View
217
Download
0
Category
Preview:
Citation preview
CME INFORMATION
GOAL
The goal of this activity is to provide education and tools that help oncology nurses provide optimal care for patients with multiple myeloma within a shared decision making framework.
TARGET AUDIENCE
This activity is intended for oncology nurses and other healthcare providers who provide care for patients with multiple myeloma.
LEARNING OBJECTIVES
Upon completion of this activity, participants should be able to:
n Describe specific strategies to engage patients with multiple myeloma and their caregivers in shared decision making to make them an active participant in their care
n Educate patients with multiple myeloma on the anticipated adverse events of various treatment options so that they will be empowered to participate in treatment decision making
n Interact with patients with multiple myeloma and caregivers to evaluate resources for continuous education and support as a source of empowerment
FACULTY AND STAFF INFORMATION
Core Faculty:
Beth Faiman, PhD, MSN, APRN-BC, AOCNNurse Practitioner Cleveland Clinic Taussig Cancer Institute Cleveland, Ohio
Joseph D. Tariman, PhD, ANP-BCAssistant Professor DePaul University Chicago, Illinois
Faculty:
Page Bertolotti, RN, BSN, OCNClinical Practice NurseMultiple Myeloma and Amyloidosis ProgramSamuel Oschin Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California
Donna Catamero, ANP-BC, OCN, CCRCNurse PractitionerMount Sinai HospitalNew York, New York
Elizabeth Finley Oliver, RN, BSN, OCNPrimary RNDepartment of HematologyMoffitt Cancer CenterTampa, Florida
Sandra E. Kurtin, RN, MS, AOCN, ANP-CHematology/Oncology Nurse PractitionerClinical Assistant Professor of NursingClinical Assistant Professor of MedicineArizona Cancer CenterUniversity of ArizonaTucson, Arizona
Patricia Mangan, APRN, BCNurse LeadHematologic Malignancies/Bone Marrow and Stem Cell TransplantAbramson Cancer CenterUniversity of PennsylvaniaPhiladelphia, Pennsylvania
Kimberly Noonan, MS, RN, ANP, AOCNNurse Practitioner, Multiple MyelomaDana-Farber Cancer InstituteBoston, Massachusetts
Tiffany Richards, MS, ANP-BC, AOCNPNurse PractitionerDepartment of Lymphoma/MyelomaUniversity of Texas M. D. Anderson Cancer CenterHouston, Texas
Staff:
Terrence FaganAssociate Managing EditorClinical Care Options, LLC
Gordon KelleySenior Clinical EditorClinical Care Options, LLC
Kevin Obholz, PhDEditorial Director, Hematology/OncologyClinical Care Options, LLC
DISCLOSURE OF CONFLICTS OF INTEREST
The Annenberg Center assesses conflict of interest with its instructors, planners, managers, and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by the Annenberg Center for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. The Annenberg Center is committed to providing its learners with high-quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
The faculty and staff reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:
DISCLOSURE OF FACULTY AND STAFF FINANCIAL AFFILIATIONS
Faculty:
Page Bertolotti, RN, BSN, OCN, has disclosed that she has received fees for non-CME/CE services received directly from a commercial interest or their agents (eg, speaker bureaus) from Amgen, Celgene, and Takeda Oncology.
Donna Catamero, ANP-BC, OCN, CCRC, has disclosed that she has received consulting fees from Celgene and Takeda Oncology and fees for non-CME/CE services received directly from a commercial interest or their agents (eg, speaker bureaus) from Amgen, Celgene, Janssen, and Takeda Oncology.
Beth Faiman, PhD, MSN, APRN-BC, AOCN, has disclosed that she has received consulting fees and fees for non-CME/CE services received directly from a commercial interest or their agents (eg, speaker bureaus) from Amgen, Celgene, and Takeda Oncology.
Elizabeth Finley Oliver, RN, BSN, OCN, has disclosed that she has received consulting fees from Celgene and Takeda Oncology and fees for non-CME/CE services received directly from a commercial interest or their agents (eg, speaker bureaus) from Amgen and Celgene.
Sandra E. Kurtin, RN, MS, AOCN, ANP-C, has disclosed that she has received consulting fees from Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, and Takeda Oncology.
Patricia Mangan, APRN, BC, has disclosed that she has received consulting fees from Celgene and fees for non-CME/CE services received directly from a commercial interest or their agents (eg, speaker bureaus) from Amgen, Celgene, Novartis, and Takeda Oncology.
Kimberly Noonan, MS, RN, ANP, AOCN, has disclosed that she has no real or apparent conflicts of interest to report.
Tiffany Richards, MS, ANP-BC, AOCNP, has disclosed that she has received consulting fees from Celgene and Onyx.
Joseph D. Tariman, PhD, ANP-BC, has disclosed that he has no real or apparent conflicts of interest to report.
Terrence Fagan, Gordon Kelley, and Kevin Obholz, PhD, have no real or apparent conflicts of interest to report.
The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:
The following planners and managers, Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CHCP; Judi Smelker-Mitchek, RN, BSN; and Jan Schultz, RN, MSN, CHCP, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
Charles E. Willis, Director of Continuing Education from the Annenberg Center for Health Sciences at Eisenhower; Amanda Sewell, MBA, Manager of Continuing Education; Debbie Price, Database Administrative Secretary; and Alma Perez, Accreditation Specialist, from the Annenberg Center for Health Sciences at Eisenhower have no relevant commercial relationships to disclose.
DISCLOSURE OF UNLABELED USEThis educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The Annenberg Center, Clinical Care Options, and activity supporters do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the Annenberg Center, Clinical Care Options, and activity supporters. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
NURSING CONTINUING EDUCATION
Accreditation StatementAnnenberg Center for Health Sciences is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
Credit Designation 1.0 contact hour may be earned for successful completion of this activity.
California Board of Registered NursingProvider approved by the California Board of Registered Nursing, Provider Number 13664, for 1.0 contact hour.
INSTRUCTIONS FOR CREDIT (CME/CE) Participants wishing to receive continuing education credit must perform all of the following:
1. Sign in upon arrival with meeting staff and attend the full session.
2. Complete the program evaluation form verifying your attendance at the session and return to meeting staff prior to departure. No credit can be given without this documentation of attendance.
