Treatment of Myeloma Bone Disease

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Treatment of Myeloma Bone Disease"

Transcription

1 Treatment of Myeloma Bone Disease James R. Berenson, MD Medical & Scientific Director Institute for Bone Cancer & Myeloma Research West Hollywood, CA

2 Clinical Consequences of Myeloma Bone Disease Pathological fractures Non-vertebral Vertebral compression Spinal cord compression/collapse Radiation therapy Surgery to bone Hypercalcemia Bone pain Use of analgesics Quality-of-life effects Survival

3 Prevalence of Skeletal Complications in 21 months among MM Patients Total Pathologic fracture Radiation to bone Hypercalcemia of malignancy Surgery to bone Spinal cord compression Patients With SREs, % 9-month data. Placebo arm of pamidronate randomized trial. Berenson JR et al. N Engl J Med. 1996;334: Berenson JR, et al. J Clin Oncol. 1998;16:

4 Clinical Consequences of Myeloma Bone Disease Pathological fractures Non-vertebral Vertebral compression Spinal cord compression/collapse Radiation therapy Surgery to bone Hypercalcemia Bone pain Use of analgesics Quality-of-life effects Survival

5 Kyphoplasty: A Minimally Invasive Fracture Reduction Procedure KyphX Introducer Tool Kit: Allows precise, minimally invasive access to the vertebral body. Provides working channel. KyphX IBT inflation: Reduces the fracture. Compacts the bone. May elevate endplates. KyphX IBT Removal: Leaves a defined cavity and trabecular dam that can be filled with an approved bone void filler of the physician s choice.

6 Kyphoplasty: Use in Myeloma Patients w/ Vertebral Compression Fractures 55 procedures in 18 patients Assess safety and efficacy using the Short Form Health Survey (SFHS) scoring system at pre, 1, 6, 12, 36, & 52 weeks Body pain, Physical function, Vitality, Social Function Results Levels: T6-L5 (majority (56%) from T11-L5) No major complications Improvement in SFHS assessments Dudeney et al. J Clin Oncol 2002

7 The CAFÉ Study A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-Surgical Fracture Management* in the Treatment of Cancer Patients with Painful Vertebral Body Compression Fractures *Allowed to have kyphoplasty 30 days later

8 Bisphosphonates in the Treatment of Myeloma Bone Disease: Randomized Studies Oral Etidronate* - Belch et al, J Clin Oncol 1991 Clodronate* - Lahtinen et al, Lancet 1992; McCloskey et al, Br J Haematol 1998 Pamidronate* Brincker et al, Br J Haematol 1998 Intravenous Pamidronate* Berenson et al, N Engl J Med 1996 Ibandronate* Menssen et al J Clin Oncol 2002 Zoledronic acid + Berenson et al, Cancer 2001; Rosen et al, The Cancer J 2001 * Placebo-controlled; + Pamidronate-controlled

9 Effect of Monthly Intravenous Pamidronate (90 mg) in Reducing Skeletal Events in Patients with Advanced Multiple Myeloma: A Phase III Trial Berenson JR, et al. N Engl J Med. 1996;334(8):

10 Zoledronic acid Zoledronic acid belongs to a new class of bisphosphonates 1,2 Heterocyclic, nitrogen-containing bisphosphonate composed of: A core bisphosphonate moiety An imidazole-ring side chain containing 2 critically positioned nitrogen atoms 2-3 logs more potent than pamidronate in preclinical studies 1,2 N N O HO P O OH P OH OH OH 1. Green J, et al. J Bone Miner Res Green J, et al. Pharmacol Toxicol

11 Zoledronic Acid in Myeloma and Breast Cancer Patients: Protocol 010 Trial Design 24-mo dosing regimen Pamidronate 90 mg every 3 to 4 wk/ 120-min infusion Zoledronic acid 4 mg and 8/4 mg every 3 to 4 wk/ 5-min amended to 15-min infusion Double-blind, double-dummy Study duration: 25 mo Patients received oral vitamin D 400 IU and calcium 500 mg

12 Breast Cancer and Multiple Myeloma Efficacy Summary Time to Multiple- Proportion first SRE Mean skeletal event analysis with SRE, % (median)* morbidity rate* hazard ratio* ZA** 4 mg Pam 90 mg P value *Hypercalcemia of malignancy is included as a skeletal-related event ** ZA- zoledronic acid Extension data

13 Multiple Myeloma Time to First Serum Creatinine Increase* Patients without increase, % Time, days n Hazard ratio P value ZOMETA 4 mg 15 min Pamidronate 90 mg-2 hr 84 ZOMETA 4 mg Pamidronate *Post 15-minute infusion amendment. Versus pamidronate infused over 2 hours After start of study drug.

14 How to Approach the Patient w/ Rises in Creatinine While on a Bisphosphonate (BP) Look for possible causes besides the BP The Cancer (myeloma, etc) Other co-morbid diseases (diabetes, hypertension, etc) Medications (NSAIDS, COX-2 inhibitors, statins, etc) Consider a kidney biopsy If the BP still may be the cause, hold the dose until the creatinine returns to baseline, & since the rate of infusion relates to kidney toxicity, SLOW the infusion down To 60 min for Zometa To > 4 hours for Aredia If problems persists, consider switching to the other IV BP If does not improve the problem, discontinue intravenously administered BPs and consider Fosamax orally

15 Osteonecrosis of the Jaw (ONJ) & Bisphosphonate (BP) Use Observed among CA patients receiving IV BPs (both pamidronate & zoledronic acid) Less frequent among pts receiving oral BPs Relationship to BPs unproven Treatment Good oral hygiene Peridex (chlorhexidine gluconate) rinse or Arestin (minocycline hydrochloride) periodontal pockets Intermittent antibiotics, antifungals or antivirals Keep surgery to a minimum No evidence that discontinuation of BP changes course of jaw problem Prophylaxis- Excellent oral hygiene

