Updates in the Management of Myeloma:
New Treatments on the Horizon
Accredited by Medical Education Resources
Supported by The International Myeloma Foundation
Grant Funding provided by
Celgene Corporation
Millennium: The Takeda Oncology Company
and Onyx Pharmaceuticals
Beth Faiman MSN, APRN, BC, AOCN®
Pre-Doctoral Research Fellow,
Francis Payne Bolton School of Nursing at Case
Western Reserve
Nurse Practitioner, Taussig Cancer Institute
Cleveland Clinic Foundation
Cleveland , Ohio
Learning Objectives:
Venous Thromboembolism and Peripheral
Neuropathy
Review the main coagulopathies in MM and their pathophysiology
Identify the indication for and types of thromboprophyllaxis used
in MM
Identify nursing interventions for prompt diagnosis and early
treatment of coagulopathy in MM
Review therapies in MM that can cause PN and coagulopathies
List nursing interventions to decrease PN and coagulopathies
Name 2 new agents to treat MM
What is Multiple Myeloma?
· Cancer of plasma cells
· Healthy plasma cells produce antibodies
or immunoglobulins
· Part of our humoral immunity, they are released in
response to foreign body invasion
· Myeloma cells produce abnormal
immunoglobulin
· Overproduce monoclonal protein or paraprotein
· Ineffective immunoglobulins
· Leads to decreased bone marrow function
· Destruction of bone tissue, organ dysfunction
San Miguel JF, et al. Pathogenesis of Multiple Myeloma: Rationale for New and Novel Therapies. Clinical Care Options: Accessed 22 February, 2007.
http://clinicaloptions.com/Oncology/Treatment%20Updates/Myeloma/Modules/Pathophysiology/Pages/Page%203.aspx.
Criteria for Diagnosis of
Multiple Myeloma
Monoclonal plasma cells present in the bone
marrow 10%, and/or presence of a documented
plasmacytoma
+
Presence of M component in serum and/or urine*
+
One or more of the following (CRAB criteria)
· Calcium elevation (serum calcium >11.5 mg/dL)
· Renal insufficiency (serum creatinine >2 mg/dL)
· Anemia (hemoglobin <10 g/dL or 2 g/dL <normal)
· Bone disease (lytic lesions or osteopenia)
*Monoclonal M spike on electrophoresis IgG>3.5g/dL, IgA>2g/dL, light chain >1g/dL in 24-hr urine sample
Durie et al for the International Myeloma Working Group. Leukemia. 2006:1-7.
MM Treatment Options
Conventional chemotherapy:
·
Melphalan
·
Doxorubicin
·
Cyclophosphamide
Maintenance in MM
Steroid therapy:
·After transplant
· Dexamethasone
·Conventional therapy
· Prednisone
Novel therapeutics:
**NEW TREATMENTS**
·
Thalidomide
·
Lenalidomide
·
Bortezomib
Stem cell transplantation:
·
Autologous
·
Allogeneic
Radiation therapy
Thalomid ® Prescribing Information, lenalidomide ® Prescribing
Information; bortezomib® Prescribing Information
Nurse Centric Model of Patient Care*
Patient Monitoring
Patient Management
Patient Counseling
Patient Research
Nurses are Central to
Patient Management and
Healthcare Resource
Coordination
Patient Advocacy
Patient Education
* Developed by ScienceFirst, LLC; All Rights Reserved (www.science-first.com)
Completion of `Consensus Statements'
Five consensus statements on the management of side
effects associated with the novel therapeutic agents used
in treating multiple myeloma patients
1.
Deep Vein Thrombosis / Pulmonary Embolism
2.
Peripheral Neuropathy
3.
Steroids Related Side Effects
4.
Myelosuppression
5.
