VMP vs. VTP Followed by VT vs. VP (ASH 2009 - PLENARY SESSION) Mateos et al, Blood 114, Abstract 3, 2009 Study objective: Testing an alkylating agent (melphalan) and an immunomodulatory drug (thalidomide) as a partner for bortezomib Study design: Prospective, multicenter, randomized Induction: patients randomized to 6 cycles of VMP vs. VTP Maintenance: patients randomized to VT vs. VP for up to 3 years A Phase 3 Study of Bortezomib/Melphalan/Prednisone (VMP) vs. Bortezomib/Thalidomide/Prednisone (VTP) Followed by Bortezomib/Thalidomide (VT) vs. Bortezomib/Prednisone (VP) in Elderly Newly Diagnosed Multiple Myeloma (NDMM) Patients

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28 Conclusions from VMP – VT vs. VTP – VP Both induction schedules are highly effective with similar overall response rate (ORR) and complete response (CR) More neutropenia but less cardiac toxicity and peripheral neuropathy with VMP Both maintenance therapies markedly improve responses Combination of these regimens improves poor prognosis of high-risk cytogenic abnormalities (CA) in elderly MM patients Mateos et al, Blood 114, Abstract 3, 2009

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29 Bortezomib/Melphalan/Prednisone/Thalidomide – Bortezomib/Thalidomide Palumbo et al, Blood 114, Abstract 128, 2009 Study Objective: Compare VMPT with a maintenance regimen including bortezomib and thalidomide to VMP without a maintenance regimen Study Design: Prospective, randomized Both regimens amended to nine 5-week cycles Bortezomib modified to weekly administration (days 1,8,15,22) A Phase 3 Study of VMPT Followed by Maintenance With Bortezomib and Thalidomide for Initial Treatment of Elderly Multiple Myeloma Patients

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30 Conclusions from VMPT – VT vs. VMP VMPT followed by VT was superior to VMP for response rates and PFS. The weekly infusion of bortezomib significantly reduced the incidence of grade 3-4 peripheral neuropathy From 18% to 4% (p=0.0002) in VMPT arm From 13% to 2% (p=0.0003) in VMP arm This is the first report showing the superiority of a 4-drug regimen followed by maintenance compared to standard therapy (VMP) Palumbo et al, Blood 114, Abstract 128, 2009

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31 Melphalan/Prednisone vs. Melphalan/Prednisone/Thalidomide Kapoor et al, Blood 114, Abstract 615, 2009 MP vs. MPT as Initial Therapy for Previously Untreated Elderly and/or Transplant-Ineligible Patients With Multiple Myeloma: A Meta-Analysis of Randomized Controlled Trials Study objective: Systemic review of randomized controlled trials to compare efficacy of MP with MP+T Clinical endpoints are response rate (RR), progression-free survival (PFS), and overall survival (OS) Study design: Comprehensive search of database to identify randomized controlled trials Meta-analysis by pooling results on clinical endpoints

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32 Conclusions from MP vs. MPT Five prospective randomized controlled trials were identified (1571 patients data analyzed) The data indicated that MPT was better than MP in achieving at least a partial response. The pooled hazards ratios for PFS and OS were in favor of MPT Analyses suggest that MPT is superior to MP in terms of response and survival Kapoor et al, Blood 114, Abstract 615, 2009

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33 MP vs. MPR vs. MPR – R Palumbo et al, Blood 114, Abstract 613, 2009 Study objective: In previous studies lenalidomide was effective in relapsed/refractory MM Compare safety and efficacy of MPR in NDMM patients Study design: A Phase 3 Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Melphalan and Prednisone (MPR) in Elderly Patients With NDMM

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34 Conclusions From MP vs. MPR vs. MPR – R MPR – R regimen reduced risk of progression by 50% vs. MP alone MPR followed by lenalidomide maintenance is a new therapeutic option This regimen can be considered a new standard for elderly patients Palumbo et al, Blood 114, Abstract 613, 2009

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35 Lenalidomide After ASCT Attal et al, Blood 114, Abstract 529, 2009 First Analysis of a Phase 3 Study of the Intergroupe Francophone Du Myelome (IFM 2005 02) Study objective: Controlling the residual disease after high-dose therapy Neuropathy a major limiting factor in previous study Lenalidomide evaluated (has lower neurological toxicity) Study design: Prospective, randomized, placebo-controlled 1st line ASCT less than 6 months before enrollment Consolidation with lenalidomide, 25 mg/day, po, 21 days/month, 2 months Maintenance until relapse Lenalidomide, 10-15 mg/day