16 6 cases of ONJ Range of severity ONJ in Myeloma Patients- The IMBCR Experience 3 patients required intermittent antibiotics (Aredia + Zometa, Zometa only in 2) - remain on bisphosphonate treatment 1 patient recently diagnosed with minor temporary discomfort (Aredia only) - remains on treatment Largely resolved with clarithromycin PO 2 patients (Aredia + Zometa, Zometa only) discontinued bisphosphonate secondary to significant effect on mastication Status of myeloma 3 in long-term complete remission (auto-psct, VAD, thalidomide) 1 in near complete remission (on steroids) 2 with long-term indolent myeloma requiring no other therapy 1 patient with 40% reduction in M-protein for > 4 yr

17 IV Bisphosphonates for Patients With Myeloma Bone Disease Benefits vs Risks Benefits Risks Fractures Radiotherapy Bone pain ONJ? Renal (infrequent) Humeral fracture in a myeloma patient

18 Monoclonal Gammopathy of Undetermined Significance (MGUS) Pts w/ monoclonal immunoglobulin 3% of individuals over 70 years None of the clinical manifestations of myeloma, however Bone effects Increased osteoclastic activity High rate of bone loss Enhanced risk of fracture especially vertebral compression fracture* *Melton et al. J Bone Min Res 2004

19 Phase I/II Study of ZOMETA in MGUS Patients with MGUS and osteopenia/osteoporosis (n=80) (t-score < 1) ZOMETA 4 mg via 15-minute infusion at 0, 6 and 12 months Primary endpoint: Posterior-anterior spine BMD (0 & 13 mo) Secondary endpoints: Nondominant proximal femur BMD Skeletal radiographs in M-protein Progression

20 Myeloma Bone Disease Conclusions (I) Major clinical manifestation of MM High risk of pathological fractures Many patients receive radiotherapy Keep radiotherapy to a minimum Side effects Compromises bone marrow function Increasing recognition of the role of kyphoplasty to treat vertebral compression fractures

21 Myeloma Bone Disease Conclusions (II) IV zoledronic acid and pamidronate Reduce skeletal complications Pathologic fractures Radiation therapy Monitoring of kidney function (assess monthly serum creatinine) necessary although other causes more likely to cause renal dysfunction Osteonecrosis of the jaw may be associated with bisphosphonate use Good oral hygiene important to emphasize Avoid invasive dental procedures Potential anti-tumor effects being explored

Bone Disease in Myeloma

Bone Disease in Myeloma Bone Disease in Myeloma Washington, DC August 8, 2009 Brian G.M. Durie, M.D. Bone Disease in Myeloma Lytic Lesions Spike Bone Marrow Plasma Cells Collapse of Vertebrae Biology of Myeloma Vascular Cytokines

More information

Bone Disease in Myeloma. St. Petersburg, Russia September 16, 2009

Bone Disease in Myeloma. St. Petersburg, Russia September 16, 2009 Bone Disease in Myeloma St. Petersburg, Russia September 16, 2009 Bi Brian G.M. GMDurie, M.D. MD Bone Disease in Myeloma Lytic Lesions Spike Bone Marrow Plasma Cells Collapse of Vertebrae Biology of Myeloma

More information

The Role of Bisphosphonates in Multiple Myeloma: 2007 Update Clinical Practice Guideline

The Role of Bisphosphonates in Multiple Myeloma: 2007 Update Clinical Practice Guideline The Role of Bisphosphonates in Multiple Myeloma: 2007 Update Clinical Practice Guideline Introduction ASCO convened an Update Committee to review and update the 2002 recommendations for the role of bisphosphonates

More information

Bone Disease in Myeloma

Bone Disease in Myeloma Bone Disease in Myeloma Boston, Massachusetts Saturday, July 26, 2008 Brian G.M. Durie, M.D. Bone Disease in Myeloma Lytic Lesions Spike Bone Marrow Plasma Cells Collapse of Vertebrae Biology of Myeloma

More information

Understanding Bisphosphonate Therapy

Understanding Bisphosphonate Therapy Understanding Bisphosphonate Therapy International Myeloma Foundation 12650 Riverside Drive, Suite 206 North Hollywood, CA 91607 USA Telephone: 800-452-CURE (United States and Canada) 818-487-7455 FAX:

More information

Denosumab for the prevention of skeletalrelated events in adults with bone metastases from solid tumours

Denosumab for the prevention of skeletalrelated events in adults with bone metastases from solid tumours NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE National Institute for Health and Clinical Excellence Page 1 of 62 Final appraisal determination Denosumab for the prevention of skeletalrelated events

More information

M.T. Groot H.P. Sleeboom W. Gerritsen C.A. Uyl-de Groot. Cost of Breast Cancer, Metastatic to the Bone, in the Netherlands

M.T. Groot H.P. Sleeboom W. Gerritsen C.A. Uyl-de Groot. Cost of Breast Cancer, Metastatic to the Bone, in the Netherlands M.T. Groot H.P. Sleeboom W. Gerritsen C.A. Uyl-de Groot Cost of Breast Cancer, Metastatic to the Bone, in the Netherlands Cost of Breast Cancer, Metastatic to the Bone, in the Netherlands M.T. Groot 1

More information

BISPHOSPHONATE RELATED OSTEONECROSIS OF THE JAW (BRONJ) BISPHOSPHONATES AND WHAT HAPPENS TO BONE VINCENT E. DIFABIO, DDS, MS MEMBER OF THE COMMITTEE ON HEALTHCARE AND ADVOCACY FROM THE AMERICAN ASSOCIATION

More information

MULTIPLE MYELOMA Review & Update for Primary Care. Dr. Joseph Mignone 21st Century Oncology

MULTIPLE MYELOMA Review & Update for Primary Care. Dr. Joseph Mignone 21st Century Oncology MULTIPLE MYELOMA Review & Update for Primary Care Dr. Joseph Mignone 21st Century Oncology OVERVIEW Identify the diagnostic criteria for multiple myeloma Compare first & second line therapies, using data