Gastrointestinal Effects
IMF-NLB `Consensus Statements' supplement In Press, CJON June 2008
Novel Therapies:
Mechanisms of Action (MOA)
· Thalidomide
Immunomodulatory, anti-inflammatory, and anti-angiogenic agent
Suppresses production of TNF-, IL-6, and other cytokines
· Lenalidomide
Immunomodulatory agent with anti-angiogenic and anti-neoplastic
properties
Inhibits the secretion of pro-inflammatory cytokines and increases
the secretion of anti-inflammatory cytokines
· Bortezomib
The first drug in the class of "proteasome inhibitors"
A reversible inhibitor of 26S proteasome complex
Influences apoptotic, cell adhesion, and angiogenic pathways
· Doxil®
Used in combination with bortezomib®
Reformulated version of the chemotherapeutic agent doxorubicin
Pegylated liposomal delivery
» Decreased immunoreactivity
» Increased bioavailability
thalidomide ® Prescribing Information, lenalidomide ® Prescribing Information
Velcade® Prescribing Information
Overview of Thromboembolic Events (TE)
`Consensus Statement'
Cancer patients have a higher risk of TE events (7-10 fold) which
may lead to:
·
Deep vein thrombosis (DVT)
·
Pulmonary embolism (PE)
MM patients are at an increased risk for blood clots
·
Patients are at increased risk with high dose dexamethasone
treatment
·
The risk for DVT/PE is further increased in patients treated with
novel therapies
Thalidomide
Lenalidomide
·
In patients age >65 years 5% increase chance to develop TE
Measures to prevent novel therapy-associated TE events include:
·
Mechanical
·
Myeloma regimen-related
·
Anticoagulant therapy (clot-preventing)
Individual and disease related risk factors must be assessed in
ALL patients with MM
TE events are serious and potentially life-altering and life-threatening
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008. Amir Qaseem et al., 2007, Ann Fam Med; J. B. Segal et al., 2007, Ann
Intern Med. http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_WhoIsAtRisk.htm
PE - Signs/Symptoms
· Anxiety
· Sudden dyspnea
· Chest discomfort-increase w/ breathing
· Tachycardia, tachypnea
· Low grade fever, + Homans (35%)
· Pleural friction rub, crackles followed by
diminished breath sounds, wheezing
· ECG right axis deviation or new RBBB
PE is a Medical Emergency
http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_SignsAndSymptoms.html
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008
TE Event - Diagnostics
DVT
PE
· Doppler Ultrasound
·Ventilation Perfusion lung
(VQ) Scan
· Contrast Venography
·Spiral CT Scan
· D-Dimer
·D-Dimer
· Antithrombin Level
·Antithrombin Level
http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_Diagnosis.html
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008
TE Event - Prophylaxis
Mechanical
·
Sequential Compression Devices
·
Anti-embolism Stockings
·
Exercise Regimen
Pharmaceuticals - Therapy Dose Reductions
·
Thalidomide: by 50mg increments from current dose
·
Dexamethasone
· 20- 40mg once weekly
· 20- 40mg days 1- 4 on 28d cycle
http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_Treatments.htm; Adapted from NLB Consensus Recommendations; In Press, CJON June 2008
thalidomide® Prescribing Information; Dexamethasone Prescribing Information
Thromboembolic Events - Prophylaxis
Pharmaceutical
Agent
Suggested Dose
Salicylic Acid (aspirin)
SD 325mg or LD 81mg Daily
Unfractionated Heparin
5000 IU sq bid
Low Molecular Weight Heparin
- enoxaparin
40mg sq daily
-dalteparin
200IU/kg sc daily
Arixtra® fondaparinux
2.5mg sc daily
Warfarin
Weight based
· 1mg < 70kg
· 2mg 70kg
Prophylaxis tailored to individual patient's risk profile in consideration of
the International Myeloma Working Group consensus statement*
Palumbo et al., Leukemia (In press); Adapted from NLB Consensus Recommendations. In Press, CJON June 2008.
Amir Qaseem et al., 2007, Ann Fam Med; J. B. Segal et al., 2007, Ann Intern Med.