Final deadline for original CME/CE activity evaluation form submission: August 31, 2016
If you do not turn in the evaluation on site at the activity, pleaseSend to: Postgraduate Institute for Medicine, 304 Inverness Way South, Suite 100, Englewood, CO 80112 Attn: Errin Bilek or fax to: 303-790-4876
Certificates will be emailed within 4 weeks following the program.
There are no fees required to participate in this activity.
DISCLAIMER
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
1
New Approaches to Myeloma Treatment: What You Need to Know and What You Need to Tell Your Patients
Supported by educational grants from Amgen, Celgene Corporation, and Novartis.
Image: fotostorm/Copyright©2016 iStockphoto LP. All Rights Reserved
Core Faculty
Beth Faiman, PhD, MSN, APRN-BC, AOCNNurse Practitioner Cleveland Clinic Taussig Cancer Institute Cleveland, Ohio
Joseph D. Tariman, PhD, ANP-BCAssistant Professor DePaul University Chicago, Illinois
Agenda
The New Era of Shared Decision Making in Oncology
Clinical Updates in Multiple Myeloma
Advances in Therapy for Newly Diagnosed and Relapsed/Refractory MM
Moving Forward: Implementing SDM in Current Practice
2
The New Era of Shared Decision Making
i O lin Oncology
What is Shared Decision Making?
SDM is a model of treatment decision making in the pt encounter
4 essential elements:
1. 2 participants: healthcare providers (MD/APP/RNs) and pt
2. Both parties share information
3. Both parties take steps to build consensus about preferred treatment
4. Mutual agreement is reached between pt and healthcare member on treatment approach
Slide credit: clinicaloptions.com
The New Era of Shared Decision Making
In the past, paternalistic or provider-driven decision making model was dominant
Increased pt burden on cost and healthcare consumerism in US and elsewhere shifted the model from provider-driven to pt-centered care
All oncology nurses are involved in shared decision making[1]; nurses are a trusted source of pt information[2]
1. Tariman J, et al. Clin J Oncol Nurs. 2015;19:548-556. 2. Tariman J, et al. Ca Treat Comm. 2014;2:34-37. 3. http://www.ahrq.gov. 4. Institute of Medicine Committee on Quality of Health Care in America. 5. Patient Protection and Affordable Care Act. 6. AACN Competencies for Baccalaureate and Graduate Nurses.
Emphasis on pt-centered care
– Agency for Healthcare Research and Quality[3]
– Institute of Medicine Committee on Quality of Health Care in America[4]
– Patient Protection and Affordable Care Act[5]
– American Association of Colleges of Nursing competency[6]
Slide credit: clinicaloptions.com
3
Implementing SDM in MM
Study on preferences for participation in treatment decision making in pts newly diagnosed with active myeloma (N = 20)
– 95% preferred to have some role
Breakdown of role preferences:
– 55% preferred a shared role with provider
– 40% preferred to make decisions after seriously considering opinion of their provider
– 5% (n = 1) preferred to leave decisions to provider, as long as pt’s treatment preferences are considered
Tariman JD, et al. Oncol Nurs Forum. 2014;41:411-419. Slide credit: clinicaloptions.com
Short-term Benefits Long-term Outcomes
Increased confidence with treatment decisions
Higher satisfaction with treatment decisions Enhanced trust in healthcare team Improved self-efficacy
Treatment adherence Better quality of life Improved treatment
outcomes: disease remission
Pt Benefits of SDM
Avoidance of decisional regrets Decreased pt/caregiver stress and anxiety
related to cancer treatment decisions
Kane HL, et al. CA Cancer J Clin. 2014;64:377-388. Slide credit: clinicaloptions.com
What Are the Roles of the Nurse in SDM?
Patient
Patient Education
Psychological Support
Information Sharing With
Multidisciplinary Team
Adapted from Tariman JD, et al. Clin J Oncol Nurs. 2015;19:548-556.
Assessment, Monitoring,
Management of Treatment Side
EffectsAdvocacy
Outcomes Evaluation
Slide credit: clinicaloptions.com
4
Information Sharing With Multidisciplinary Team
Role of nurse in SDM needs to be strengthened to improve the representation of pts’ interests[1]
Multidisciplinary team approach common in many tumor types: lung,[2] head and neck,[3] colorectal,[4]
breast cancer [5] and othersbreast cancer,[ ] and others
1. Lamb BW, et al. Urol Nurs. 2014;34:83-91. 2. Leo F, et al. J Thorac Oncol. 2007:2:69-72. 3. Stalfors J, et al. Acta Otolaryngol. 2007;127:82-87. 4. Wood JJ, et al. Colorectal Dis. 2008;10:769-772. 5. Jenkins VA, et al. Qual Health Care. 2007;10:70-75. Slide credit: clinicaloptions.com
Pt Education and Information Giving
Study on treatment decision making in older adults diagnosed with symptomatic myeloma identified nurses as one of the sources of information[1]
Clinical nurse specialists are a reliable source of information for pts[2]
The nurse is THE MOST TRUSTED healthcare team member di t th 2015 G ll [3] i ll taccording to the 2015 Gallup survey,[3] so nurses are in an excellent
position to advocate for pts[1,2,4]
– Practice implications:
– Respect pt’s autonomy
– Acknowledge pt’s right to self-determination
– Ensure informed treatment decisions
1. Tariman JD, et al. Cancer Treat Commun. 2014;2:34-47. 2. Thornton M, et al. Int J Palliat Nurs. 2011;17:68-74. 3. Gallup.com. Accessed April 8, 2016. 4. Tariman JD, et al. Oncol Nurs Forum. 2014;41:411-419. Slide credit: clinicaloptions.com
Advocacy
Nurses have a critical role in encouraging pt autonomy related to ethical discussions[1]
1. Breier-Mackie S. Nurs Ethics. 2001;8:510-521. Slide credit: clinicaloptions.com
5
Psychological Support Role
Pivotal role in helping pts achieve decision satisfaction during phase I trials by allowing them to talk about what is important in their lives and searching a way to live life until the end satisfactorily[1]
During end-of-life care, nurses provide guidance and support to pts and families during their difficult decisions on artificial feeding[2] and withholding life-supporting measures[3]
Vital roles in providing emotional support to women following early breast cancer treatment in order to help them feel satisfied with their decisions and prevent psychological distress[4]
1. Ohara K, et al. Oncol Nurs Forum. 2010;37:E124-E132. 2. Bryon E, et al. J Adv Nurs. 2008;63:2-14. 3. Bouley G. Dimens Crit Care Nurs. 2011;30:321-325. 4. Budden LM, et al. Int J Nurs Pract. 2014;20:8-16. Slide credit: clinicaloptions.com
Complex Role of Nurses in SDM
Community nurse role in bereavement care in context of uncertainty[1]
Influenced by many variables, including:
l ti hi hi h
TaskTask
Task
TaskTask
Task
Task
Task
Task
Task
Task
Role
Role Role
S f
Reason
P relationships, hierarchy, power, leadership, education, experience, and responsibility[2]
Complex role during difficult and controversial treatment decisions[3]
1. Brownhill S, et al. Br J Community Nurs. 2013;18:133-139. 2. Hancock HC, et al. Int J Nurs Stud. 2006;43:693-705.3. Tariman JD, et al. Clin J Oncol Nurs. (In press.)
