Haematological Malignancies, Haematology, Multiple Myeloma CME ACCREDITED Watch Time: 44 mins

touchPANEL DISCUSSION Precision medicine in RRMM: Understanding how the data can be applied to practice

Watch a panel of experts discuss the latest advances in the treatment of relapsed and/or refractory multiple myeloma and the potential for precision medicine.

Prof. Philippe Moreau

University Hospital of Nantes, Nantes, France

CHAIR
Panelists:
Dr María-Victoria Mateos, Prof. Pieter Sonneveld
 
Video Chapters
Introduction

Clinical hematologist Prof. Philippe Moreau (Chair) introduces the panel, comprising a consultant physician in hematology and a professor of haematology, who are both involved in the management of patients with RRMM.

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Video Chapters
What are the key challenges in managing patients with RRMM?

The panel discusses the complex landscape of available therapeutic options for RRMM and how they can be utilized during the patient’s journey through different lines of therapy. 

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Video Chapters
How do the latest data on novel therapies contribute to outcomes in RRMM?

The latest data on emerging therapeutic agents are discussed by the panel in the context of their potential application in clinical practice, to fulfil some of the key unmet needs in the management of RRMM.

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Video Chapters
How can we move to a more personalized approach to RRMM treatment?

The panel discusses the need for a personalized approach to the management of patients with RRMM, the challenges posed by the complexity of the disease and how the latest advances will impact clinical practice.   

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Overview & Learning Objectives
Overview

In this activity, a panel of experts in RRMM discusses the latest advances in the treatment of relapsed and/or refractory multiple myeloma and the potential for precision medicine.

This activity has been jointly provided by USF Health and touchIME.       

Target audience

This activity has been designed to meet the educational needs of oncology and haematology specialists who are involved in the management of patients with RRMM.

Disclosures

USF Health adheres to ACCME Standards regarding commercial support of continuing medical education. It is the policy of USF Health that the faculty and planning committee disclose real or apparent conflicts of interest relating to the topics of this educational activity, that relevant conflict(s) of interest are resolved and also that faculty will disclose any unlabeled/unapproved use of drug(s) or device(s) during their presentation.

Faculty

Philippe Moreau discloses: Consultant/Advisory Board positions with AbbVie Inc., Amgen, Celgene/Bristol Myers Squibb, Janssen and Sanofi.

María-Victoria Mateos discloses: Consultant/Advisory Board positions with AbbVie, Adaptive, Amgen, Celgene, Genentech, GSK, Janssen, Oncopeptides, Pfizer, Regeneron, Roche, Sanofi and Takeda. Speaker’s Bureau for Amgen, Celgene, GSK, Janssen and Takeda.

Pieter Sonneveld discloses: Consultant/Advisory Board positions with Amgen, Celgene, Janssen and Karyopharm. Grant/Research Support from Amgen, Celgene, Janssen and Karyopharm.

Content Reviewer

Subrena Powell, MSN, AGACNP-BC has no conflicts of interest to disclose.

Touch Medical Director

Sola Neunie has no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity participants must review and complete the post-test evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

Accreditations

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 0.5 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 Credit™ into European CME credit (ECMEC) should contact the UEMS (www.uems.eu)

Advanced Practice Providers

Physician Assistants may claim a maximum of 0.5 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 Credit™ by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Date of original release: 8 December 2020. Date credits expire: 8 December 2021.

If you have any questions regarding credit please contact cpdsupport@usf.edu

Learning Objectives

After watching this activity, participants should be better able to:

  • Describe the current challenges in the treatment of multiple myeloma and considerations for overcoming poor prognosis
  • Discuss the efficacy and safety data of novel agents being investigated in patients with RRMM
  • Describe approaches to selecting treatment for patients with RRMM and the potential for precision medicine
Faculty & Disclosures
Prof. Philippe Moreau

University Hospital of Nantes, Nantes, France

Philippe Moreau, MD, serves as Professor of Clinical Hematology and head of the translational research program in hematology and oncology at the University Hospital of Nantes, France. Prof. Moreau’s clinical interests are focused on multiple myeloma and its treatment with high-dose therapy and novel agents. read more