Treatment of VTE
Vena cava filter: Prevents PE with no evidence of
preventing DVT
Sequential compression devices: No bleeding risk,
continuous use, and impairs ambulation
Compression stockings: Little to no evidence of
effectiveness, possible adverse effects in patients
with cancer
INR = international normalized ratio.
NCCN, 2008; Arixtra® prescribing information, 2008.
General Strategic Recommendations for the
Management of TE Events
Prophylactic measures which can reduce or eliminate
TE risk (especially in the first 3-6 mos) include:
· Aspirin; suggested for patients with no or one risk
factor
· Low molecular weight heparin or full dose warfarin for
patients with two or more risk factors
· Low molecular weight heparin or full dose warfarin for
all patients with therapy-related risks including:
High dose dexamethasone
Doxorubicin
Multi-agent chemotherapy
Renal disease
ESAs
Obesity
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008
http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_Treatments.html
Overview of Peripheral Neuropathy (PN)
`Consensus Statement'
· Anti-myeloma therapies can lead to PN
· PN is a challenging adverse event which may:
· Affect quality of life
· Compromise optimal treatment
· Management strategies include:
· Ongoing evaluation
· Dose and schedule modifications
· Pharmacologic interventions
· Non-pharmacologic approaches
· Patient education
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008, thalidomide® Prescribing Information, bortezomib® Prescribing Informati
Colson et al., 2004, Clinical Journal of Oncology Nursing; S. Lonial, 2007, The American Journal of Hematology/Oncology.
Peripheral Neuropathy (PN):
General Concepts
Patients with MM are at risk for PN based on the biology of the disease
PN can lead to structural damage in the peripheral nerves of the central
nervous system
"Stocking-glove" distribution
Sensory component of neuropathy has 2 primary types
· Small fiber: Pin-prick, pain and temperature
· Large fiber: Vibration and proprioception
CIPN = chemotherapy-induced peripheral neuropathy.
Armstrong et al, 2005. Ropper & Gorson, 1998
PN Definition, Signs/Symptoms
Damage to the peripheral nervous system including any injury,
inflammation, or degeneration of peripheral nerve fibers
Signs/symptoms
Severe symptoms
· Temporary Numbness
· Burning Pain
· Tingling
· Muscle Wasting
· Parasthesias
· Paralysis
· Sensitivity to Touch
· Organ Dysfunction
· Muscle Weakness
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008
http://www.ninds.nih.gov/disorders/peripheralneuropathy/detail_peripheralneuropathy.htm
Factors Contributing to CIPN
·
Older age
·
Chemotherapy dose, cumulative dose
·
Prior cisplatin or vinca alkaloids
·
Therapy duration
·
Co-administration of other neurotoxic agents
·
Pre-existing conditions such as diabetes, alcoholism, HIV
positive, female gender, Vit B12 deficiency
·
AL amyloidosis
Wickham, 2007
Novel Agents Associated
With PN in MM
Agent
Incidence
Bortezomib
· Grade 1/2 occur in ~ 75% with recurrent disease; 33%
with newly diagnosed
· In a Phase II trial of bortezomib in relapsed MM, 81%
previously treated had PN (regardless of prior therapy)
Thalidomide
· Grade 1/2 PN occurs in 80% pts previously treated
·Grade 3/4 PN can occur in ~ 4% when combined with
dexamethasone; all grades 53.9% when combined with
dexamethasone
Chemo: Cisplatin and Vincristine Rarely used
Badros et al, 2007; Argyriou, Iconomou, et al, 2008; Jagannath et al, 2005; Gupta et al, 2006; Thomas et al, 2007; Buzdar, 2008;
Argyriou, Koltzenburgh, et al, 2008; Chan et al, 1999; Thalomid® prescribing information, 2007.