Task
Task
Task
TaskTask
TaskTask
Task
Task
Task
Task
Task
TaskRole
Role
Role
Role
Role
Self Purpose
Self-Esteem
Slide credit: clinicaloptions.com
Clinical Updates in Multiple MyelomaMultiple Myeloma
6
What Is Multiple Myeloma?
Cancer of the plasma cells
2016: 30,330 new cases
Median age: 69 yrs
Abnormal plasma cells
Produce
Causes: chemicals, environment
44.9% will survive at 5 yrs; MM pts are survivors
Faiman B, et al. Multiple myeloma. In: Hematologic malignancies in adults. ONS Publishing. 2014.SEER stat fact sheets: myeloma. Siegel RL, et al. CA Cancer J Clin. 2016;66:7-30.
↑ circulating abnormal serum proteins
Genetic and molecular defects
Slide credit: clinicaloptions.com
100
80
60
res
sio
n (
%)
51
6673
78
MGUS
Smoldering MM
Progression to Symptomatic MM
15% more will convert over next 5 yrs and then 1% per yr thereafter
40
20
0
51% will convert in first 5 yrs~ 10% per yr
0 5 10 15 20 25
Pro
gr
4 1016
21
Strategy: identify pts with high risk of progression; suggest early treatment before organ damage occurs
Kyle RA, et al. N Engl J Med. 2007;356:2582-2590.Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-e548.
Yrs Since Diagnosis
Slide credit: clinicaloptions.com
MM: Clinical Manifestations
Series of genetic mutations, translocations, normal cell turns malignant.Hallmarks of myeloma: CRAB (also known as myeloma defining events).
Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-e548. Slide credit: clinicaloptions.com
R = RenalInsufficiency
B = Bone Disease
A = Anemia
C = Calcium Elevation
Recurrent infections*
*Not an MDE, yet relatively common
7
Updated IMWG Criteria for Diagnosis of Multiple Myeloma
•MGUS
M protein < 3 g/dL
Clonal plasma cells in BM < 10%
No myeloma-defining events
•Smoldering Myeloma
M protein ≥ 3 g/dL (serum) or ≥ 500 mg/24 hrs (urine)
Clonal plasma cells in BM ≥ 10% to 60%
No myeloma-defining events
•Multiple Myeloma
Underlying plasma cell proliferative disorder
AND 1 or more myeloma-defining events
≥ 1 CRAB* feature
Cl l l ll i BM
*C: Calcium elevation (> 11 mg/dL or > 1 mg/dL higher than ULN)R: Renal insufficiency (CrCl < 40 mL/min or serum creatinine > 2 mg/dL)A: Anemia (Hb < 10 g/dL or 2 g/dL < normal)B: Bone disease (≥ 1 lytic lesions on skeletal radiography, CT, or PET/CT)
Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-e548.
Clonal plasma cells in BM ≥ 60%
Serum free light-chain ratio ≥ 100
> 1 MRI focal lesion
Slide credit: clinicaloptions.com
Lab tests: Serum protein electrophoresis (SPEP)
Urine protein electrophoresis (UPEP)
Complete metabolic panel (CMP)
CBC + differential
Plasma ratio of free kappa/lambda light chains
Diagnostic Workup
pp g
Monoclonal protein analysis (MPA)
Bone marrow biopsy: FISH, cytogenetics, and gene expression profiling (GEP)
Imaging: Skeletal survey
MRI, CT
PET scan ± MRI, CT
Genetic changes occur
Ghobrial IM, et al. Blood. 2014;124:3380-3388. Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-3548. Faiman B. Clin Lymphoma Myeloma Leuk. 2014;14:436-440. Slide credit: clinicaloptions.com
When and Why Should a Clinical Trial Be Considered?
Before organ damage occurs (preferred)
Clinical trials (preferred)
– Emphasize pros—benefits—of clinical trials
– Access to new drugsAccess to new drugs
– Collect information in logical manner
– Can benefit pt, others
– Cons and risks also exist and should be discussed with pts, caregivers
– Stringent monitoring, placebo, etc
Ghobrial IM, et al. Blood. 2014;124:3380-3388. Slide credit: clinicaloptions.com
8
Advances in Therapy for Newly Diagnosed and
R l d/R f t MMRelapsed/Refractory MM
NCCN Preferred Regimens
Other NCCN Regimens
Initial therapy (induction) for transplantation-eligible pts (response assessment
Category 1 Bort/dox/dex Rd RVd VD
Category 2A IRd KRd
Category 2B Dexamethasone
Induction and Maintenance Therapy for Transplantation-Eligible Pts With MM
p ( pafter cycle 2) VTD
Category 2A CyBorD
Liposomal dox/vin/dex Thal/dex
Maintenance therapy
Category 1 Lenalidomide Thalidomide
Category 2A Bortezomib
Category 2B VP VT Interferon Steroids Thal + pred
NCCN. Clinical practice guidelines in oncology: multiple myeloma. v.3.2016. Slide credit: clinicaloptions.com
NCCN Preferred Regimens
Other NCCN Regimens
Initial therapy (induction) for transplantation-ineligible pts (response
Category 1 Rd RVd MPR MPT
Category 2A IRd MP
Category 2B Dexamethasone
Induction and Maintenance Therapy for Transplantation-Ineligible Pts With MM
ineligible pts (response assessment after cycle 2)
MPVCategory 2A
VD CyBorD
Liposomal dox/vin/dex Thal/dex Vin/dox/dex
Maintenance therapy
Category 1 Lenalidomide Thalidomide
Category 2A Bortezomib
Category 2B VP VT Interferon Steroids Thalidomide + prednisone
Slide credit: clinicaloptions.comNCCN. Clinical practice guidelines in oncology: multiple myeloma. v.3.2016.