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36 2-month consolidation with lenalidomide: 80% of patients were able to receive the planned 2 cycles of consolidation Significantly improved the sCR/CR rate Conclusions From Lenalidomide After ASCT Attal et al, Blood 114, Abstract 529, 2009

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37 Melphalan/Prednisone/Lenalidomide vs. High-Dose Melphalan MPR vs. Melphalan (200 mg/m2) and Autologous Transplantation in Newly Diagnosed Myeloma Patients: An Interim Analysis Palumbo et al, Blood 114, Abstract 350, 2009 Study objective: To compare melphalan/prednisone/lenalidomide (MPR) with tandem melphalan (200 mg/m2) in patients younger than 65 years Study design: Induction: four 28-day cycles Lenalidomide 25 mg days 1-21 Low-dose dexamethasone 40 mg days 1,8,15,22 Consolidation: MPR arm: six 28-days cycles Melphalan 0.18 mg/kg days 1-4 Prednisone 2 mg/kg days 1-4 Lenalidomide 10 mg days 1-21 Melphalan arm: tandem melphalan 200 mg/m2 with stem cell support

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38 Conclusions From MPR vs. MEL200 Rd is an effective and safe induction regimen Both MPR and MEL200 improved the quality of response. At one-year follow-up, PFS and OS are similar in both groups. Longer follow-up is needed Palumbo et al, Blood 114, Abstract 350, 2009

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39 Lenalidomide/Dexamethasone in Smoldering Myeloma Study objective: To investigate whether early treatment prolongs the time to progression (TTP) in sMM patients at high risk Study design: Multicenter, randomized, open-label High-risk population defined by plasma cells ≥10% and M-component ≥3 g/dL Len/dex arm, nine 4-week cycles: Lenalidomide: 25 mg/daily, days 1-21 Dexamethasone: 20 mg/daily, days 1-4 and 12-15 (total dose 160 mg) Maintenance with lenalidomide, 10 mg on days 1-21 every 2 months until progression Phase 3 Trial of Lenalidomide/Dexamethasone vs. Therapeutic Abstention in Smoldering Multiple Myeloma (sMM) at High Risk of Progression to Symptomatic MM Mateos et al, Blood 114, Abstract 614, 2009

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40 In sMM patients, lack of treatment is associated with early progression (17.5 months) with bone disease Lenalidomide/dexamethasone treatment prolonged TTP and induced CRs with a manageable and acceptable toxicity profile Conclusions From Lenalidomide/Dexamethasone in Smoldering Myeloma Mateos et al, Blood 114, Abstract 614, 2009

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41 Emerging New Treatments in Early Development ASCO 2009; Kumar et al, Blood 114, Abstract 127, 2009; Lonial et al, Blood 114, Abstract 432, 2009; Richardson et al, Blood 114, Abstract 301, 2009; Siegel et al, Blood 114, Abstract 303, 2009; Wang et al, Blood 114, Abstract 302, 2009; Niesvizky et al, Blood 114, Abstract 304, 2009 EVOLUTION phase 2 study Novel 3- and 4-drug combinations: VDR, VDC, VDCR Exploring the combination of bortezomib and dexamethasone with lenalidomide and cyclophosphamide in NDMM patients Development of a novel proteosome inhibitor, carfilzomib Appears to work in patients that are resistant to bortezomib Prior therapy with bortezomib doesn’t preclude a good response Minimal neuropathy and myelosuppression Development of pomalidomide, an immunomodulatory drug Evidence of efficacy in heavily pretreated patients with relapsed disease Acceptable safety profile Development of elotuzumab, a monoclonal antibody against a glycoprotein that is highly and uniformly expressed in MM Manageable toxicity profile in combinations with other agents Promising preliminary efficacy data

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42 Two new clinical paradigms are emerging: Control option Careful use of drugs, using agents sequentially Cure option Aggressive treatment Future Direction of Combinations & Protocols With Novel Therapies ASCO 2009; ASH 2009 Treatment of smoldering MM patients provided first evidence of efficacy in preventing progression. Evolving role of the new drug combinations for transplant-eligible and -ineligible patients New 4-drug aggressive regimen (VMPT) New strategy for bortezomib: weekly dose with much better tolerability