PN and Pain Toxicity Grades
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Mild
Moderate
Severe
Life-threatening or
Death
disabling
Mild pain not
Moderate pain
Severe pain
Disabling
N/A
interfering with
interfering with function
severely
function
but not ADL
interfering with
ADL
Asymptomatic,
Symptomatic weakness
Weakness
Life-threatening
Death
weakness on
interfering with function
interfering with
disabling
testing only
but not ADL
ADL
Asymptomatic,
Sensory alteration or
Sensory
Disabling
Death
loss of deep
paresthesias interfering
alteration or
tendon reflexes or
with function not with
paresthesias
paresthesias
ADL
interfering with
ADL
Grading based upon:
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
http://ctep.cancer.gov/forms/CTCAEv3.pdf
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008
PN: FACT-GOG Neurotoxicity Assessment Tool
Instructions for Patients
Instructions for Healthcare Professionals
By circling one number per line, please indicate how true each
This assessment tool is provided to help you
statement has been for you during the past seven days, using the
evaluate peripheral neuropathy in patients receiving
following scale:
chemotherapy. Healthcare professionals may find
discussion of patients' responses helpful in
0 = not at all
determining the grade of neuropathy as defined by
1 = a little bit
the National Cancer Institute Common Terminology
2 = somewhat
Criteria for Adverse Events; however, no direct
3 = quite a bit
correlation exists between assessment scores and
4 = very much
toxicity grades.
I have numbness or tingling in my hands.
0
1
2
3
4
I have numbness or tingling in my feet.
0
1
2
3
4
I feel discomfort in my hands.
0
1
2
3
4
I feel discomfort in my feet.
0
1
2
3
4
.
I have joint pain or muscle cramps.
0
1
2
3
4
I feel weak all over.
0
1
2
3
4
I have trouble hearing.
0
1
2
3
4
I get a ringing or buzzing in my ears.
0
1
2
3
4
I have trouble buttoning buttons.
0
1
2
3
4
I have trouble feeling the shape of small objects when they are in my hands.
0
1
2
3
4
I have trouble walking.
0
1
2
3
4
Calhoun, et al. Proceedings of the American Society of Clinical Oncology 2000.; Cella, 1997;Cella, et al. Journal of Clinical
22
Oncology 1993.; http://ctep.cancer.gov
PN Dose/Schedule Modifications
Bortezomib Therapy
·
Currently, dose modification of bortezomib and
thalidomide is the most effective management
strategy
·
Grade 1 with pain or Grade 2: Reduce dose to 1
mg/m2
·
Grade 3 or Severe: Hold therapy PN resolves
to baseline
· Restart at 0.7 mg/m2
· Consider changing treatment to once weekly
·
Grade 4: D/C therapy
Velcade® Prescribing Information; http://ctep.cancer.gov/forms/CTCAEv3.pdf; Adapted from NLB Consensus Recommendations. In Press, CJON 2008; ACS, 2005; Armstrong et al, 2005,
Oncology Nursing Forum; Colson et al., 2004, Clinical Journal of Oncology Nursing; NCCN 2007; NINDS, 2007; Tariman, 2003, Clinical Journal of Oncology Nursing; Visovsky et al., 2007,
http://www.ons.org/outcomes/volume2/peripheral/pdf/PEPCardDet_peripheral.pdf
PN Dose/Schedule Modifications
(cont'd)
Thalidomide Therapy
Grade 1 or Mild:
· Continue therapy
Grade 2 or Moderate:
· Intermittent Continue therapy
· Continuous Stop therapy and observe whether
symptoms persist
· If symptoms resolve Restart therapy at a reduced dose
Grade 3 or Severe:
· Hold therapy until PN resolves to baseline
· Once symptoms resolve Restart therapy at a reduced dose
Grade 4 or Disabling:
· Discontinue therapy permanently
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008; thalidomide® Prescribing Information;
http://ctep.cancer.gov/forms/CTCAEv3.pdf; Colson et al., 2004, Clinical Journal of Oncology Nursing; NCCN 2007; NINDS, 2007; Tariman, 2003, Clinical Journal of Oncology Nursing;
Visovsky et al., 2007, http://www.ons.org/outcomes/volume2/peripheral/pdf/PEPCardDet_peripheral.pdf.