More information

Bone lesions due to metastatic disease undermine

Bone lesions due to metastatic disease undermine Implications of Bone Metastases and the Benefits of Bone-Targeted Therapy Allan Lipton Several cancers, including those originating in the breast, prostate, and lung, exhibit a propensity to metastasize

More information

BONE HEALTH and. what you need to know

BONE HEALTH and. what you need to know BONE HEALTH and BREAST cancer: what you need to know Bone Health and Breast Cancer: What You Need To Know TABLE OF CONTENTS ABOUT BONE METASTASES...4 HOW DOES CANCER SPREAD & DESTROY THE BONE?...4 ABOUT

More information

Treating myeloma. Dr Rachel Hall Royal Bournemouth Hospital

Treating myeloma. Dr Rachel Hall Royal Bournemouth Hospital Treating myeloma Dr Rachel Hall Royal Bournemouth Hospital Treatment overview When to treat? Aim of treatment Which treatment? Monitoring response to treatment Prevention of complications What happens

More information

Bone Metastases in Advanced Prostate Cancer

Bone Metastases in Advanced Prostate Cancer Bone Metastases in Advanced Prostate Cancer a report by Fred Saad, MD, FRCS Centre Hospitalier de l Université de Montréal, Hôpital Notre-Dame, Montreal, Canada DOI: 1.17925/OHR.25...1v Fred Saad, MD,

More information

Medications for Prevention and Treatment of Osteoporosis

Medications for Prevention and Treatment of Osteoporosis 1 Medications for Prevention and Treatment of Osteoporosis Osteoporosis is a disease where the strength of bones is less than normal, making them more susceptible to fracture, or breaking, than normal

More information

What You Need to Know for Better Bone Health

What You Need to Know for Better Bone Health What You Need to Know for Better Bone Health A quick lesson about bones: Why healthy bones matter The healthier your bones The more active you can be Bone health has a major effect on your quality of life

More information

Osteoporosis Update. Jason Wu, DO Rheumatologist The Orthopedic Institute of New Jersey Atlantic Regional Osteopathic Convention 4/14/16

Osteoporosis Update. Jason Wu, DO Rheumatologist The Orthopedic Institute of New Jersey Atlantic Regional Osteopathic Convention 4/14/16 Osteoporosis Update Jason Wu, DO Rheumatologist The Orthopedic Institute of New Jersey Atlantic Regional Osteopathic Convention 4/14/16 Disclosures None Objectives Who to treat for Osteoporosis? Who gets

More information

Back Pain Update. Timothy McHenry, M.D. Orthopaedic Spine Surgery Greenville Health System

Back Pain Update. Timothy McHenry, M.D. Orthopaedic Spine Surgery Greenville Health System Back Pain Update Timothy McHenry, M.D. Orthopaedic Spine Surgery Greenville Health System Why would an orthopaedic surgeon read the New England Journal of Medicine? Medical Journal Impact Factor (2015)

More information

Oral Health Care Practitioners Perceptions of Bisphosphonate Related Osteochemonecrosis of the Jaws

Oral Health Care Practitioners Perceptions of Bisphosphonate Related Osteochemonecrosis of the Jaws Oral Health Care Practitioners Perceptions of Bisphosphonate Related Osteochemonecrosis of the Jaws Student: Kelly Cottrell Preceptor: T Dolan DDS, MPH Mentor: J Nieto MPH, MD, PhD Outline: Background

More information

Things You Don t Want to Miss in Multiple Myeloma

Things You Don t Want to Miss in Multiple Myeloma Things You Don t Want to Miss in Multiple Myeloma Sreenivasa Chandana, MD, PhD Attending Hematologist and Medical Oncologist West Michigan Cancer Center Assistant Professor, Western Michigan University

More information

THERAPEUTIC EFFICACY AND PHARMACOECONOMICS EVAULATION OF PAMIDRONATE VERSUS ZOLEDRONIC ACID IN MULTIPLE MYELOMA PATIENTS

THERAPEUTIC EFFICACY AND PHARMACOECONOMICS EVAULATION OF PAMIDRONATE VERSUS ZOLEDRONIC ACID IN MULTIPLE MYELOMA PATIENTS 438 J App Pharm 04(03): 438-452 (2011) Qasim et al., 2011 ORIGINAL ARTICLE THERAPEUTIC EFFICACY AND PHARMACOECONOMICS EVAULATION OF PAMIDRONATE VERSUS ZOLEDRONIC ACID IN MULTIPLE MYELOMA PATIENTS Saima

More information

Use of Bisphosphonates in Women with Breast Cancer

Use of Bisphosphonates in Women with Breast Cancer Evidence-based Series 1-11 Version 2.2002: TO BE UPDATED Use of Bisphosphonates in Women with Breast Cancer Members of the Breast Cancer Disease Site Group A Quality Initiative of the Program in Evidence-based

More information

Bisphosphonates for advanced breast cancer

Bisphosphonates for advanced breast cancer Bisphosphonates for advanced breast cancer a systematic review September 2010 Funded by the National Breast Cancer Foundation Bisphosphonates for advanced breast cancer: a systematic review was developed

More information

A Canadian Perspective on the Use of Bisphosphonates in the Clinical Management of Multiple Myeloma

A Canadian Perspective on the Use of Bisphosphonates in the Clinical Management of Multiple Myeloma A Canadian Perspective on the Use of Bisphosphonates in the Clinical Management of Multiple Myeloma Donna Reece, MD, FRCP(C); 1 Michael Sebag, MD, PhD, FRCP(C); 2 Darrell White, MD, FRCP(C); 3 Kevin Song,

More information

Osteoporosis Medicines and Jaw Problems

Osteoporosis Medicines and Jaw Problems Osteoporosis Medicines and Jaw Problems J. Michael Digney, D.D.S. Osteoporosis is a condition that affects over 10 million patients in this country, with the majority of those being post-menopausal women.