Prof. Moreau is the chairman of the Intergroupe Francophone du Myélome (IFM). He has been vice-president of the International Myeloma Society (IMS) since 2019, and a member of the steering committee of the International Myeloma Working Group (IMWG) since 2013. He has served as the principal investigator (PI) or co-PI of many international randomized phase III clinical trials: Tourmaline (ixazomib for relapsed myeloma), Aspire (carfilzomib for relapsed myeloma), Endeavor (carfilzomib for relapsed myeloma), Stratus (pomalidomide for relapsed myeloma), Pollux (daratumumab for relapsed myeloma), Arrow (weekly versus biweekly carfilzomib for relapsed myeloma), Cassiopeia (daratumumab for frontline therapy in transplant eligible patients) and Ikema (isatuximab for relapsed myeloma). He was a member of the organizing committee for the 2011 International Myeloma Workshop in Paris.

Prof. Moreau’s research is widely published and he has authored or coauthored more than 300 peer-reviewed articles that have appeared in high-impact factor journals, including the New England Journal of Medicine, Journal of Clinical Oncology, Lancet, Lancet Oncology, and Blood. He is a member of the editorial boards of Blood and Blood Cancer Journal and is frequently invited to speak at international haematologic oncology meetings.

In 2018, Prof. Moreau received the Robert A. Kyle lifetime achievement award for his work in the field of multiple myeloma.

Philippe Moreau discloses: Consultant/Advisory Board positions with AbbVie Inc., Amgen, Celgene/Bristol Myers Squibb, Janssen and Sanofi. 
Dr María-Victoria Mateos

University of Salamanca, Salamanca, Spain

María-Victoria Mateos, MD, PhD, is Consultant Physician in the Haematology Department and Associate Professor of Medicine at the University of Salamanca, Spain. She is the director of the Myeloma Program and coordinates the Clinical Trials Unit in Salamanca’s University Hospital Haematology Department. read more

Dr Mateos’s areas of interest include multiple myeloma, the biology of plasma cells and new drug development. She serves as coordinator of GEM (Spanish Myeloma Group), with direct involvement in the design and development of clinical trials. She has coordinated many clinical trials in elderly and smouldering multiple myeloma (MM) patients, which have profoundly influenced current options for treating these patient populations.

She is also a member of the International Myeloma Working Group (IMWG), the International Myeloma Society (IMS), the European Hematology Association (EHA) and the American Society of Hematology (ASH). She has published over 200 papers in peer-reviewed international journals, some of which have become key references in the MM field. She is Associate Editor for myeloma in Annals of Haematology (since 2011) and has acted as a reviewer for top journals such as the New England Journal of Medicine, Lancet and Lancet Oncology. Among her invited presentations, she has contributed to the educational sessions of EHA 2012, ASH 2013, ASCO 2015, EHA 2016, ASCO and ASH 2017. She served on the EHA’s Scientific Program Committee and Advisory Board from 2013 until 2017, and on the ASH Scientific Committee on plasma cell diseases from 2015 until 2017.

Dr Mateos was a Councillor on the EHA Board from 2015 for a 4-year mandate and is a member of the Steering Committee for the Society of Hematologic Oncology (SOHO), of the IMS board and of the European School of Haematology (ESH) Scientific Committee.

María-Victoria Mateos discloses: Consultant/Advisory Board positions with AbbVie, Adaptive, Amgen, Celgene, Genentech, GSK, Janssen, Oncopeptides, Pfizer, Regeneron, Roche, Sanofi and Takeda. Speaker’s Bureau for Amgen, Celgene, GSK, Janssen and Takeda.
Prof. Pieter Sonneveld

Erasmus University, Rotterdam, The Netherlands

Pieter Sonneveld, MD, PhD was born in The Netherlands. He received his medical degree from Erasmus University in Rotterdam, The Netherlands in 1977. In 1980 he completed a PhD thesis on the pharmacology of adriamycin in acute leukemia at the University of Leiden. He received a Fogarty Fellowship and worked for several years at the National Cancer Institute, Bethesda, USA. read more

He is Professor of Hematology at the Erasmus MC and Erasmus University Rotterdam and has occupied the Chair of the Erasmus MC Cancer Institute in Rotterdam for 8 years. From 2011 to 2017 he was Head of the Department of Hematology. His research focus is on clinical and translational aspects of diagnostics and drug therapy in multiple myeloma. The myeloma research group in Erasmus MC has been very active in molecular diagnostics and prognostic systems. He has received numerous grants for his research.