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43 Conclusions Novel combination therapies exhibit great potential in improving RR, TTP, PFS, and OS outcomes Randomized clinical trials are underway to compare which of these novel combinations will offer patients better OS balanced with a good quality of life

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44 Joseph Tariman, PhC, MN, APRN, BC University of Washington Seattle, WA The NLB’s Long-Term Survivorship Care Plan

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45 Why Survivorship Care for Multiple Myeloma? Long-term care management offers the opportunity to enhance the patient’s treatment outcome and quality of life Increased survival leads to the need for new approaches to quality survivorship care

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46 Brenner et al, Blood, 2008 Multiple Myeloma Patients Are Living Longer Post Diagnosis

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47 Kumar et al, Blood, 2008 The Kaplan-Meier curves for overall survival from diagnosis: Groups are divided based on the time of diagnosis: After 12-31-1996 On or before 12-31-1996 Grouped into 6-year intervals based on the date of diagnosis Reprinted by permission from the American Society of Hematology Individuals Diagnosed With MM Are Living Longer

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48 The Kaplan-Meier curves for overall survival from the time of post-transplantation relapse: Grouped into 2-year intervals based on the date of relapse Grouped by whether the patients were treated with one or more newer drugs Thalidomide Lenalidomide Bortezomib Kumar et al, Blood, 2008 Reprinted with permission from the American Society of Hematology Post-Transplantation Relapsed Patients Are Also Living Longer

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49 Assessment of Early Overall Survival 1-year survival steadily improving R/low-dexamethasone 96% Total therapy 2 92% VMP (VISTA) 90% R/dexamethasone 88% ASCT 88% MPT 87% Thalidomide/dexamethasone 80–83% Barlogie et al. N Engl J Med 2006; Facon et al. Lancet 2007; Palumbo et al, Lancet 2006; Rajkumar et al J Clin Oncol 2006; Rajkumar et al J Clin Oncol 2008; Rajkumar et al ASH 2008; San Miguel et al N Engl J Med 2008; Increased survival leads to the need for new approaches to quality survivorship care

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50 Nurse-Centric Model of Survivorship Care* * Developed by ScienceFirst, LLC; All Rights Reserved (www.science-first.com)

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51 International Myeloma Foundation’s Nurse Leadership Board A partnership with multiple myeloma nurses to gain insights into their unmet needs and to address them and those of their patients by accomplishing the following objectives: Provide insights into the needs of myeloma nurses and their patients Identify and implement key nurse and patient education programs Facilitate information flow between the IMF, oncology nursing organizations, and patients

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52 Opportunity to leverage the NLB’s experience by identifying relevant side effects and developing a Long-Term Survivorship Care Plan for Multiple Myeloma Meeting the Unmet Need Survivorship Care Plan will enhance the patient’s treatment outcome and quality of life. Survivorship Care Plan will need to be updated as new therapies emerge

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53 First Step: Consensus Guidelines for Management of Acute Side Effects NLB determined the 5 most common emergent side effects requiring clinical “Consensus Statement” development. Peripheral neuropathy DVT and PE Myelosuppression GI effects Steroid effects IMF-NLB ‘Consensus Statements’ supplemCJON June 2008 Managing the Side Effects of Novel Agents for Multiple Myeloma: Guidelines and Patient Education Sheets – NLB 2008 Clinical Journal of Oncology Nursing – Supplement to Vol. 12 (3)

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54 NLB Dissemination 2010 NLB Speaker Programs: “Consensus on Care” 10 programs in 10 cities Speakers at IMF Patient & Family Seminars Speakers at IMF Regional Community Workshops NLB poster at the XII International Myeloma Workshop NLB blogged at the XII International Myeloma Workshop Articles appear in Myeloma Today Hold informational conference calls with support groups Participate as faculty at the annual ONS meeting Participate in advocacy initiative – Hill visits and in the communities Run patient advisory boards

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55 Next Step: Developing a Long-Term Survivorship Care Plan Evidence-based data for 5 major long-term side-effect issues and their management: creation of clinical practice-based consensus documents Outcome: Survivorship Care Plan and Manuscript Functional Mobility Sexuality & Sexual Dysfunction Bone Health & Bone Disease Renal Complications Health Maintenance