Bortezomib/Melphalan/Prednisone/Thalidomide
Bortezomib/Thalidomide
A Phase III Study of VMPT Followed by Maintenance with Bortezomib and Thalidomide
for Initial Treatment of Elderly Multiple Myeloma Patients
Study Objective:
·
Compare VMPT with a maintenance regimen including Bortezomib and Thalidomide
with VMP without a maintenance regimen
Study Design:
·
Prospective, randomized
Bortezomib
1.3 mg/m2 Melphalan
9 mg/m2
Days 14
Bortezomib
1.3 mg/m2
Days 1, 15
Prednisone
60 mg/m2
Days 14
Thalidomide 50 mg/day
continuously
Thalidomide 50 mg
Days 142
Bortezomib 1.3 mg/m2 Melphalan
9 mg/m2
Days 14
No Maintenance
Prednisone
60 mg/m2
Days 14
·
Both regimens amended to 9 5-week cycles
·
Bortezomib modified to weekly administration (days 1,8,15,22)
25
Palumbo et al, Blood 114, Abstract 128, 2009
Conclusions from VMPT VT vs. VMP
Study Arm
PR, %
VGPR, %
CR, %
2Y PFS, %
2Y OS, %
VMPT-VT
86
55
34
70
89.6
VMP
79
47
21
58.2
89.0
p-Value
0.02
0.07
0.0008
0.0008
0.84
VMPT followed by VT was superior to VMP for response rates and PFS
The weekly infusion of Bortezomib significantly reduced the incidence of grade 3-4 peripheral
neuropathy
·
From 18% to 4% (p=0.0002) in VMPT arm
·
From 13% to 2% (p=0.0003) in VMP arm
This is the first report showing the superiority of a 4-drug regimen followed by maintenance
compared to standard therapy (VMP)
Weekly infusion of bortezomib effective and less PN
26
Palumbo et al, Blood 114, Abstract 128, 2009
A Phase 3 Prospective Randomized International Study (MMY-
3021) Comparing Subcutaneous and Intravenous Administration
of Bortezomib In Patients with Relapsed MM
Patients with MM may have poor IV access especially if
previously treated
222 patients from 53 centers in 10 countries
participated in this study and randomized to SC (148)
or IV (74).
** Concentration is different from IV bortezomib
(2.5 mg/ml) **
Moreau et al., 2010
A Phase 3 Prospective Randomized International Study (MMY-3021)
Comparing Subcutaneous (SC) and Intravenous (IV) Administration of
Bortezomib In Patients with Relapsed MM
222 patients from 53 centers in 10 countries
· Randomized to SC (148) or IV (74).
The data highlight the efficacy of bortezomib irrespective of its
route of administration.
· Median PFS 10.2 mos SC arm vs 8.0 mos in the IV arm
· 1yr OS 72.6% in the SC group and 76.7% IV.
Less toxicity with SC
· Less peripheral neuropathy (PN) (38% SC vs. 53% IV),
· Less grade 3 and higher PN (6% SC vs. 16% IV), and
· Less gastrointestinal disorders (37% SC vs. 58%IV)
Moreau et al., 2010
General Strategic Recommendations for
the Management of PN
Patient Education
· Notify if S/S Worsen
· Home safety with decreased sensation in extremities
· Is driving appropriate?
· Family members to assess hot/cold temperatures if
patient is unable to do so
Non-Pharmaceutical
· Gentle massage of affected areas with cocoa butter,
capsaicin cream
· Home Health Referral to review safety at home
· Assistance with ADL
· Referrals: Pain management, neurology,
physical/occupational therapy
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008; NCCN 2007; NINDS, 2007; Tariman, 2003,
Clinical Journal of Oncology Nursing; Visovsky et al., 2007, http://www.ons.org/outcomes/volume2/peripheral/pdf/PEPCardDet_peripheral.pdf.