9
“Best” Treatment for the Pt?
With so many available therapies, how does one choose the “best”?
Guidelines exist to “guide” decision making
Consider:
– Prevention of further organ damage (if present)
– Age, morbidities, desire, financial, social status
– Biomarkers/cytogenetic risk group (high or low)
– 2 drugs, 3 drugs, or more?
– Pt preferences and goals
– Clinical trial availability
– Quality of life
Palumbo A, et al. J Clin Oncol. 2014;32:587-600. Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-3548. Slide credit: clinicaloptions.com
IP CR
sCR
mCR
CR
Monitoring Disease is Essential: IMWG Myeloma Response Criteria
Category Response Criteria
sCR Normal FLC ratio; no clonal BM plasma cells
CR Negative IFX and < 5% BM plasma cells
VGPR Positive IFX and negative SPEP; ≥ 90% urine protein decrease; urine M-protein level
100 /24 h
Better
VGPR
PR
MR
SD
Slide credit: clinicaloptions.comPalumbo A, et al. J Clin Oncol. 2014;32:587-600. Durie BM, et al. Leukemia. 2006;20:1467-1473.
< 100 mg/24 hrs
PR ≥ 50% decrease serum M-protein and ≥ 90% decrease in 24-hr urinary M-protein
SD Not meeting criteria for CR, VGPR, PR, or progressive disease
IP CR: sCR AND BM negative by next gen flow (10-6)
sCR: CR AND normal FLC ratio, BM negative by flow, 2 measures
mCR: CR AND negative PCR (10-5)
CR: negative IFX; < 5% PC in BM; 2 measures
PDWorse
NCCN Preferred Regimens Other NCCN Regimens
Category 1 Bortezomib Bortezomib/liposomal doxorubicin Elotuzumab/len/dex Ixazomib/len/dex KRd Rd Pan/bort/dex
Category 2A Bendamustine Bortezomib/vorinostat Bendamustine/len/dex
Recommended Regimens for Pts With Relapsed/Refractory MM
Pan/bort/dex Pom/dex
Category 2A CyBorD, RVd, VD, VCD, VTD Carfilzomib, carfilzomib/dexamethasone Cyclo/len/dex Daratumumab DCEP DT-PACE ± bortezomib High-dose cyclophosphamide Thalidomide/dexamethasone Repeat primary induction Tx if relapse at > 6 mos
NCCN. Clinical practice guidelines in oncology: multiple myeloma. v.3.2016. Slide credit: clinicaloptions.com
10
Factors in Selecting Treatment for Relapsed/Refractory Myeloma
Disease-related factors
– Duration of response to initial therapy
– High-risk vs low-risk status
– Biochemical disease progression, or symptomatic?
Other comorbid conditions– Other comorbid conditions
– PATIENT PREFERENCE
Treatment-related factors
– Previous therapy exposure (relapsed or refractory)
– Toxicity of regimen (combination vs single agent)
– Mode of administration (ie, oral or IV)
– Cost and convenience (out of pocket copays for IV vs oral)
Slide credit: clinicaloptions.com
New Agents and Regimens Approved for RRMM in 2015
TreatmentNumber of Previous
Lines of Therapy
Carfilzomib (proteasome inhibitor) + lenalidomide + dexamethasone*
1-3
Elotuzumab (anti-SLAMF7 mAb) + lenalidomide + dexamethasone
1-3
Ixazomib (proteasome inhibitor) + lenalidomide + dexamethasone
≥ 1
Panobinostat (HDAC inhibitor) + bortezomib + dexamethasone
≥ 2
Daratumumab (CD38-targeted mAb) monotherapy
≥ 3
Slide credit: clinicaloptions.com
*Carfilzomib monotherapy 20/56 mg/m2 IV previously approved for pts with RRMM.
ASPIRE: Rd ± Carfilzomib in RRMM
Outcome KRd(n = 396)
Rd (n = 396)
Significance
ORR, % 87.1 66.7 P < .001
Median PFS, mos 26.3 17.6 HR: 0.69; P = .0001
Phase III trial
Interim OS results did not meet prespecified statistical boundary (P = .005)
AEs consistent with previous studies; no unexpected toxicities observed
– Grade ≥ 3 cardiac failure and ischemic heart disease: 3.8% and 3.3% in KRd arm vs 1.8% and 2.1% in Rd arm, respectively
Stewart AK, et al. N Engl J Med. 2015;372:142-152. Slide credit: clinicaloptions.com
2-yr OS, % 73.3 65.0 HR: 0.79; P = .04
11
PANORAMA 1: Bort/Dex ± Panobinostat in RRMM
Subgroup analysis of phase III trial of pts who received ≥ 2 previous treatments, including bortezomib and an IMiD
Outcome Pan/Bort/Dex(n = 73)
Bort/Dex(n = 74)
Significance
1. Richardson PG, et al. Blood. 2016;127:713-721.2. San Miguel J, et al. ASH 2015. Abstract 3026. Slide credit: clinicaloptions.com
(n = 73) (n = 74)
ORR, %[1] 58.9 39.2 P = .017
Median PFS, mos[1] 12.5 4.7 HR: 0.47
Median OS, mos[2] 25.5 19.5 Not significant
TOURMALINE-MM1: Rd ± Ixazomib in RRMM—Efficacy
CharacteristicIxazomib + Rd
(n = 360)Placebo + Rd
(n = 362)P Value
Median PFS, mos 20.6 14.7 .012*
ORR, % CR
78.311.7
71.56.6
.035
.019
Phase III trial (N = 722)
PFS benefit with ixazomib seen in all prespecified subgroups, including cytogenetic high risk, PI and IMiD exposed
Moreau P, et al. ASH 2015. Abstract 727.