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56 56 Defining Cancer Survivorship The process of living with, through, and beyond cancer. By this definition, cancer survivorship begins at diagnosis. It includes people who continue to have treatment either to reduce risk of recurrence or to manage chronic disease (ASCO, 2009)

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57 57 Comparisons of Patient and Physician Expectations for Cancer Survivorship Care Investigators from the Harvard School of Public Health, Dana-Farber Cancer Institute, and the Institute of Clinical Evaluative Sciences (Toronto) conducted a study to compare expectations regarding survivorship care among PCPs, oncologists, and patients. The results demonstrated a lack of agreement among these constituents with respect to their roles in ongoing survivor care The discordance was particularly high between patients and their oncologists. The underlying causes for the discrepancies were unclear Cheung et al, JCO 2009

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58 Barriers to Cancer Survivor Care +

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59 Challenges to Survivorship Care As lives are extended, so too are the risks of developing late or delayed effects Leigh, Cancer Survivorship: A Nursing Perspective, in Cancer Survivorship Today and Tomorrow, 2007 Major question: Who will be responsible for Monitoring patient’s health? Assisting in recovery? Making referrals? Paying for continued care?

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60 60 Cancer Survivorship: From Individual to Experience Defined as A time frame A stage or phase An outcome Must take into account Maintenance therapy Incurable but treatable cancers Regimen changes Recurrences Secondary malignancies Late effects of treatments General health maintenance

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61 61 Cancer Survivorship Care: “Why Is it Important?” Cancer survivorship has tripled to 10 million over the past 30 yrs in the US Impacting cost on healthcare system High elderly population (~6 million) One in nine adult cancer survivors under age 65 is uninsured Lack of guidelines for survivors Most will return to work, but one in 5 will have cancer-related limitations up to 5 yrs later Shulman & Ganz ASCO Survivorship Models 2008 Institute of Medicine (IOM) Findings

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62 62 IOM Findings: Survivorship Care (cont’d) IOM Recommendation: “All patients completing Rx should receive a comprehensive treatment summary & care plan.” Shulman & Ganz ASCO Survivorship Models 2008

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63 63 IOM Recommendations for Quality Healthcare in America Care based on continuous healing relationships Customized care Patient as source of control Shared knowledge and information Evidence-based decision making Safety as a system property Transparency Anticipation of needs Continuous decrease in waste Cooperation

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64 Reasons for a Survivorship Care Plan Summarize treatment Communicate late effects of disease and treatment Promote interactions between patients and healthcare providers Promote a healthy lifestyle Prevent early recurrence Reduce risk of co-morbid conditions Shulman & Ganz ASCO Survivorship Models 2008

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65 What Is a Survivorship Care Plan? Implementing Cancer Survivorship Care Planning http://www.nap.edu/catalog/11739.html It aims to Promote a healthy lifestyle Prevent recurrence of cancer Reduce risk of co-morbid conditions Ensure adherence to follow-up recommendations It needs to Be prospective Identify known and potential long-term effects A document Summarizes what transpired during cancer treatment Gives recommendations for follow-up care

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66 Key Elements for Cancer Survivorship Care Planning Shulman & Ganz ASCO Survivorship Models 2008

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67 Creation of a Long-Term Survivorship Care Plan in Multiple Myeloma The plan will Prevent and control Adverse cancer diagnosis Treatment-related outcomes Late effects of treatment Second cancers Suboptimal quality of life Provide a knowledge base for follow-up care and surveillance Optimize health during cancer treatment Co-morbid conditions affect Treatment options Survival Late side effects

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68 Long-Term Care Plan: Recommendations for Clinicians Excerpt of the Recommendations for Clinicians: Renal Health IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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69 Long-Term Care Plan: Patient Tear-Out Tool Excerpt of the Patient Tear-Out Tool: Renal Health IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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70 Essentials of Survivorship Care Prevention and detection of new cancers and recurrence Intervention for consequences of cancer and its treatment (eg, diabetes) Coordination between specialists and primary care providers

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71 Develop recommendations for schedules of evaluations and evidenced-based interventions: Enable clinicians and patients to optimize therapy by preventing or adequately treating co-morbid conditions. Goals of NLB Survivorship Care Plan

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72 NLB will disseminate this information to those within the community who can affect the most change: Patients Caregivers Healthcare providers Goals of NLB Survivorship Care Plan (cont’d)

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73 Survivorship Care Continuum Individuals with chronic or intermittent disease may receive ongoing treatment for their disease, but benefit from survivorship care as they live with their disease Prevention Diagnosis Initial treatment Continuing care Maintenance Follow-up Recurrence Progressive disease Palliative care Survivorship isn’t a stage!!!! It is a continuum from diagnosis through the patient’s life.