Prof. Sonneveld is Chairman of the HOVON Myeloma Working Group and he coordinates HOVON and European Myeloma Network (EMN) clinical trials for multiple myeloma. He helped to found the EMN and has been its chairman since 2005. Within EMN, he coordinates a cooperative network for independent clinical trials in Europe and initiates efforts to create international standards for diagnostics and patient care.

He has been Board member (2011–present) and President (2017–19) of the European Hematology Association (EHA), and occupies the chair of its Scientific Working Group Committee. He has chaired the Scientific Program Committee of the 19th EHA congress in Milan 2014 and of the EMN Myeloma meetings in 2018 and 2020.

Prof. Sonneveld serves on the Scientific Advisory Boards of the International Myeloma Foundation (IMF) and the Multiple Myeloma Research Foundation (MMRF) and is a member of the International Myeloma Working Group. He has been a member of the Editorial Boards of Blood, Leukemia, European Journal of Cancer and Haematologica, and has authored more than 500 peer–reviewed scientific publications and several book chapters (H-factor 95).      

In 2015 he was awarded the prestigious international Robert A. Kyle lifetime achievement award for his work in multiple myeloma. In 2019 he received the Hubertus Wald Award for Cancer Research from Germany.

Pieter Sonneveld discloses: Consultant/Advisory Board positions with Amgen, Celgene, Janssen and Karyopharm. Grant/Research Support from Amgen, Celgene, Janssen and Karyopharm.
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This Activity Is Funded By:

An independent medical education request from AbbVie Inc. and Karyopharm Therapeutics. This activity is provided by touchIME.

The information provided by the CME activity is for continuing medical education purposes only and is not meant to substitute for the independent medical/clinical judgement of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME/CE to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME activities. touchIME accepts no responsibility for errors or omissions.

This content is intended for healthcare professionals.

Date of original release: 8 December 2020. Date credits expire: 8 December 2021.

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Question 1/5
Your patient is a 67-year-old man with multiple myeloma, who is relapsing 16 months after receiving first-line bortezomib, melphalan and prednisone. Which one of the following next steps would you consider?
CD, cluster of differentiation; mAb, monoclonal antibody.
 Correct

Patients experiencing disease relapse ≤18 months after first-line therapy have a poor prognosis1 and second-line treatment should take into consideration different factors, including the efficacy of previous treatments.2 ESMO guidelines indicate daratumumab in combination with lenalidomide plus dexamethasone as a second-line treatment option for patients with relapsed/refractory multiple myeloma whose previous treatment included a proteasome inhibitor and an immunomodulatory agent.2 Daratumumab in combination with lenalidomide and dexamethasone is approved by the EMA for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

EMA, European Medicines Agency; ESMO, European Society for Medical Oncology.

References

  1. Gay F, et al. Haematologica. 2018;103:197–211.
  2. Moreau P, et al. Ann Oncol. 2017;28:iv52–61.
  3. EMA. Daratumumab. Summary of product characteristics. 2020. Available at: www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf. Accessed 19 November 2020.
Question 2/5
Your patient is a 66-year-old man with multiple myeloma who relapsed 18 months after first-line treatment with melphalan, prednisone and thalidomide. You prescribed second-line treatment with daratumumab, bortezomib and dexamethasone. As part of his follow-up, his MRD is measured using NGS. Which of the following results would you consider as a minimum for the patient to be MRD negative?
MRD, minimal residual disease; NGS, next-generation sequencing.
 Correct

MRD is an important factor independently predicting prognosis during multiple myeloma treatment.1 Although not regularly used in clinical practice, its application has been increasingly common in clinical trials in order to meet the challenges in data evaluation and comparability between studies.2 MRD can be measured by either NGS or flow cytometry.2 In 2016, the International Myeloma Working Group (IMWG) introduced the definition of MRD in patients with complete response as the persistence or re-emergence of very low levels of cancer cells, equal to about 1 tumor cell in at least 105 normal cells.1

MRD, minimal residual disease; NGS, next-generation sequencing.