More information

Role of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases

Role of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases Role of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases R. Shraddha, P.N. Pandit Radium Institute, Patna Medical College and Hospital, Patna, India Abstract NHL is a highly

More information

BISPHOSPHONATES AHFS 92:00

BISPHOSPHONATES AHFS 92:00 BISPHOSPHONATES AHFS 92:00 Indications: Hypercalcemia of malignancy, Paget s disease, prevention/treatment of osteoporosis, prophylactic use to reduce the incidence of skeletal-related events in patients

More information

Lakeside Family Physicians & Lakeside Primary Care Patient Centered Medical Home Program Bone Densitometry Disease Management Pathway

Lakeside Family Physicians & Lakeside Primary Care Patient Centered Medical Home Program Bone Densitometry Disease Management Pathway Lakeside Family Physicians & Lakeside Primary Care Patient Centered Medical Home Program Bone Densitometry Disease Management Pathway PROTOCOL FOR PATIENTS WITH ABNORMAL LAB AND X-RAY VALUES Patients newly

More information

Appendix 11: Expert Panel Recommendation for the Prevention, Diagnosis and Treatment of Osteonecrosis of the Jaw

Appendix 11: Expert Panel Recommendation for the Prevention, Diagnosis and Treatment of Osteonecrosis of the Jaw Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover, NJ 07936 Appendix 11: Expert Panel Recommendation for the Prevention, Diagnosis and Treatment of Osteonecrosis of the Jaw and Aredia (pamidronate

More information

Radiotherapy in Plasmacytoma and Myeloma. David Cutter Multiple Myeloma NSSG Annual Meeting 14 th September 2015

Radiotherapy in Plasmacytoma and Myeloma. David Cutter Multiple Myeloma NSSG Annual Meeting 14 th September 2015 Radiotherapy in Plasmacytoma and Myeloma David Cutter Multiple Myeloma NSSG Annual Meeting 14 th September 2015 Contents Indications for radiotherapy: Palliation in Multiple Myeloma Solitary Bone Plasmacytoma

More information

Background. t 1/2 of 3.7 4.7 days allows once-daily dosing (1.5 mg) with consistent serum concentration 2,3 No interaction with CYP3A4 inhibitors 4

Background. t 1/2 of 3.7 4.7 days allows once-daily dosing (1.5 mg) with consistent serum concentration 2,3 No interaction with CYP3A4 inhibitors 4 Abstract No. 4501 Tivozanib versus sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma: Results from a Phase III randomized, open-label, multicenter trial R. Motzer, D.

More information

Drug treatments to protect your bones

Drug treatments to protect your bones Drug treatments to protect your bones This information is an extract from the booklet, Bone health. You may find the full booklet helpful. We can send you a copy free see page 5. Contents Bisphosphonates

More information

Peninsula Dental Social Enterprise (PDSE)

Peninsula Dental Social Enterprise (PDSE) Peninsula Dental Social Enterprise (PDSE) Surgical Management of Patients on Bisphosphonates Version 2.0 Date approved: December 2014 Approved by: The Board Review due: December 2015 Page 1 of 10 Clinical

More information

Thomas de los Reyes PGY 1 Department of Urologic Sciences University of British Columbia. Meet Mr. S

Thomas de los Reyes PGY 1 Department of Urologic Sciences University of British Columbia. Meet Mr. S Thomas de los Reyes PGY 1 Department of Urologic Sciences University of British Columbia Meet Mr. S 74 M admitted for back pain X-ray: sclerotic lesions along spine PSA 800 Nuclear Medicine Bone Scan 1

More information

PROTOCOL FOR PATIENTS WITH ABNORMAL LAB AND X-RAY VALUES

PROTOCOL FOR PATIENTS WITH ABNORMAL LAB AND X-RAY VALUES PROTOCOL FOR PATIENTS WITH ABNORMAL LAB AND X-RAY VALUES Patients newly diagnosed as osteopenic or osteoporotic on a radiology report or patients receiving abnormal lab values on the following lab tests

More information

Plasma cell dyscrasias Mark Drayson

Plasma cell dyscrasias Mark Drayson Plasma cell dyscrasias Mark Drayson Mortality statistics for England and Wales. Deaths attributed to multiple myeloma from 1988-1997 by age cohort as a percentage of total (21,257) deaths Deaths in age

More information

The Bisphosphonates: analogs of Pyrophosphate

The Bisphosphonates: analogs of Pyrophosphate Bisphosphonates The Bisphosphonates: analogs of Pyrophosphate Alendronate (Fosamax ) Clodronate (Bonefos ) Etidronate (Didrocal ) Ibandronate (Boniva ) Pamidronate (Aredia ) Risedronate (Actonel ) Tiludronate

More information

Clinical Management Guideline Management of locally advanced or recurrent Renal cell carcinoma. Protocol for Planning and Treatment

Clinical Management Guideline Management of locally advanced or recurrent Renal cell carcinoma. Protocol for Planning and Treatment Protocol for Planning and Treatment The process to be followed in the management of: LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA Patient information given at each stage following agreed information

More information

Treating Osteoporosis WITH BISPHOSPHONATES

Treating Osteoporosis WITH BISPHOSPHONATES Treating Osteoporosis WITH BISPHOSPHONATES Who is SIGMA? SIGMA is the Canadian Menopause Society. We are professionals specialized in different areas of post-menopausal women s health care, including family

More information

Multiple Myeloma s Impact on Bones

Multiple Myeloma s Impact on Bones A Report about Multiple Myeloma s Impact on Bones BONE HEALTH IN FOCUS The significance of bone health in patients with Multiple myeloma Today s patient with cancer faces a daunting amount of information.