CR VGPR PR
11.736.466.7
6.632.364.9
.019
Median time to response, mos 1.1 1.9
Median DoR, mos 20.5 15.0
Median TTP, mos 21.4 15.7 .007†
*HR: 0.742. †HR: 0.712.
Slide credit: clinicaloptions.com
ELOQUENT-2: Rd ± Elotuzumab—Efficacy
OutcomeElotuzumab + Rd
(n = 321)Rd
(n = 325)HR (95% CI)
PFS Median, mos 1 yr, % 2 yrs, %
19.46841
14.95727
0.73 (0.60-0.89;P = .0014)
PFS benefit seen with elotuzumab in all predefined subgroups
Dimopoulos MA, et al. ASH 2015. Abstract 28.
3 yrs, % 26 18
Median time to next treatment, mos
33 21 0.62 (0.50-0.77)
ORR, % 79 66
Interim OS, mos 43.7 39.60.77 (0.61-0.97;
P = .0257)
Slide credit: clinicaloptions.com
12
Elotuzumab + Rd: Dose and Schedule
Cycles 1 and 2 (28-Day Cycles)
Day of cycle 1 8 15 22
Elotuzumab, mg/kg (IV) 10 10 10 10
Lenalidomide, 25 mg (PO) QD
Dexamethasone, mg (PO/IV) 28/8 28/8 28/8 28/8
Cycles 3 and Beyond (28-Day Cycles)
Implications: Infusion reaction prevention: Dex 28mg 3-24 hrs prior; Dex 8 mg IV 1 hr prior; H1, H2,
and acetaminophen premed 45-90 mins prior
HSV prophylaxis
DVT prophylaxis (lenalidomide)
Elotuzumab [package insert]. 2015.
Day of cycle 1 8 15 22
Elotuzumab, mg/kg (IV) 10 10
Lenalidomide, 25 mg (PO) QD
Dexamethasone, mg (PO/IV) 28/8 40/0 28/8 40/0
Slide credit: clinicaloptions.com
SIRIUS: Daratumumab in R/R Myeloma
Phase II trial; pts were heavily pretreated
Reductions in paraprotein occurred in majority of pts
Responses observed across subgroups
Deepening of responses with continued treatment
– Median time to response: 1 mo– Median time to response: 1 mo
Lonial S, et al. Lancet. 2016;[Epub ahead of print]. Slide credit: clinicaloptions.com
Outcome Daratumumab(n = 106)
95% CI
ORR, % 29.2 20.8-38.9
Median PFS, mos 3.7 2.8-4.6
1-year* OS, % 65 51.2-75.5
Median DoR, mos 7.4 5.5-NE
*Median OS not reached.
Daratumumab: Safety, Dose, and Schedule
Daratumumab-related sAEs[2]
Dosing Schedule (16 mg/kg IV)[1] Wks
Weekly 1-8
Every 2 wks 9-24
Every 4 wks 25+ until disease progression
1. Daratumumab PI. 2015.2. Lonial S, et al. Lancet. 2016;[Epub ahead of print].
– Pneumonia, neutropenia, diarrhea (1 pt each receiving 16 mg/kg, early infusion program)
– Laryngeal edema (1 pt receiving 16 mg/kg, accelerated infusion program)
– 19 of 45 pts reported infusion-related reactions; mostly grade 1/2
Must pre/post medicate with hydrocortisone
Montelukast 10 mg and loratadine 10 mg night before and for 48 hrs after infusion
Type/cross match and antibody workup necessary
Slide credit: clinicaloptions.com
13
Promising Agents in Clinical Trial for MM
Agent MOA Phase in Development
Ibrutinib Tyrosine kinase inhibitor III
Oprozomib Proteasome inhibitor III
Filanesib Kinesin spindle protein
inhibitorII
MOR202 (MOR03087) Anti-CD38 mAb I/II
Indatuximab ravtansine CD138 antibody–drug
conjugateI/II
Ricolinostat HDAC inhibitor I/II
Selinexor (KPT-330)XPO1 nuclear transport
inhibitorI/II
Isatuximab (SAR650984) Anti-CD38 mAb Ib
Venetoclax Selective BCL-2 inhibitor I
Clinicaltrials.gov Slide credit: clinicaloptions.com
AEs Commonly Associated With MM Therapeutic Agents
X X X X X X X
X X X X X X X X X
X X X X X X X X
X X X X X X X X X X X X
Bortezomib
Carfilzomib
Thalidomide
Lenalidomide
PIs
IMiDs
Colson K. Support Care Cancer. 2015;23:1431-1445.
