Update on
Novel
Therapies
Bonnie Jenkins, RN
University of Arkansas for Medical Sciences
Myeloma Institute for Research and Therapy
Little Rock Arkansas
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Subcutaneous Administration
VELCADE!!!
· After 12 weeks of treatment with single agent Velcade,
Response rate same in SQ or IV
· 63% Reduction in Severe Peripheral Neuropathy
· Adverse events of grade 3 or higher
IV arm: 70%
SQ arm: 27%
· severe peripheral neuropathy was much less frequent
with weekly dosing (8% compared with 28% with twice-
weekly dosing).
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Should I Ask to Change?
· The decision must be between you and your
physician.
· New stuff! Give it a little time.
· This is generally for established patients. If you
are a new patient with a heavy tumor burden you
may start with IV and change later.
It does take longer to get into the system, although at 12
weeks there were no differences in effectiveness.
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How Do I Decide to
Change?
· Across the board, patients feel increased
convenience
· Excellent for Maintenance Phases
· The distant future might allow for home
administration of the drug in Maintenance with
substantial cost reduction and greatly improved
patient convenience.
But the FDA isn't ready for this, nor is HHS.
· This is your cue to get involved to change things
with advocacy.
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2
Peripheral Neuropathy:
Anyone have anything new?
· Remember the most likely causes:
· Myeloma
· Chemotherapy : CIPN
· Diabetes
· Shingles
· Vitamin deficiency
· Alcoholism
· Autoimmune Diseases
· Amyloid
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CIPN: Chemotherapy-Induced
Peripheral Neuropathy
· Recent literature insufficient evidence was found
to recommend any non-pharmacologic or
pharmacologic interventions.
· Evidence is mounting for the merits of physical
activity in preventing and managing side effects but
its role in maintenance or recovery of CIPN has not
yet been demonstrated.
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3
CIPN: Diagnostic Tests
· Nerve Conduction Studies/Electromyography
(EMG): measures sensory and motor conduction.
Insensitive in acute and small fiber neuropathy.
· Quantitative Sensory Test: detects sensory
thresholds for migration, heat, pain.
· Skin Biopsy: IENFD (Intraepidermal nerve fiber
density) enables a direct study of small nerve fibers
· These may help in distinguishing medication-
induced from other causes.
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CIPN: So What Do We Do?
· You should be evaluated before, during and
after the chemo regimen.
· Consider physical therapy as an on-going
personal commitment.
· Anecdotal remedies are still the main-stay of
treatments: Support Group Conversations!
· Try more than one approach: Neurontin, Vitamin
B6, magnesium supplements, Alpha Lipoic Acid,
Vitamin E, Amino Acids, Lidocaine Patches, Lyrica,
Cymbalta, tricyclic antidepressants...
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4
CIPN:
Nutritional Management
· Used to increase the oxide synthesis and may offer
the potential advantage of improving blood flow to
the peripheral nerves and thereby reducing
symptoms
· A Medical Food Complex call Metanx helps to
convert arginine into nitric oxide.
The nitric oxide is diffused into smooth muscle cells, and
smooth muscle dells dilate and blood flow is improved to
the peripheral nerves reducing symptoms.
9
I WILL SURVIVE!
Or what do I do now that I forgot to die?
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5
What is the life-long impact of
out-living myeloma?
11
Bone Disease in Multiple Myeloma
Bone destruction is a hallmark of multiple myeloma.
· Don't stop medical follow-up
because your dz is in remission
· Always clear your meds and
supplements with your MD
·
Osteolysis often present in
Pain management may be a life- multiple myeloma bone
marrow biopsy
long issue... see a specialist
· Learn what constitutes a
symptom that needs immediate
attention.
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Skeletal Events!
Old lesions, New Fractures
Skeletal events may progress despite continued treatment.
· Medical follow-up and lab and imaging may
be needed for a very long time.
· Blood tests for bone disease include
Calcium
Vitamin D
Alkaline phosphatase
Creatinine
Hormone levels such as PTH, testosterone.
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Evidence-Based Recommendations
for Good Bone Health
· Mobility and exercise
· Dietary recommendations and supplements
· Regular assessment of bone disease and bone health
(lab and imaging)
· Radiation treatment
· Surgical interventions and post-surgery care
· Use of bisphosphonates
· Effective pain management
Patients are living longer and getting joint replacements!
14
IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation
7
Functional Mobility and Safety
in Multiple Myeloma
Remember that you are special. You beat the disease every day!
· Multiple myeloma occurs more commonly
in the elderly population
· Bone disease is a major component of
multiple myeloma
· Inherent to this and other risk factors are
issues of mobility and safety.
Up to 1/3 of older adults fall every year
In myeloma, falls often lead to fractures
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Roodman, Leukemia 2008; Roodman, Hem Am Soc Hematol Educ Program 2008; Melton et al, J Bone Miner Res 2004
Risk Factors Affecting
Myeloma Patients
Factors Contributing to High Risk of Falls (ROF):
· Vision
Sensory Issues
· Hearing
· Cardiovascular
· Diabetes
· Osteoporosis
Age-Related
· Hormonal status
Co-Morbidities
· Parkinson's disease
· Dementia
· Urinary incontinence (fall-related)
· Arthritis
· Muscle weakness
Nutrition
· Weight loss
Psychological Issues and Lifestyle
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Gantz et al, J Am Med Assoc 2007
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Functional Mobility and Safety:
· Mobility issues and ROF pose serious challenges to
MM patients.