General Strategic Recommendations for
the Management of PN (cont'd)
For all patients prior to therapy
·
B-complex vitamins including B1, B6, B12 (at least 400 mcg)
·
Folic Acid 1 mg daily
For grades 2 or higher
·
Tricyclic antidepressants (i.e. amitriptyline, despiramine)
·
Try Amino Acids (eg, acetyl L-carnitine, L-glutamine and alpha
lipoic acid) on an empty stomach
·
Neurontin®, Lyrica®, Cymbalta®
·
May apply Lidoderm® Patch 5% to affected area every 12 hours
Adapted from NLB Consensus Recommendations. In Press, CJON June 2008, Colson et al., 2004, Clinical Journal of Oncology Nursing; NCCN 2007; NINDS, 2007; Tariman, 2003, Clinical
Journal of Oncology Nursing; Visovsky et al., 2007, http://www.ons.org/outcomes/volume2/peripheral/pdf/PEPCardDet_peripheral.pdf; Endo Pharmaceuticals; 2006; Lidoderm® (lidocaine
patch 5%) prescribing information; http://www.mayoclinic.com/health/peripheral-neuropathy/BN00046
Upcoming Promising Approaches
Novel single agents
· Carfilzomib
· Pomalidomide
Other Exciting New combination regimens
· Bortezomib + siltuximab /vorinostat /panobinostat /
tanespimycin /perifosine
· Bortezomib/PLD + vorinostat
· Carfilzomib + len/dex
· Lenalidomide/dex + vorinostat /-CS-1/ thalidomide
Single-Agent Carfilzomib (CFZ) in Patients With Relapsed
or Refractory Myeloma (MM
Vij R, et al. ASCO 2010. Abstract 8000.
Responses
Siegel D, et al. ASH 2009. Abstract 303.
Time to Progression
Siegel D, et al. ASH 2009. Abstract 303.
Adverse Events
Siegel D, et al. ASH 2009. Abstract 303.
Neuropathy
Siegel D, et al. ASH 2009. Abstract 303.
Vij R, et al. ASCO 2010. Abstract 8000.
Carfilzomib Plus Lenalidomide and Low-Dose
Dexamethasone (CRd) in Relapsed and Refractory
Multiple Myeloma (MM
· Multi-center phase Ib study
· Patients with 1-3 prior lines of therapy
and relapsed multiple myeloma
· Cycles q 28 days
Niesvizky R, et al. ASH 2009. Abstract 304.
Prior Therapies
Niesvizky R, et al. ASH 2009. Abstract 304.
Adverse Events
· No DLTs or
grade 5
toxicities
through first 5
cohorts (N =
27)
· No fatigue
grade 3 or
thrombotic
events
Niesvizky R, et al. ASH 2009. Abstract 304.
Activity
· All responses seen at <MTD; 29/32 pts evaluable
· Cohort 6 will use carfilzomib at 27 mg/m2 in cycle
2
Niesvizky R, et al. ASH 2009. Abstract 304.
Elotuzumab
Elotuzumab is a humanized monoclonal IgG1 antibody directed
against CS1, an antigen highly and uniformly expressed on
multiple myeloma (MM) cells but with restricted expression
on normal cells
· Elotuzumab In Combination with Lenalidomide and
Dexamethasone In Patients with RRMM: Interim Results of a
Phase 2 Study
Generally well tolerated with 84% objective response)
· Elotuzumab In Combination with Bortezomib In Patients with
RRMM: Phase I
Generally well tolerated with 48% objective response)
Richardson et al, Abstract 986, 2010
Jakubowiak et al., Abstract #3023, 2010
Phase 1/2 Pomalidomide
Phase 1 (MTD)
Dose
Discontinue
2 mg
POM therapy
Progressive disease (PD)
and follow-up
3 mg
Option to add
PD
for survival
(QD on days 1-21 of
low-dose dex
4 mg
or no response after
and
a 28-day cycle)
(40 mg/wk)
5 mg
completion of 4 cycles
subsequent
treatment
Phase 2 (Open Label)
Arm A
PD
Discontinue
POM (4 mg)
and follow-up
TION
+ low-dose dex
for survival
and
subsequent
treatment
PD
Option to add
Arm B
low-dose dex
POM (4 mg)
RANDOMIZA
(40 mg/wk)
Richardson P, et al. ASH 2009. Abstract 301.