X X X X X X X X
X X X X X X
X X X X X X
X X X X X X X X
X X X X X X X X
X X X X X X X
X X X X X
X X X X X X X
X X X
Pomalidomide
Cyclophosphamide
Melphalan
Dexamethasone
Prednisone
Panobinostat
Vorinostat
Elotuzumab
Daratumumab
Chemotherapy
mAbs
HDACis
Corticosteroids
Slide credit: clinicaloptions.com
MM Treatment: Key AEs, Considerations
Drug Class Name Key AEs Nursing Considerations
Proteasome inhibitorsBortezomib PN, T, M, F
IV, SC; monitor platelets; safe in renal failure
CarfilzomibPN, C, M, F,
DVTHydration,
cardio/pulmonary
ASA or LMWH if high risk
Immunomodulatory agents
LenalidomideDVT, M, BD, R,
D
ASA or LMWH if high risk for clots; weekly CBC x 8
wks
Thalidomide DVT, M, BD As above
Pomalidomide DVT, M, BD, F As above
Monoclonal antibodiesDaratumumab IR, M, RD
Infusion reaction risk; pre/post med as directed;
interrupt infusion if reaction
Elotuzumab IR, M, RD As above
US Food and Drug Administration. FDA approved drug products. Slide credit: clinicaloptions.com
14
MM Treatment: Key AEs, Considerations
Drug Class NameKey Side Effects
Nursing Considerations
Alkylating agentsMelphalan M, N
CBC diff monthly; renal dose adjustment
Cyclophosphamide M, N CBC diff monthly; renal
dose adjustment y p p j
CorticosteroidsPrednisone H, MS
Monitor blood sugar, insomnia, weight gain
Dexamethasone H, MS Above
HDAC inhibitors Panobinostat C, DBaseline EKG and mag/K+ monitoring;
loperamide for diarrhea
US Food and Drug Administration. FDA approved drug products. Slide credit: clinicaloptions.com
Proper Dosing of Drugs Can Minimize AEs
Drug
Dosing Based on Risk Factors* Including Age
No Risk FactorsAt Least 1 Risk Factor
Adjusted Dose
At Least 1 Risk Factor Plus Occurrence of Grade
3/4 Nonhematologic AE
Bortezomib1.3 mg/m2 2x/wk
Days 1, 4, 8, 11 q3w1.3 mg/m2 qw
Days 1,8,15,22 q5w1.0 mg/m2 qw
Days 1,8,15,22 q5w
Lenalidomide25 mg/day 15 mg/day 10 mg/day
*Geriatric assessment, risk factors:– Older than 75 yrs of age– Mild, moderate, or severe frailty (eg, weakness, poor endurance, weight loss, low physical
activity, and slow gait speed)– Comorbidities: cardiac, pulmonary, hepatic, or renal dysfunction
Slide credit: clinicaloptions.com
LenalidomideDays 1-21 of 28-day cycle Days 1-21 of 28-day cycle Days 1-21 of 28-day cycle
Dexamethasone40 mg/wk
Days 1, 8, 15, 22 q4w20 mg/wk
Days 1, 8, 15, 22 q4w10 mg/wk
Days 1, 8, 15, 22 q4w
Melphalan0.25 mg/kg or 9 mg/m2
Days 1-4 q4-6w0.18 mg/kg or 7.5 mg/m2
Days 1-4 q4-6w0.13 mg/kg or 5 mg/m2
Days 1-4 q4-6w
Thalidomide 100 mg/day 50 mg/day 50 mg/day
Palumbo A, et al. Blood. 2015;125:2068-2074. Palumbo A, et al. Blood. 2011;118:4519-4529.
Moving Forward: Implementing SDM in Current PracticeSDM in Current Practice
15
1 Invite pt to participate
Usually at least 2 treatment options available to pt. Inviting pt to participate informs pt that more than 1 option exists and that pt preferences and values could influence treatment decision
2 Present options Pt must receive information on available treatment options
6 Steps in Implementing SDM in Oncology
3 Provideinformation on benefits and risks
Discuss with pt pros and cons of available treatment options based on medical evidence. Verify pt understanding by asking pt to repeat information shared by provider
Kane HL, et al. CA Cancer J Clin. 2014;64:377-388. Slide credit: clinicaloptions.com
4 Assist pt in evaluatingoptions based on goals and concerns
Ask pt about personal preferences, values, issues, and concerns related to treatment options
5 Facilitate deliberation and decision making
Allow ample time for pt to think about treatmentoptions. Facilitate another visit to discuss any further pt questions or concerns
6 Steps in Implementing SDM in Oncology
further pt questions or concerns
6 Implement SDM Ensure that pt understands treatment decision and explore possible issues with implementation
Kane HL, et al. CA Cancer J Clin. 2014;64:377-388. Slide credit: clinicaloptions.com
Barrier Examples
Practice Limited time during pt encounter Time away from other pts Commitment by all multidisciplinary team members
Patient Unwilling pt Difference in goals between pt and caregiver
Barriers to Implementing SDM
Institutional Lack of policy or time commitment
Scope of Practice Laws and guidelines prohibiting autonomous
practice
Administration Inadequate support by administration
McCarter SP, et al. Sigma Theta Tau International’s 26th International Nursing Research Congress. 2015. Slide credit: clinicaloptions.com
16
Documented Challenges/Barriers to SDM
ICU nurses’ involvement in end-of-life decision making processes
– Relatives of pts wanted more involvement from nurses[1]
Roles of acute care NP
– Highly context sensitive
– Roles largely depend on laws regulating scope of practice and healthcare system policies[2]system policies[2]
Pts who have advanced cancer
– Need clarification of specific roles of nurses during different stages of treatment decision making[3]
Role of nurses in clinical decision making
– More research studies that address specific contributions
– Potentially lead to improvement of healthcare outcomes[4]
1. Lind R, et al. Nurs Ethics. 2012;19:666-676. 2. Kilpatrick K, et al. Int J Nurs Stud. 2013;50:1524-1536. 3. McCullough L, et al. Eur J Cancer Care. 2010;19:482-491. 4. Campos DC, et al. Rev Lat Am Enfermagem. 2009;17:1065-1070. Slide credit: clinicaloptions.com
SDM in MM: Conclusions
There is a shift in the dialogue related to cancer treatment decision making between pts and physicians, as well as oncology nurses
The roles of the nurse during the cancer treatment decision making process are multifaceted: advocacy, education, psychological support, adverse event management
The role of the oncology nurse during cancer treatment decisions is dynamic and continuously influenced by many factors
Nursing advocacy must be encouraged and strengthened to improve pt outcomes
Slide credit: clinicaloptions.com
SDM in MM: Conclusions
Older adults newly diagnosed with MM want to participate in treatment decision making
The wide range of treatment options and the recent addition of 5 new approvals for MM treatment make pt education essential
Pts with MM are living longer than ever and SDM is important toPts with MM are living longer than ever and SDM is important to quality, quantity of life
Oncology nurses must respect the pt’s desired role preference and all oncology practitioners must listen to the pt
Allow pts to be autonomous in making treatment decisions and provide opportunity for pts to choose the best possible treatment within the limits of the pt’s personal, social, and medical contexts
Slide credit: clinicaloptions.com
17
Go Online for More CCO Oncology Programs for Nurses!
Nursing-focused Educational Programs on cancer immunotherapy, B-cell malignancies, mantle cell lymphoma, more.