References

  1. Oliva S, et al. Front Oncol. 2020;10:1.
  2. Kriegsmann K, et al. Cancers (Basel). 2020;12:1–15.
Question 3/5
Your patient is a 72-year-old woman with multiple myeloma who has received four lines of therapy, which included different combinations of bortezomib, carfilzomib, lenalidomide, thalidomide, melphalan and daratumumab. She is now showing disease progression while on her fourth-line regimen. Based on data from the DREAMM-2 trial, which of the following regimens would you prescribe next?
Correct

Belantamab mafodotin is an anti-BCMA mAb-tubulin inhibitor conjugate that was investigated for the treatment of RRMM in the DREAMM-2 trial.1 Belantamab mafodotin was approved by the EMA and the FDA as monotherapy for the treatment of RRMM in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy.2,3

Selixenor is approved by the FDA for patients with RRMM after four prior therapies with disease refractory to proteasome inhibitors, immunomodulatory agents and an anti-CD38 mAb, but only in combination with dexamethasone.4

Isatuximab is an anti-CD38 mAb approved by the EMA and the FDA in combination with bortezomib and dexamethasone for the treatment of patients with RRMM who have received at least one prior treatment regimen including lenalidomide.5,6

BCMA, B-cell maturation antigen; CD, cluster of differentiation; EMA, European Medicines Agency; FDA, US Food and Drug Administration; mAb, monoclonal antibody; RRMM, relapsed and/or refractory multiple myeloma.

References

  1. Lonial S, et al. Lancet Oncol. 2020;21:207–21.
  2. EMA. Belantamab mafodotin. Summary of product characteristics. 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-information_en.pdf. Accessed 19 November 2020.
  3. FDA. Belantamab mafodotin. Prescribing information. 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf. Accessed 19 November 2020.
  4. FDA. Selixenor. Prescribing information. 2020. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2020/212306s001lbl.pdf. Accessed 19 November 2020.
  5. EMA. Isatuximab. Summary of product characteristics. 2020. Available at: www.ema.europa.eu/en/documents/product-information/imnovid-epar-product-information_en.pdf. Accessed 19 November 2020.
  6. FDA. Isatuximab. Prescribing information. 2020. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf. Accessed 19 November 2020.
Question 4/5
In line with the principles of precision medicine, which biomarkers would you test to determine if your patient has greater chances of clinical benefit from treatment with venetoclax in combination with bortezomib and dexamethasone (pending relevant agency approval)?
BCL2, B-cell lymphoma 2; LDH, lactate dehydrogenase; RRMM, relapsed and/or refractory multiple myeloma.
 Correct

Venetoclax is a BCL2 inhibitor, which was tested in the BELLINI trial in combination with bortezomib and dexamethasone (versus placebo plus bortezomib and dexamethasone) for the treatment of patients with RRMM who had received 1–3 prior lines of therapy.1 At a median follow-up of 28.6 months, PFS was 23.2 months in the venetoclax arm versus 11.4 months in the placebo arm. Serious adverse events occurred in 54% and 52% of patients in the venetoclax and placebo arms, respectively.1 Greatest PFS improvement with venetoclax was observed in patients with t(11;14) or high BCL2 gene expression, in whom venetoclax showed a favourable benefit–risk profile.1

Venetoclax is not yet approved for the treatment of patients with multiple myeloma outside of clinical trials.

BCL2, B-cell lymphoma 2; PFS, progression-free survival; RRMM, relapsed and/or refractory multiple myeloma.

References

  1. Kumar S, et al. J Clin Oncol. 2020;38(15 Suppl.):8509.
Question 5/5
When explaining the personalized approach to multiple myeloma treatment, which of the following statements best encapsulates the primary goals?
BCL2, B-cell lymphoma 2; LDH, lactate dehydrogenase; RRMM, relapsed and/or refractory multiple myeloma.
 Correct

The personalized approach to multiple myeloma treatment is designed to tailor treatment to the patient’s needs while providing the most effective treatment and minimizing the risks to the individual, e.g. by considering the patient’s comorbidities, concomitant medications and/or clinical characteristics.1

Using new biomarkers to improve prognostic models in multiple myeloma will certainly lead to the development of risk-adaptive therapeutic strategies, improving the outcome of this disease and paving the way towards precision therapy.1

References

  1. Ferreira B, et al. J Mol Med. 2020;98:513–25.
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