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74 Teresa Miceli, RN, BSN, OCN® Mayo Clinic – Rochester Rochester, MN Impact of Myeloma Disease, Treatments, Long-Term Effects, and Patient-Specific Characteristics on: Bone Disease and Bone Health Functional Mobility and Safety

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75 Caused by defects in the balance between bone formation and resorption Osteoblast inhibition and activation of osteoclasts 80% to 90% of patients will have osteoporotic and osteolytic bone lesions at some time during the course of their disease Bone Disease in Multiple Myeloma http://www.wheelessonline.com/ortho/multiple_myeloma; http://www.uams.edu/radiology/info/clinical/pet/images.asp Bone destruction is a hallmark of multiple myeloma. Osteolysis often present in multiple myeloma bone marrow biopsy

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76 Bone disease is the major cause of morbidity and mortality, leading to Pathological fractures Spinal cord compression and neurological changes Severe pain (~60%) Hypercalcemia (30%) Prognostic implications Increased number of lesions correlates with poorer prognosis Co-morbid sequelae Bone Disease in Multiple Myeloma (cont’d) http://www.wheelessonline.com/ortho/multiple_myeloma Skeletal events may progress despite continued treatment

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77 Functional mobility Pain Limits normal activities of daily living Impact on employability Neurological changes due to vertebral compression fractures Paralysis Chronic paresthesia Psychological impact Depression, sexual dysfunction, body image Quality of life Consequences of Bone Disease IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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78 Bone Health and Bone Disease: Summary of Treatments Management of multiple myeloma-related bone disease involves treatment of the underlying disease! Roodman, Am S Hem Ed Prog 2008; Yeh & Berenson, Clin Cancer Res 2006; Fitch & Maxwell, Oncol Nurs Forum 2008; Berenson et al, JCO 2002; Pennisi et al, Am J Hematol 2009; Cady et al, J Am Coll Surg 2005; Faiman et al, Clin J Onc Nurs 2008

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79 Bone Health and Bone Disease: Position Statement Improvement in OS makes effective skeletal care critically important in MM patients Oncology healthcare providers play a key role. Monitoring for bone disease and related sequelae Maintaining adequate bone health Nurses need to provide interventions that promote bone health maintenance to improve mobility and enhance quality of life NLB to enact a plan of care that encompasses the needs of MM survivors along their care spectrum IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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80 Assess and treat bone disease and bone-related sequelae Monitor regularly for bone pain and bone-related complications Assess impact of MM therapeutics on bone health Include risk factors present due to co-morbid conditions to optimize treatment plan Institute interventions and management strategies based on the patients disease state Active disease Remission Strategic Recommendations Osteoporosis and osteolytic bone lesions have clinical implications and impact quality of life. IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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81 Evidence-Based Recommendations Healthcare Provider Tool Patient Education Tool Mobility and exercise Dietary recommendations and supplements Regular assessment of bone disease and bone health (lab and imaging) Radiation treatment Surgical interventions and post-surgery care Use of bisphosphonates Effective pain management IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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82 Functional Mobility and Safety in Multiple Myeloma Multiple myeloma occurs more commonly in the elderly population Bone disease is a major component of multiple myeloma Inherent to this and other risk factors are issues of mobility and safety. Up to 1/3 of older adults fall every year In myeloma, falls often lead to fractures Roodman, Leukemia 2008; Roodman, Hem Am Soc Hematol Educ Program 2008; Melton et al, J Bone Miner Res 2004

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83 Risk Factors Affecting Functional Mobility in Multiple Myeloma Patients Factors Contributing to High Risk of Falls (ROF): Gantz et al, J Am Med Assoc 2007

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84 Side Effects’ Impact on Functional Mobility and Safety CJON June 2008, 12(3) suppl.