Safety Profile
POM Dose
2 mg
3 mg
4 mg
5 mg
Adverse event, n
(n = 6)
(n = 8)
(n = 8)
(n = 10)
Neutropeniaa
88
7
9
Thrombocytopeniaa
26
0
0
Anemiaa
27
2
0
VTE
1 (G2)
0
0
1 (G3)
Treatment-emergent SAEs
7
7
4
4
Deathsb
21
1
0
POM dose reduction
0
1
0
9
SAEs, severe adverse events; VTE, venous thromboembolism.
a. Grade 3/4; b. Includes deaths occurring at least 28d after last treatment (both due to rapid PD).
Richardson P, et al. ASH 2009. Abstract 301.
Best Responses
POM Dose
Best Responsea[1]
(± Dex)
2 mg (n = 6)
1 PR, 1 SD, 1 PD, 3 NE
3 mg (n = 8)
1 CR, 1 MR, 5 SD, 1 NE
4 mg (n = 8)
2 PR, 3 MR, 1 SD, 2 NE
5 mg (n = 10)
3 PR, 2 MR, 3 SD, 1 PD, 1 NE
CR, complete response; MR, minimal response; NE, not evaluable; PD, progressive disease;
PR, partial response; SD, stable disease. a. As measured using modified EBMT criteria[2,3] every 28d.
· 7/25 evaluable pts (28%) PR; 13/25 pts (52%) MR[4]
· 15 pts received dex in addition to POM for either lack of
response or PD; 8/15 pts (53%) improved response after dex
added, with durability of response also improved from 13.5 to
16.9 wks[1]
1. Richardson P, et al. ASH 2009. Abstract 301. 2. Bladé J, et al. Br J Haematol. 1998;102:1115-1123. 3.
Richardson PG, et al. N Engl J Med. 2003;348:2609-2617. 4. Anderson KC, et al. Leukemia. 2008;22:231-239.
Impact of Novel Agents at Relapse
1.0
Relapsed before 1998
Relapsed 19981999
0.8
Relapsed 20002001
Relapsed 20022003
Relapsed 20042005
0.6
0.4
Survival
0.2
P<0.001
0.0
0
20
40
60
80
100
Time From After ASCT Relapse (Months)
Kumar, S et al. Blood 111:2516-2520, 2008.
Summary
·Nurses are integral to management of patients
·Patients will be more likely to adhere to the prescribed
regimen if side effects are appropriately addressed and
manage
·Never underestimate your role as a provider and
liason!
·More to come from NLB.... SURVIVORSHIP!
Educational Resources
·
International Myeloma Foundation
·
Myeloma Today Newsletter
·
Hotline: 1-800-452-CURE (2873)
·
Website: http://myeloma.org
·
American Cancer Society
·
National Cancer Institute
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·
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A statement off
f credit will be issued only upon receipt of a completed
activity form and a completed posttest with a score of 70% or better.
Statements of credit will be mailed within 6 weeks of the activity.
ACCREDITATION
·
This continuing education activity provides a maximum of 1.0
tt
contact hours f
o R
i
eg stered Nursing C d
re it
dit
·
Medical Education Resources is an approved provider of
continuing nursing education by the California Board of
Registered Nursing, Provider #CEP 12299.
·
Please email Diane Moran at the International Myeloma
Foundation if you have any
yy questions.
q
dmoran@myeloma.org
· Thank you!