More than 1200 inPractice® pages addressing the nurse’s roles in the management of patients with cancer.
clinicaloptions.com/oncology
inPractice.com
Backup Slides
ASPIRE: Len/Dexamethasone ±Carfilzomib in RRMM—Study Design
Planned interim analysis of a randomized, open-label phase III trial
Pts with relapsed or i MM
KRdCarfilzomib Days 1, 2, 8, 9, 15, 16/cycles 1-12,
Days 1, 2, 15, 16/cycles 13-18,discontinued after cycle 18 +Lenalidomide Days 1-21 +
Stratified by β2-microglobulin, prior bortezomib, and prior lenalidomide
progressive MM, 1-3 prior treatments
with ≥ PR in ≥ 1 prior regimen,
ECOG PS 0-2, and CrCl ≥ 50 mL/min
(N = 792)
Until PD or unacceptable toxicity
Dexamethasone Days 1, 8, 15, 2228-day cycle
(n = 396)
RdLenalidomide Days 1-21 +
Dexamethasone Days 1, 8, 15, 2228-day cycle
(n = 396)
Carfilzomib: 20 mg/m2 Days 1, 2 of cycle 1; 27 mg/m2 thereafter. Lenalidomide: 25 mg. Dexamethasone: 40 mg.
Stewart AK, et al. N Engl J Med. 2015;372:142-152. Slide credit: clinicaloptions.com
18
ASPIRE: PFS
KRd Rd(n = 396) (n = 396)
Median PFS, mos 26.3 17.6HR (KRd/Rd) (95% CI) 0.69 (0.57-0.83)P value (one sided) < .0001
1.0
0.8
0.6
0.4
rtio
n S
urv
ivin
gu
t P
rog
ress
ion
0.2
0
Pro
po
rW
ith
ou
KRdRd
0 6 12 18 24 30 36 42 48Mos Since Randomization
Stewart AK, et al. N Engl J Med. 2015;372:142-152.
Risk Group by FISH
KRd (n = 396) Rd (n = 396) HR P Value
n Median PFS, Mos n Median PFS, Mos
High 48 23.1 52 13.9 0.70 .083
Standard 147 29.6 170 19.5 0.66 .004
Slide credit: clinicaloptions.com
ASPIRE: Adverse Events
Select AEs (All Grades), %[1] KRd (n = 392)
Rd (n = 389)
Nonhematologic AEs occurring in ≥25% of pts Diarrhea 42.3 33.7 Fatigue 32.9 30.6 Cough 28.8 17.2 Pyrexia 28.6 20.8
Upper respiratory tract infection 28.6 19.3
Hypokalemia 27.6 13.4
Implications[2]
Monitor blood counts
Monitor for infection
Cardiac
– EKG for pts with cardiac history, ECHO baselineyp
Muscle spasms 26.5 21.1Hematologic AEs occurring in ≥ 25% of pts Anemia 42.6 39.8 Neutropenia 37.8 33.7 Thrombocytopenia 29.1 22.6
Other AEs of Interest Dyspnea 19.4 14.9 Peripheral neuropathy 17.1 17.0 Hypertension 14.3 6.9 Acute renal failure 8.4 7.2 Cardiac failure 6.4 4.1 Ischemic heart disease 5.9 4.6
– Diuretics, inhalers, minimize fluids, longer infusion time (30 mins)
Advise pts on
– Shortness of breath (dyspnea)
– Fatigue
– Cytopenias
– Infection prevention
– VTE prophylaxis1. Stewart AK, et al. N Engl J Med. 2015;372:142-152.2. Carfilzomib [package insert]. 2016. Slide credit: clinicaloptions.com
PANORAMA1: Bortezomib/Dex ±Panobinostat in RRMM—Study Design
Randomized, multicenter, placebo-controlled, double-blind phase III trial
Pts with
Panobinostat 20 mg Days 1, 3, 5 of Wks 1, 2
Stratified by prior lines of therapy and prior bortezomib
Panobinostat 20 mg Days 1 3 5 of Wks 1 2 4 5
Phase I: Eight 3-wk cycles Phase II: Four 6-wk cycles
Pts with symptomatic
RRMM after 1-3 prior treatments
(bortezomib-refractory excluded)(N = 768)
g yBortezomib
1.3 mg/m2 IV Days 1, 4 of Wks 1, 2Dexamethasone
20 mg Days 1, 2, 4, 5 of Wks 1, 2(n = 387)
Placebo Days 1, 3, 5 of Wks 1,2
Bortezomib 1.3 mg/m2 IV Days 1, 4 of Wks 1, 2
Dexamethasone 20 mg Days 1, 2, 4, 5 of Wks 1, 2
(n = 381)
San-Miguel JF, et al. Lancet Oncol. 2014;15:1195-1206.
20 mg Days 1, 3, 5 of Wks 1, 2, 4, 5Bortezomib
1.3 mg/m2 IV Day 1 of Wks 1, 2, 4, 5Dexamethasone
20 mg Days 1, 2 of Wks 1, 2, 4, 5
Placebo Days 1,3,5 of Wks 1, 2, 4, 5
Bortezomib 1.3 mg/m2 IV Day 1 of Wks 1, 2, 4, 5
Dexamethasone 20 mg Day 1 of Wks 1, 2, 4, 5
≥ SD
≥ SD
Slide credit: clinicaloptions.com
19
PANORAMA1: PFS
Significant improvement in PFS with addition of panobinostat to bortezomib and dexamethasone
100
80
Panobinostat, bortezomib, and dexamethasonePlacebo, bortezomib, and dexamethasone
San-Miguel JF, et al. Lancet Oncol. 2014;15:1195-1206.