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85 Mobility issues and ROF pose serious challenges to MM patients Oncology healthcare providers need to help patients to achieve improvements in functional ability, strength, and balance to reduce ROF and fall-related injuries NLB to enact a plan of care that includes assessment, evaluation, intervention, and education for reducing symptoms and enhancing functional capacity NLB recommendations to advocate health maintenance as an integral part in preserving mobility Functional Mobility and Safety: Position Statement IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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86 Strategic Recommendations Assess level of activity and factors affecting mobility Routinely assess for factors that increase ROF Institute interventions and management strategies: Safe mobility and physical activity programs tailored to the needs of each patient Incorporate nutrition Functional mobility and ROF have clinical implications, and impact quality of life and safety. IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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87 Evidence-Based Recommendations Healthcare Provider Tool Patient Education Tool Overall assessment (medications, lab, and diagnostic tests) Risk factor and falls risk assessment Planned physical activity Type of physical activity guidelines Regular exercise regimen/program Dietary recommendations and nutrition IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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88 Tiffany Richards, MS, ANP, AOCNP® MD Anderson Cancer Center Houston, TX Impact of Myeloma Disease, Treatments, Long-Term Effects, and Patient-Specific Characteristics on: Renal Complications Sexuality and Sexual Dysfunction

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89 Renal Complications and Disease in Multiple Myeloma Kidney dysfunction is one of the common clinical features of symptomatic MM. Between 20% and 60% of MM patients present with renal insufficiency or renal failure at diagnosis or throughout their disease. It may negatively affect overall survival and quality of life. Tariman and Faiman, in Cancer Nursing Principles and Practice, 2010; Blade et al, Arch Intern Med, 1998

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90 Manifestations and Pathogenesis of Kidney Failure Manifestations of renal disease Elevated serum creatinine level Anemia and fatigue Fluid and electrolyte imbalances Renal failure requiring: Dialysis Medication modification Dietary precautions Pathogenesis and factors impacting renal functions Hypercalcemia Dehydration Medications Light chain infiltration Co-morbid conditions (diabetes, etc) Lokhorst, in Mehta & Singhal, eds. Myeloma 2002; Dimopoulos et al, Leukemia 2008; Tariman et al, Cancer Nurs Princ Pract 2010 (in press); Rajkumar & Kyle, Mayo Clin Proc 2005; NKF, Am J Kidney Dis 2002

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91 Risk Factors Impacting Renal Functions in Multiple Myeloma Patients Kidney disease exacerbates progression of multiple myeloma Failure to maintain proper levels of calcium and phosphorus in blood Limited treatment options due to kidney complications Hereditary and social factors Age >60 years Racial or ethnic status Family history of renal disease Co-morbidities Diabetes Cardiovascular disease Hypertension Treatment side effects Infections Anemia IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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92 Renal Complications and Disease: Summary of Novel Multiple Myeloma Treatment Effects Celgene Corporation, Revlimid (lenalidomide) [package insert], 2006; Chanan-Khan et al, Blood 2007

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93 Renal insufficiency and failure is one of the common clinical features of symptomatic multiple myeloma at presentation or throughout the disease Oncology nurses can identify patients at risk for kidney damage and need to institute therapeutic and preventive interventions NLB to enact a plan of care that addresses therapeutic and diagnostic interventions for the management of MM in the context of poor renal function Longo & Anderson, K. Plasma cell disorders. In Harrison's principle of internal medicine 2005 Renal Complications: Position Statement

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94 Strategic Recommendations Renal dysfunction and renal insufficiency are common clinical features in MM patients and have to be aggressively managed. Early identification of renal impairment Diagnosis and interventions throughout therapy Educational and preventive strategies Myeloma-specific drug therapies Alleviation or exacerbation of side effects Recommendations for long-term care Surveillance for chronic kidney disease IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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95 Evidence-Based Recommendations Healthcare Provider Tool Patient Education Tool Diagnosis of renal insufficiency Impact of MM therapies on renal function Additional risk factors and co-morbidities Attendant bone complications Newly diagnosed patients – transplant eligible and transplant ineligible Patients on dialysis Monitoring IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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96 Sexuality & Sexual Dysfunction Sexual desire disorder (decreased libido) Sexual arousal disorder Orgasm disorder Sexual pain disorder Sexual dysfunction (SD) is characterized by those psychological and physiological changes that negatively impact sexuality. SD is not part of the normal aging process!! It is a result of physical illness and environmental and/or psychological factors. DSM IV – Diagnostic & Statistical Manual of Mental Disorders Shabsigh and Rowland, J Sex Med, 4(5) 2007; Clayton and Ramamurthy, Adv Psychosom Med, 29 2007