More information

Cancer Related Issues: Bone Metastases

Cancer Related Issues: Bone Metastases Cancer Related Issues: Bone Metastases Bronwyn Long, RN, DNP, ACHPN, AOCNS Updated from Hawkins, R. Cancer Related Issues: Bone Metastasis. Pittsburgh, PA: Hospice and Palliative Nurses Association; 2010:

More information

Osteoporosis and Vertebral Compression (Spinal) Fractures Fact Sheet

Osteoporosis and Vertebral Compression (Spinal) Fractures Fact Sheet Osteoporosis and Vertebral Compression (Spinal) Fractures Fact Sheet About Osteoporosis Osteoporosis is estimated to affect 200 million women worldwide. 1 Worldwide, osteoporosis causes more than nine

More information

NATIONAL CANCER INSTITUTE. Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

NATIONAL CANCER INSTITUTE. Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma NATIONAL CANCER INSTITUTE Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma Basic Trial Information Phase Type Status Age Sponsor Protocol IDs Phase

More information

Frontier AIDS Education and Training Center

Frontier AIDS Education and Training Center Frontier AIDS Education and Training Center Vitamin D and HIV Subbulaxmi Trikudanathan, MD, MRCP, MMSc Division of Endocrinology, Metabolism and Nutrition University of Washington Medical Center Presentation

More information

Kanıt: Klinik çalışmalarda ZYTIGA

Kanıt: Klinik çalışmalarda ZYTIGA mkdpk de Sonunda Gerçek İlerleme! Kanıt: Klinik çalışmalarda ZYTIGA Dr. Sevil Bavbek 5. Türk Tıbbi Onkoloji Kongresi Mart 214, Antalya Endocrine therapies Adrenals Testis Abiraterone Orteronel Androgen

More information

SUMMARY OF THE RISK MANAGEMENT PLAN (by medicinal product)

SUMMARY OF THE RISK MANAGEMENT PLAN (by medicinal product) PART VI SUMMARY OF THE RISK MANAGEMENT PLAN (by medicinal product) Format and content of the summary of the RMP The summary of the RMP part VI contains information based on RMP modules SI, SVIII and RMP

More information

Multiple Myeloma Workshop- Tandem 2014

Multiple Myeloma Workshop- Tandem 2014 Multiple Myeloma Workshop- Tandem 2014 1) Review of Plasma Cell Disorders Asymptomatic (smoldering) myeloma M-protein in serum at myeloma levels (>3g/dL); and/or 10% or more clonal plasma cells in bone

More information

Falls and Fracture Risk assessment and management

Falls and Fracture Risk assessment and management Falls and Fracture Risk assessment and management Disclosures: Although various guidelines and studies were reviewed, this represents my own personal bias and conclusions. What do we know? 1) Fractures

More information

Boning Up On Osteoporosis

Boning Up On Osteoporosis Boning Up On Osteoporosis Nicholas J. Avallone,, M.D. Orthopedic Surgeon Sports Medicine Specialist Conflicts of Interest I have no relationships with any company listed in this talk. Resources National

More information

Recommendations for Care of the Osteoporotic Fracture Patient to. Reduce the Risk of Future Fracture

Recommendations for Care of the Osteoporotic Fracture Patient to. Reduce the Risk of Future Fracture Recommendations for Care of the Osteoporotic Fracture Patient to Reduce the Risk of Future Fracture Developed by the World Orthopedic Osteoporosis Organization (WOOO) Olof Johnell 1, John Kaufman 2, Steven

More information

Diagnosis of Monoclonal Gammopathies

Diagnosis of Monoclonal Gammopathies Diagnosis of Monoclonal Gammopathies Julio C. Delgado, MD, MS Assistant Professor of Pathology Director Immunology Laboratory, ARUP Laboratories Associate Director H&I Laboratory, University of Utah Health

More information

UNDERSTANDING MULTIPLE MYELOMA AND LABORATORY VALUES Benjamin Parsons, DO bmparson@gundersenhealth.org Gundersen Health System Center for Cancer and

UNDERSTANDING MULTIPLE MYELOMA AND LABORATORY VALUES Benjamin Parsons, DO bmparson@gundersenhealth.org Gundersen Health System Center for Cancer and UNDERSTANDING MULTIPLE MYELOMA AND LABORATORY VALUES Benjamin Parsons, DO bmparson@gundersenhealth.org Gundersen Health System Center for Cancer and Blood Disorders La Crosse, WI UNDERSTANDING MULTIPLE

More information

Smouldering myeloma. Myeloma Infosheet Series. Other related conditions Infoline:

Smouldering myeloma. Myeloma Infosheet Series. Other related conditions Infoline: Smouldering myeloma This Infosheet provides information on what smouldering myeloma is, how it is diagnosed, what the treatment is and will explain the link between smouldering myeloma and active myeloma.

More information

The ALIVE Trial: Amiodarone Versus Lidocaine In Pre-Hospital Refractory Ventricular Fibrillation Evaluation Introduction

The ALIVE Trial: Amiodarone Versus Lidocaine In Pre-Hospital Refractory Ventricular Fibrillation Evaluation Introduction The ALIVE Trial: Versus In Pre-Hospital Refractory Ventricular Fibrillation Evaluation Based on preliminary data of Dorian P et al as presented at the 22nd Annual Scientific Sessions of the North American

More information

MULTIPLE MYELOMA. Dr Malkit S Riyat. MBChB, FRCPath(UK) Consultant Haematologist

MULTIPLE MYELOMA. Dr Malkit S Riyat. MBChB, FRCPath(UK) Consultant Haematologist MULTIPLE MYELOMA Dr Malkit S Riyat MBChB, FRCPath(UK) Consultant Haematologist Multiple myeloma is an incurable malignancy that arises from postgerminal centre, somatically hypermutated B cells.

More information

I've Just Been Diagnosed. with Multiple Myeloma, What s Next?