80
60
40
20
0
PF
S (
%)
Mos0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36
, ,
HR: 0.63 (95% CI: 0.52-0.76; P < .0001)
Slide credit: clinicaloptions.com
PANORAMA 1: Safety
Select AEs (≥ 10% Incidence and ≥ 5% Greater Incidence With Pan), %
Pan + Bort/Dex (n = 381) Pbo + Bort/Dex (n = 377)
All Grades Grade 3/4 All Grades Grade 3/4
Arrhythmia 12 3 5 2
Diarrhea 68 25 42 8
Nausea 36 6 21 1
Vomiting 26 7 13 1
Fatigue 60 25 42 12
Cardiac
GI
Evaluate and treat diarrhea, fatigue. Watch for myelosuppression, PN with bortezomib
Richardson P, et al. ASCO 2014. Abstract 8510^. San-Miguel JF, et al. Lancet Oncol. 2014;15:1195-1206.
Peripheral edema 29 2 19 <1
Pyrexia 26 1 15 2
Weight loss 12 2 5 1
Decreased appetite 28 3 12 1
Thrombocytopenia 97 67 83 31
Anemia 62 18 52 19
Neutropenia 75 34 36 11
Leukopenia 81 23 48 8
Lymphopenia 82 53 74 40
Other
Heme
Slide credit: clinicaloptions.com
GI events, fatigue, and prolonged QT-C interval are major concerns
Panobinostat + Bortezomib/dex: Dose and Schedule
Novel Agents in MM Cycles 1-8 (28-Day Cycles)
Wk 1 Wk 2
D 1
D 2
D 3
D 4
D 5
D 6
D 7
D 1
D 2
D 3
D 4
D 5
D 6
D 7
Panobinostat20 mg PO
Bortezomib co ce s
Alternate dosing can be confusing
Bortezomib1.3 mg/m2
Dexamethasone20 mg PO
Panobinostat PI. 2015.
Cycles 9-16 (28-Day Cycles)
Wk 1 Wk 2
D 1
D 2
D 3
D 4
D 5
D 6
D 7
D 1
D 2
D 3
D 4
D 5
D 6
D 7
Panobinostat
Bortezomib
Dexamethasone
Slide credit: clinicaloptions.com
20
TOURMALINE-MM1: Rd ± Ixazomib— PFS
Phase III trial (N = 722) in R/R MM and 1-3 prior Tx
Addition of ixazomib to Rd resulted in 35% improvement in PFS vs Rd alone100
80
Median PFS:IRd: 20.6 mosPlacebo-Rd: 14.7 mos
FS
(%
)
PFS benefit with ixazomib seen in all prespecified subgroups, including cytogenetic high risk, PI and IMiD exposed
Moreau P, et al. ASH 2015. Abstract 727. Slide credit: clinicaloptions.com
60
40
20
0
Log-rank P = .012HR (95% CI): 0.742 (0.587-0.939)Number of events: IRD 129; placebo-Rd 157
0 2 4 6 8 10 12 14 16 18 20 22 24Mos From Randomization
Pro
bab
ilit
y o
f P
F
TOURMALINE-MM1: Response
CharacteristicIxazomib + Rd
(n = 360)Placebo + Rd
(n = 362)P Value
ORR, % CR VGPR PR
78.311.736.466.7
71.56.6
32.364.9
.035
.019
Moreau P, et al. ASH 2015. Abstract 727.
Median time to response, mos 1.1 1.9
Median DoR, mos 20.5 15.0
Median TTP, mos 21.4 15.7 .007*
*HR: 0.712.
Slide credit: clinicaloptions.com
TOURMALINE-MM1: Safety
AE, %Ixazomib + Rd (n = 361) Placebo + Rd (n = 359)
Any Grade Grade 3/4 Any Grade Grade 3/4
AEs attributed to ixazomib and/or lenalidomide
Diarrhea Constipation Nausea Vomiting Rash
4535292336
6< 1215
3926221223
3< 10
< 12
Moreau P, et al. ASH 2015. Abstract 727.
Rash Back pain Upper respiratory infection Thrombocytopenia
36242331
5< 1< 119
23171916
2309
AEs attributed to ixazomib
Peripheral neuropathy Peripheral edema
2728
21
2220
00
AEs attributed to lenalidomide
Thromboembolism Neutropenia
833
< 323
1131
< 424
Slide credit: clinicaloptions.com
21
Ixazomib + Rd: Dose and Schedule
28-Day Cycles
Wk 1 Wk 2 Wk 3 Wk 4
Day 1Days 2-7
Day 8
Days 9-14
Day 15
Days 16-21
Day22
Days 23-28
Ixazomib 4 mg PO
Ixazomib [package insert]. 2015. Slide credit: clinicaloptions.com
Ixazomib implications:
Dose reduce for hepatic impairment
Nausea, rash, and thrombocytopenia can occur
HSV prophylaxis
Rapidly absorbed
Lenalidomide 20 mg PO
QD QD QD
Dexamethasone40 mg PO
ELOQUENT-2: Safety
AE, %Elotuzumab + Len/Dex
(n = 318)Len/Dex(n = 317)
Hematologic (grade ≥ 3) Anemia Neutropenia
1526
1633
Nonhematologic (grade ≥ 3) Fatigue 9 8
Infusion reactions experienced by 10% of pts; most were grade 1/2 and occurred during first treatment cycle
Dimopoulos MA, et al. ASH 2015. Abstract 28. Slide credit: clinicaloptions.com
Fatigue Diarrhea Pyrexia
953
853
GI disorders (any grade) 81 68
Respiratory disorders (any grade) 63 53
Renal/urinary (any grade) 25 18
Peripheral neuropathy (any grade) 15 9
SIRIUS: Study Design
Open-label, international, multicenter, 2-stage study
Pts with MM who had recei ed ≥ 3 prior lines of
Daratumumab 8 mg/kg q4w
(n = 18)
Stage 1 Response assessment Stage 2
Enrollment of additional pts at 16 mg/kg dose
(outcomes reported for all pts at 16 mg/mg dose)
Primary objective:ORR
Secondary objectives: PFS, OS, duration of response, time to response, clinical benefit rate
Lonial S, et al. ASCO 2015. Abstract LBA8512.
received ≥ 3 prior lines of therapy or were
refractory to a PI and an IMiD
(N = 53)
(n 18)
Daratumumab 16 mg/kgqw x 8 then q2w x 16,
then q4w thereafter(n = 16)
Daratumumab 16 mg/kgqw x 8 then q2w x 16,
then q4w thereafter(n = 90)
Slide credit: clinicaloptions.com
Recommended