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97 SD affects 43% of women and 31% of men in the United States SD is one of the more common enduring consequences of cancer treatment and one that is not often addressed 73% of women with hematological malignancies reported decreased libido, and 48% were dissatisfied with their sex life Publications regarding SD in cancer patients are limited. Co-morbidities impact sexual function Sexuality & Sexual Dysfunction: Unmet Need for Cancer Survivors Ganz & Greendale, J Natl Cancer Inst 2007; Tierny et al, Europ J Onc Nursing 2007

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98 The Impact of Myeloma Treatment on Sexuality Our knowledge of the effects of novel myeloma treatment on sexuality is very limited: Patients are reluctant to discuss the issue Sexuality assessments are not performed Murphy and O’Donnell, Haematologica, 92 (10), 2007

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99 Sexual Dysfunction: Communication Is Critical! Urgent need for open communication between physicians, nurses, and their patients Multiple well-established treatments for SD are available for male and female patients. Patients may be unable or unwilling to verbalize this as a side effect. This is often placed on the back burner, as treatment is most important. Ask your patients!! IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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100 Sexual Dysfunction: Assessing the Patient PLISSIT Assessment Model Routine assessment is a powerful tool in identifying and treating SD. Annon, The PLISSIT model: a proposed conceptual, 1976; Mick, Clin J Onc Nursing 2007

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101 Interventions for Erectile Dysfunction Aung et al, Am J Chin Med 2004; Bruner & Calvano, Nurs Clin North Am 2007

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102 Sexual dysfunction is a real issue in MM patients This condition is not fully discussed or addressed comprehensively Oncology nurses can play a key role in bringing this issue to the forefront with MM patients NLB to enact a plan of care that promotes dialogue regarding the causes of sexual dysfunction, and recommends assessment practices to address this condition Sexual Dysfunction: Position Statement IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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103 Strategic Recommendations Sexual dysfunction is a real issue and is not fully addressed in MM patients. Urgent need for open communications Physicians Nurses Patients Interventions Pharmacologic and non-pharmacologic Educational and psychosexual interventions IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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104 Evidence-Based Recommendations Healthcare Provider Tool Patient Education Tool Identify causative factors of sexual dysfunction Co-morbid conditions Secondary factors Tertiary factors Assess impact of MM treatment Evaluate sexual function (physical, lab) Effective communication Treatment of male and female sexual dysfunction IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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105 Impact of Myeloma Disease, Treatments, Long-Term Effects and Patient-Specific Characteristics on: Health Maintenance Elizabeth Bilotti, RN, MSN, APRN, BC The John Theurer Cancer Center at Hackensack University Medical Center Hackensack, NJ

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106 Optimizing Survival: Importance of Health Maintenance Myeloma patients are expected to live longer Good state of health provides the opportunity to improve survival by maintaining patients on appropriate therapy

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107 Impact of Novel Therapies on Survivorship Care Family/social problems Financial/insurance concerns Unexpected new long-term complications Second cancers Long-term maintenance for survivors: quality of life IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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108 Barriers to Health Maintenance Low awareness among clinicians and patients about the need to maintain overall wellness Lack of knowledge regarding existing guidelines Inadequate understanding about the role of co-morbidities to poor patient health Time constraints Skepticism about the value of maintaining good health Unhealthy lifestyle choices Uninformed decisions Lack of health maintenance recommendations that address the entire patient treatment spectrum (ie, diagnosis through therapy) IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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109 Overall health maintenance is vitally important to help MM patients toward improved survival MM patients are facing multiple risks: Illnesses usually experienced by general population of the same age Morbidities of MM itself Complications associated with MM treatments NLB to enact a plan of care that highlights health maintenance for: - Cardiovascular disease - Secondary malignancies - Endocrine disorders - Bone metabolism disorders - Sensory changes - Depression - Nutrition - Chemical dependency Longo & Anderson, K. (2005). Plasma cell disorders. In Harrison's principle of internal medicine (16th ed., pp. 656-662). New York: McGraw-Hill Health Maintenance: Position Statement