I've Just Been Diagnosed. with Multiple Myeloma, What s Next? I've Just Been Diagnosed with Multiple Myeloma, What s Next? Table of Contents Message from a Survivor Introduction What is Multiple Myeloma? What Causes Multiple Myeloma? Genes & Multiple Myeloma What

More information

NCCN Practice Guidelines in Oncology Multiple Myeloma v

NCCN Practice Guidelines in Oncology Multiple Myeloma v NCCN Practice Guidelines in Oncology Multiple Myeloma v.3.2010 Summary of the Guidelines Update National Comprehensive Cancer Network Version 3.2010. Treatments Placed in New Categories: Primary Induction

More information

Multiple Myeloma Patient s Booklet

Multiple Myeloma Patient s Booklet 1E Kent Ridge Road NUHS Tower Block, Level 7 Singapore 119228 Email : ncis@nuhs.edu.sg Website : www.ncis.com.sg LIKE US ON FACEBOOK www.facebook.com/ nationaluniversitycancerinstitutesingapore Multiple

More information

Metastatic Bone Disease and Multiple Myeloma 16000122-01

Metastatic Bone Disease and Multiple Myeloma 16000122-01 Metastatic Bone Disease and Multiple Myeloma 16000122-01 1 Southwest Spine Institute Douglas S. Won, MD Spine Surgery Specialist Director of Southwest Spine Institute Clinical Asst. Professor, UT Southwestern

More information

Contractor Information. LCD Information. Contractor Name First Coast Service Options, Inc. Document Information LCD ID L32100

Contractor Information. LCD Information. Contractor Name First Coast Service Options, Inc. Document Information LCD ID L32100 Local Coverage Determination (LCD): Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications (L32100) Contractor Information Contractor

More information

Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial

Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Connie N. Hess, MD, MHS, Stefan James, MD, PhD, Renato D. Lopes, MD, PhD, Daniel M. Wojdyla,

More information

Issues Concerning Development of Products for Treatment of Non-Metastatic Castration- Resistant Prostate Cancer (NM-CRPC)

Issues Concerning Development of Products for Treatment of Non-Metastatic Castration- Resistant Prostate Cancer (NM-CRPC) Issues Concerning Development of Products for Treatment of Non-Metastatic Castration- Resistant Prostate Cancer (NM-CRPC) FDA Presentation ODAC Meeting September 14, 2011 1 Review Team Paul G. Kluetz,

More information

Metastatic Breast Cancer 201. Carolyn B. Hendricks, MD October 29, 2011

Metastatic Breast Cancer 201. Carolyn B. Hendricks, MD October 29, 2011 Metastatic Breast Cancer 201 Carolyn B. Hendricks, MD October 29, 2011 Overview Is rebiopsy necessary at the time of recurrence or progression of disease? How dose a very aggressive treatment upfront compare

More information

chronic leukemia lymphoma myeloma differentiated 14 September 1999 Pre- Transformed Ig Surface Surface Secreted Myeloma Major malignant counterpart

chronic leukemia lymphoma myeloma differentiated 14 September 1999 Pre- Transformed Ig Surface Surface Secreted Myeloma Major malignant counterpart Disease Usual phenotype acute leukemia precursor chronic leukemia lymphoma myeloma differentiated Pre- B-cell B-cell Transformed B-cell Plasma cell Ig Surface Surface Secreted Major malignant counterpart

More information

Outcomes of Placing Dental Implants in Patients Taking Oral Bisphosphonates: A Review of 115 Cases

Outcomes of Placing Dental Implants in Patients Taking Oral Bisphosphonates: A Review of 115 Cases DENTAL IMPLANTS J Oral Maxillofac Surg 66:223-230, 2008 Outcomes of Placing Dental Implants in Patients Taking Oral Bisphosphonates: A Review of 115 Cases Bao-Thy Grant, DDS,* Christopher Amenedo, DDS,

More information

New diagnostic criteria for myeloma

New diagnostic criteria for myeloma New diagnostic criteria for myeloma Dr Guy Pratt Senior Lecturer/Honorary Consultant Haematologist University of Birmingham/Heart of England NHS Trust International Myeloma Working Group (IMWG) define

More information

FEIST- WEILLER CANCER CENTER MULTIPLE MYELOMA GUIDELINES. Updated December, 2011. Authors: Nebu Koshy, MD. Binu Nair, MD. Gerhard Hildebrandt, MD

FEIST- WEILLER CANCER CENTER MULTIPLE MYELOMA GUIDELINES. Updated December, 2011. Authors: Nebu Koshy, MD. Binu Nair, MD. Gerhard Hildebrandt, MD FEIST- WEILLER CANCER CENTER MULTIPLE MYELOMA GUIDELINES Updated December, 2011 Authors: Nebu Koshy, MD Binu Nair, MD Gerhard Hildebrandt, MD Reinhold Munker, MD Glenn Mills, MD Mandatory initial tests

More information

International Myeloma Working Group Recommendations for the Treatment of Multiple

International Myeloma Working Group Recommendations for the Treatment of Multiple International Myeloma Working Group Recommendations for the Treatment of Multiple Myeloma Related Bone Disease Evangelos Terpos 1, Gareth Morgan 2, Meletios A. Dimopoulos 1, Noopur Raje 3, Niels Abildgaard

More information

by Charles (Chuck) Maack Prostate Cancer Advocate and Mentor Wichita, Kansas Chapter, Us TOO Intl., Inc.

by Charles (Chuck) Maack Prostate Cancer Advocate and Mentor Wichita, Kansas Chapter, Us TOO Intl., Inc. BISPHOSPHONATES & DENTAL CONSIDERATIONS by Charles (Chuck) Maack Prostate Cancer Advocate and Mentor Wichita, Kansas Chapter, Us TOO Intl., Inc. The below is information I have compiled and saved to my

More information

Urology Nurse Practitioner Urology Research Nurse Australian Prostate Cancer Research Centre Epworth November 18, 2011