· MOVE, walk in place,
· keep some momentum going!
· Ask for help to achieve improvements
in functional ability, strength, and
balance to reduce ROF and fall-related
injuries.
· Make a plan; use a support group meeting to invite
a physical therapist to teach some safe, effective
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moves!
IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation
Who's Watching the "Kids"?
· Kidney dysfunction is one of
the common clinical features
of symptomatic MM.
· Between 20% and 60% of MM
patients present with renal
insufficiency or renal failure at
diagnosis or throughout their disease.
It may negatively affect overall
survival and quality of life.
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Tariman and Faiman, in Cancer Nursing Principles and Practice, 2010; Blade et al, Arch Intern Med, 1998
9
PEOPLE Have Kidney
Problems;
it isn't always Myeloma
· Co-morbidities
Diabetes
Cardiovascular disease
Hypertension
Infections
· Hereditary and social factors
Age >60 years
Anemia
Racial or ethnic status
Family history of renal disease
· Treatment side effects
19
Longo & Anderson, K. Plasma cell disorders. In Harrison's principle of internal medicine 2005
Stay Alert: Kidneys are Precious
Renal dysfunction and renal insufficiency are common clinical features
· Early identification of renal issues
· Diagnosis and interventions throughout therapy and
even beyond
· Educational and preventive strategies
· Don't get dehydrated! Enjoy outdoors, but be aware
of heat, perspiration, and exercise!
· Surveillance for chronic kidney disease
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10
Can We Talk?
Time to have the SEX talk!!
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Sexual Dysfunction!
Sexual dysfunction (SD) is characterized by those psychological and
physiological changes that negatively impact sexuality.
SD is not part of the normal aging process!!
It is a result of physical illness and environmental
and/or psychological factors.
Sexual desire disorder (decreased libido)
Sexual arousal disorder
Orgasm disorder
Sexual pain disorder
DSM IV Diagnostic & Statistical Manual
of Mental Disorders
22
Shabsigh and Rowland, J Sex Med, 4(5) 2007; Clayton and Ramamurthy, Adv Psychosom Med, 29 2007
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Sexuality & Sexual Dysfunction:
Unmet Need for Cancer Survivors
· SD affects 43% of women and 31% of men in the
United States.
· SD is one of the more common enduring consequences
of cancer treatment and one that is not often addressed.
· 73% of women with hematological malignancies
reported decreased libido, and 48% were dissatisfied
with their sex life.
· Publications regarding SD in cancer patients are limited.
· Co-morbidities impact sexual function.
23
Ganz & Greendale, J Natl Cancer Inst 2007; Tierny et al, Europ J Onc Nursing 2007
The Impact of Myeloma
Treatment on Sexuality
Our knowledge of the effects of novel
myeloma treatment on sexuality is very
limited:
Patients are reluctant to discuss the
issue
Sexuality assessments are not
performed
24
Murphy and O'Donnell, Haematologica, 92 (10), 2007
12
Sexual Dysfunction:
Communication Is Critical!
If no one asks, Tell Them You Need to Talk
· Urgent need for open communication between
physicians, nurses, and their patients
Multiple well-established treatments for SD are
available for male and female patients.
· Patients may be unable or unwilling to verbalize
this as a side effect.
This is often placed on the back burner, as treatment is most
important.
25
IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation
Health Maintenance
Immortal Words of Rosanne Rosannadanna
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13
Pay Attention:
· Expectations for MM patients:
>90% response upfront
CR + VGPR 60%
3-year survival 80 to 90%
6-year survival 60 to 70%
>10-year survival 30 to 40%
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3 "Seasons of Survival"
· Acute survival: Diagnosis
treatment
Fear and anxiety
Confrontation of mortality
Family needs
· Extended survival: watchful waiting, consolidation, or
intermittent therapy
Fear of recurrence
Physical limitations
adaptation to work and home
Experiences variable
· Permanent survival: "cure"
Insurance and employment problems
Long-term effects of therapy
28
Mullan, NEJM 1985
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Optimizing Survival: Importance
of Health Maintenance
· Myeloma patients are
expected to live longer
· Good state of health provides
the opportunity to improve
survival by maintaining patients
on appropriate therapy
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Impact of Novel Therapies
on Survivorship Care
· Unexpected new long-term
complications
· Second cancers
· Long-term maintenance for survivors:
quality of life
· Family/social problems
· Financial/insurance
concerns
30
IMF NLB Long-Term Care Survivorship Plan, manuscript in preparation
15
Survival is Worth It!
· MM patients are facing multiple risks:
Illnesses usually experienced by general
population of the same age
Morbidities of MM itself
Complications associated with MM treatments
· MM-ers still have to look at:
- Cardiovascular disease
- Secondary malignancies
- Endocrine disorders
- Bone metabolism disorders
- Sensory changes
- Depression
- Nutrition
- Chemical dependency
31
Longo & Anderson, K. (2005). Plasma cell disorders. In Harrison's principle of internal medicine (16th ed., pp. 656-662).
New York: McGraw-Hil
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