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110 Personalize screening recommendations for health promotion and disease prevention Disseminate the information to those who can effect the most change: Patients Families Healthcare professionals Strategic Recommendations Institute health maintenance as an integral part of the MM patient care continuum. IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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111 Major Risk Factors Affecting Health Maintenance Psychosocial Lifestyle choices Substance abuse Nutrition Activity Cognitive changes Depression “Chemo brain” effect Employability and access to healthcare Physical Dermatologic Skin cancer risk Altered immune system Immunizations Repeat hospitalizations Pain Anemia IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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112 Evidence-Based Recommendations Healthcare Provider Tool Patient Education Tool Current guidelines and their application for cancer patients Series of interventions offered to cancer patients at defined intervals depending on: Age Gender Risk factors Specific needs of multiple myeloma patients due to novel therapeutics Sources for recommendations Centers for Disease Control and Prevention (CDC) US Preventative Services Task Force American College of Physicians IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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113 Specific Screening Interventions: Examples IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation

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114 Closing Remarks

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115 Why a Survivorship Care Plan for Multiple Myeloma? Increased survival leads to the need for new approaches to quality survivorship care.

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116 Old Model Survivorship as a stage: Decreasing contact Brief check-ups May not recognize survivorship Busy clinics Time constraints Focus on acutely ill Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007 Emerging Model Survivorship as a process: Contact along the extended continuum of care Survival plan will be developed shortly after diagnosis Survivors and families will be supported medically, emotionally, financially. It is not just about IF and HOW LONG, but HOW WELL?? Shifting Paradigm for Survivorship Care: Nurse Role

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117 Nurse-Led Survivorship Care Nurses: Expert knowledge Close relationships with patients and families Understand psychosocial issues Recommend referral Work within a model of wellness promotion rather than disease management Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007

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118 Nurse-Led Survivorship Care (cont’d) Barriers: Shortage of trained oncology nurses, especially in outpatient settings Lack of coordinated care and communication among healthcare providers Insurance and reimbursement issues Lack of appreciation/understanding of the role of survivorship care with healthcare providers Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007

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119 National Coalition for Cancer Survivors (NCCS) “Imperatives” NCCS’s “Imperatives for Quality Cancer Care: Access, Advocacy, Action, and Accountability”: Nurses are major players Health promotion and wellness are critical in survivor clinics Continued need for supportive care Critical value of education and rehabilitation for symptoms: Fatigue, chronic pain, weight changes, decreased stamina NCCS. Imperatives for Quality Cancer Care: Access, Advocacy, Action, and Accountability, 1996

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120 Publication of the Survivorship Care Plan will be immeasurably valuable to the general nursing community involved in multiple myeloma patient care Communication and dissemination of the Survivorship Care Plan are important next steps Develop new educational materials/tools: - Patient related - Nurse related Focus of NLB Commitment

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121 Patient Education Tear-Out Tools General format and clinical utility: Side effect description Novel therapies that may be associated with the side effect Signs and symptoms Risk factors Healthcare provider recommendations NLB Consensus Statements, CJON June 2008

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122 ASCO Tools for Survivorship Care An important component of survivorship care is a patient’s treatment summary www.asco.org/treatmentsummary

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123 123 IMF NLB Vision for Survivorship Care Prevention Diagnosis Initial treatment Continuing care Maintenance Follow-up Recurrence Progressive disease Palliative care Survivorship care isn’t a stage!!!! It is a continuum from diagnosis through the patient’s life. Nurses are now empowered and enabled to implement this vision

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124 Educational Resources International Myeloma Foundation - IMF Myeloma Today Newsletter - (800) 452-CURE (2873) - www.myeloma.org Oncology Nursing Society - www.ons.org American Cancer Society National Cancer Institute

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125 International Myeloma Foundation Membership – more than 185,000 globally Scientific Advisory Board (72 world-recognized experts) Trained IMF Hotline Coordinators respond to more than 4,300 telephone calls and 3,600 e-mails each year. Multilingual Web site – in 2009 – tracking toward 70 million “hits” with a 97% repeat visitor rate The IMF distributes approximately 20,000 information packages (Info Packs) a year. These packages are sent to patients, caregivers, nurses, major cancer centers, clinics, and physician offices. Myeloma Minute Electronic informational e-mail Myeloma Manager – Personal Care Assistant A unique software solution engineered specifically for myeloma patients

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126 Acknowledgements   Elizabeth Bilotti Beth Faiman Teresa Miceli Tiffany Richards Joseph Tariman Oncology Nursing Society International Myeloma Foundation Medical Education Resources

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127 Question & Answer Session Faculty Panel