Urology Nurse Practitioner Urology Research Nurse Australian Prostate Cancer Research Centre Epworth November 18, 2011 Urology Nurse Practitioner Helen Crowe Urology Nurse Practitioner Urology Research Nurse Australian Prostate Cancer Research Centre Epworth November 18, 2011 Nurse Practitioner Registered nurse who has

More information

The Use of Bisphosphonates in Patients With Breast Cancer

The Use of Bisphosphonates in Patients With Breast Cancer Bisphosphonates are effective in reducing skeletal-related complications associated with metastatic breast cancer. Philip Pearlstein. Jerusalem, Kidron Valley (detail), 1988. Heliorelief with roulette

More information

Bisphosphonates for breast cancer. Information for patients

Bisphosphonates for breast cancer. Information for patients Bisphosphonates for breast cancer Information for patients What are bisphosphonates? Bone constantly undergoes a process of renewal. Specialised bone cells break down old bone and replace it with new bone

More information

ASBMR FBandeira

ASBMR FBandeira ASBMR 2010 FBandeira WHI CaD The WHI CaD trial was a randomized, doubleblind, placebo-controlled trial that enrolled 36,282 postmenopausal women aged 51 82 years from 40 U.S. clinical centers. Women were

More information

A rare presentation of prostate cancer with diffuse osteolytic metastases and PSA of 7242 ng/ml

A rare presentation of prostate cancer with diffuse osteolytic metastases and PSA of 7242 ng/ml IJCRI 2011;2(9):16-20. Rajendiran et al. 16 CASE REPORT OPEN ACCESS A rare presentation of prostate cancer with diffuse osteolytic metastases and PSA of 7242 ng/ml Govarthanan Rajendiran, Linda Green,

More information

Monoclonal Gammopathy of Undetermined Significance (MGUS) Facts

Monoclonal Gammopathy of Undetermined Significance (MGUS) Facts Monoclonal Gammopathy of Undetermined Significance (MGUS) Facts Normal plasma cells (a type of white blood cell) produce antibodies (also known as immunoglobulins) which help fight infection. Each type

More information

Forteo (teriparatide) Prior Authorization Criteria

Forteo (teriparatide) Prior Authorization Criteria Forteo (teriparatide) Prior Authorization Criteria FDA APPROVED INDICATIONS AND DOSAGE 1 FDA Indication 1 : Forteo is indicated for: the treatment of postmenopausal women with osteoporosis who are at high

More information

Current Multiple Myeloma Treatment Adapted From the NCCN Guidelines

Current Multiple Myeloma Treatment Adapted From the NCCN Guidelines Current Multiple Myeloma Treatment Adapted From the NCCN Guidelines Diagnosis Survival 3-5 yrs Survival

More information

Bisphosphonate (BP) is used for the long-term

Bisphosphonate (BP) is used for the long-term CLINICIAN S CORNER Optimizing orthodontic treatment in patients taking bisphosphonates for osteoporosis James J. Zahrowski Tustin, Calif Bisphosphonates have unique pharmacological characteristics unlike

More information

Series 1 Case Studies Adverse Events that Represent Unanticipated Problems: Reporting Required

Series 1 Case Studies Adverse Events that Represent Unanticipated Problems: Reporting Required Welcome! This document contains three (3) series of Case Study examples that will demonstrate all four OHSU reporting categories (#1 4) as well as examples of events that are considered not reportable.

More information

A new score predicting the survival of patients with spinal cord compression from myeloma

A new score predicting the survival of patients with spinal cord compression from myeloma A new score predicting the survival of patients with spinal cord compression from myeloma (1) Sarah Douglas, Department of Radiation Oncology, University of Lubeck, Germany; sarah_douglas@gmx.de (2) Steven

More information

FastTest. You ve read the book... ... now test yourself

FastTest. You ve read the book... ... now test yourself FastTest You ve read the book...... now test yourself To ensure you have learned the key points that will improve your patient care, read the authors questions below. Please refer back to relevant sections

More information

Management of low grade glioma s: update on recent trials

Management of low grade glioma s: update on recent trials Management of low grade glioma s: update on recent trials M.J. van den Bent The Brain Tumor Center at Erasmus MC Cancer Center Rotterdam, the Netherlands Low grades Female, born 1976 1 st seizure 2005,

More information

POSITIVE TOP-LINE RESULTS FROM THE PHASE 3 STUDY OF ROMOSOZUMAB IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS

POSITIVE TOP-LINE RESULTS FROM THE PHASE 3 STUDY OF ROMOSOZUMAB IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS News Release POSITIVE TOP-LINE RESULTS FROM THE PHASE 3 STUDY OF ROMOSOZUMAB IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS FRAME Study Met All Primary Endpoints by Reducing the Incidence of New Vertebral Fracture

More information

Measure #257 (NQF 1519): Statin Therapy at Discharge after Lower Extremity Bypass (LEB) National Quality Strategy Domain: Effective Clinical Care

Measure #257 (NQF 1519): Statin Therapy at Discharge after Lower Extremity Bypass (LEB) National Quality Strategy Domain: Effective Clinical Care Measure #257 (NQF 1519): Statin Therapy at Discharge after Lower Extremity Bypass (LEB) National Quality Strategy Domain: Effective Clinical Care 2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY

More information

Myeloma bone disease and treatment options

Myeloma bone disease and treatment options EUROPEAN JOURNAL OF CANCER 42 (2006) 1554 1563 available at www.sciencedirect.com journal homepage: www.ejconline.com Myeloma bone disease and treatment options Howard S. Yeh, James R. Berenson* Institute

More information

SWOG ONCOLOGY RESEARCH PROFESSIONAL (ORP) MANUAL VOLUME I GENERAL FORMS AND GUIDELINES MYELOMA FORMS CHAPTER 16D REVISED: OCTOBER 2015

SWOG ONCOLOGY RESEARCH PROFESSIONAL (ORP) MANUAL VOLUME I GENERAL FORMS AND GUIDELINES MYELOMA FORMS CHAPTER 16D REVISED: OCTOBER 2015 MYELOMA FORMS The guidelines and figures below are specific to Myeloma studies. The information in this manual does NOT represent a complete set of required forms for any myeloma study. Please refer to

More information

January 2013 LONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Summary. Contents

January 2013 LONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Summary. Contents LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Paclitaxel albumin (Abraxane ) as a substitute for docetaxel/paclitaxel for cancer Paclitaxel albumin (Abraxane ) as a substitute for docetaxel/ paclitaxel for

More information

JACK L. SNITZER, D.O. INTERNAL MEDICINE BOARD REVIEW COURSE 2014

JACK L. SNITZER, D.O. INTERNAL MEDICINE BOARD REVIEW COURSE 2014 JACK L. SNITZER, D.O. INTERNAL MEDICINE BOARD REVIEW COURSE 2014 PARATHYROID AND CALCIUM METABOLISM JACK L. SNITZER, D.O. 1415 S. Division Street Suite A Salisbury, MD 21804 Phone:410-572-8848 Fax:410-572-6890

More information

Bisphosphonate therapy. osteonecrosis of the jaw

Bisphosphonate therapy. osteonecrosis of the jaw I overview Bisphosphonate therapy and osteonecrosis of the jaw Authors_Johannes D. Bähr, Prof. Dr Dr Peter Stoll & Dr Georg Bach, Germany _Introduction Fig. 1_Structural formula of pyrophosphate and basic

More information

Bone health in Duchenne muscular dystrophy. Hugo Sampaio

Bone health in Duchenne muscular dystrophy. Hugo Sampaio Bone health in Duchenne muscular dystrophy Hugo Sampaio Never mind the bones this is a MUSCULAR DYSTROPHY!! Fractures can be catastrophic Lead to significant pain May require surgery Happy bones Long life!

More information

Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing)

Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing) Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015 (minutes for web publishing) Cancer Treatments Subcommittee minutes are published in accordance with the Terms of Reference for the

More information

New Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013

New Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013 New Treatments for Stroke Prevention in Atrial Fibrillation John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013 Classification Paroxysmal atrial fibrillation (AF) Last < 7

More information

Multiple Myeloma. The term multiple myeloma is considered to be synonymous with myeloma, plasma cell myeloma, active and symptomatic myeloma.

Multiple Myeloma. The term multiple myeloma is considered to be synonymous with myeloma, plasma cell myeloma, active and symptomatic myeloma. Multiple Myeloma. The term multiple myeloma is considered to be synonymous with myeloma, plasma cell myeloma, active and symptomatic myeloma. The intent is to positively identify patients with active or

More information

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain P a g e 1 PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain Clinical Phase 4 Study Centers Study Period 25 U.S. sites identified and reviewed by the Steering Committee and Contract

More information

Cure versus control: Which is the best strategy?

Cure versus control: Which is the best strategy? Cure versus control: Which is the best strategy? Barcelona 8-9-2012 Mario Boccadoro DIVISIONE UNIVERSITARIA DI EMATOLOGIA AZIENDA OSPEDALIERA SAN GIOVANNI TORINO, ITALY MULTIPLE MYELOMA Cure versus control

More information

Novel Anticoagulation Agents DISCLOSURES. Objectives ATRIAL FIBRILLATION TRIALS. NOAC Comparison 6/12/2015

Novel Anticoagulation Agents DISCLOSURES. Objectives ATRIAL FIBRILLATION TRIALS. NOAC Comparison 6/12/2015 Novel Anticoagulation Agents DISCLOSURES James W. Haynes, MD Department of Family Medicine Univ of TN Health Science Center (Chattanooga) Objectives Understand mechanism of action behind the NOAC agents

More information

Subcutaneous Testosterone-Anastrozole Therapy in Breast Cancer Survivors. 2010 ASCO Breast Cancer Symposium Abstract 221 Rebecca L. Glaser M.D.

Subcutaneous Testosterone-Anastrozole Therapy in Breast Cancer Survivors. 2010 ASCO Breast Cancer Symposium Abstract 221 Rebecca L. Glaser M.D. Subcutaneous Testosterone-Anastrozole Therapy in Breast Cancer Survivors 2010 ASCO Breast Cancer Symposium Abstract 221 Rebecca L. Glaser M.D., FACS Learning Objectives After reading and reviewing this

More information

Understanding. Balloon Kyphoplasty and Myeloma-Induced Vertebral Compression Fractures

Understanding. Balloon Kyphoplasty and Myeloma-Induced Vertebral Compression Fractures Understanding Balloon Kyphoplasty and Myeloma-Induced Vertebral Compression Fractures International Myeloma Foundation 12650 Riverside Drive, Suite 206 North Hollywood, CA 91607 USA Telephone: 800-452-CURE

More information

Drug/Drug Combination: Bevacizumab in combination with chemotherapy

Drug/Drug Combination: Bevacizumab in combination with chemotherapy AHFS Final Determination of Medical Acceptance: Off-label Use of Bevacizumab in Combination with Chemotherapy for the Treatment of Metastatic Breast Cancer Previously Treated with Cytotoxic Chemotherapy

More information

Management of Osteoporosis in Pa1ents with Breast Cancer on Aromatase Inhibitor. Rukshini Puvanendran

Management of Osteoporosis in Pa1ents with Breast Cancer on Aromatase Inhibitor. Rukshini Puvanendran Management of Osteoporosis in Pa1ents with Breast Cancer on Aromatase Inhibitor Rukshini Puvanendran Kandang Kerbau Hospital KKH Women and Children s Hospital Breast Cancer and Bone Loss Pa1ents with breast

More information

DRUG NAME: Pamidronate

DRUG NAME: Pamidronate DRUG NAME: Pamidronate SYNONYM(S): Pamidronate disodium, pamidronic acid, APD, aminohydroxypropylidene bisphosphonate COMMON TRADE NAME(S): AREDIA CLASSIFICATION: Bone metabolism regulator Special pediatric

More information