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Considerations of COVID-19–Specific Myeloma Guidelines in New York City

 

April 29, 2020

Considerations of COVID-19–Specific Myeloma Guidelines in New York City

 

By Donna Catamero, ANP-BC, OCN®, CCRC, Erika Florendo, ANP-BC, Nadege Stevens, BSN, and Daniel Verina, DNP, RN, ACNP-BC, Mount Sinai Hospital, New York, New York

 

Multiple myeloma (MM) is the second most common hematological cancer and remains incurable. With a median age at diagnosis of 69 years old, MM patients also have decreased immunity (functional or absolute hypogammaglobulinemia) and other comorbidities (such as cardiac and/or pulmonary diseases) that put them at a higher risk for infection.

Infection is the most common cause of morbidity and mortality in MM. Cancer patients have an increased risk of SARS-CoV-02 infection and have poorer outcomes than individuals without a cancer diagnosis (NCCN, 2020a). A study done by Liang and colleagues (2020) evaluating novel coronavirus (COVID-19) infections showed that cancer patients had a higher risk of a severe event (requiring admission to an intensive care unit) in 39% of patients with cancer vs. 8% of patients without cancer. The risk of COVID-19 infection during transit, nosocomial acquisition, or transmission when a patient goes to and from a health-care provider (HCP) can create barriers to treatment.

COVID-19 in New York
The first case of COVID-19 in New York was confirmed on March 1, 2020. As of April 30, 2020, there have been 304,372 confirmed cases in the state, and of those, 18,321 people have died (New York State Department of Health, 2020). New York has a higher confirmed coronavirus case volume than any country in the world, besides the United States, and New York City has become the epicenter, with more than half of the state’s confirmed cases.

So how, as oncology HCPs, do we provide effective treatment and monitoring to MM patients in a time when social distancing is a priority to minimize the further spread of COVID-19? Here, we discuss how advanced practitioners (APs) and staff in the MM program at Mount Sinai Hospital in New York City modified patient care guidelines during the COVID-19 pandemic in an effort to balance the need for social distancing and optimizing patient care.

Clinical Practice
The appropriate management of patients with MM requires consideration of numerous patient- and disease-related factors, such as type of therapy and remission status. Continuous or maintenance therapy has been shown to improve progression-free survival in several studies (Dimopolous et al., 2020; McCarthy et al., 2017).

To attain and maintain remission in MM, available therapies involve a combination of chemotherapy and novel therapies (oral, subcutaneous, and/or intravenous). Each drug has different and complementary mechanisms of action and modalities, such as proteasome inhibitors (PI), immunomodulators (IMiD), histone deacetylase (HDAC) inhibitors, monoclonal antibodies, and exportin-1 (XPO1) inhibitors (NCCN, 2020b). Assessment of a patient’s remission status requires laboratory monitoring for therapy tolerance (complete metabolic panel [CMP], complete blood count [CBC], uric acid) and disease-specific serum and urine monoclonal studies.

Table 1. International Myeloma Working Group (IMWG) Criteria for Treatment Response

Response

International Myeloma Working Group (IMWG) Criteria

sCR

  • CR as defined below, plus normal FLC ratio and absence of clonal cells in bone marrowby immunohistochemistry or immunofluorescence

CR

  • Negative immunofixation on the serum and urine samples
  • Disappearance of any soft tissue plasmacytomas
  • < 5% plasma cells in bone marrow

VGPR

  • Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h

PR

  • ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by > 90% or to < 200 mg/24 h
  • If the serum and urine M-protein are unmeasurable, a > 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria
  • If serum and urine M-protein are not measurable, and serum free light assay is also not measureable, > 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was > 30%
  • In addition to the above listed criteria, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required

SD

  • Not meeting criteria for CR, VGPR, PR, or progressive disease

PD

  • Requires one or more of the following:
    • Increase of > 25% from lowest response value in any one or more of the following:
      • Serum M-component and/or (the absolute increase must be > 0.5 g/dL)
      • Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
      • Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL.
  • Bone marrow plasma cell percentage; the absolute percentage must be > 10%.
  • Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
  • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder

Note. sCR = stringent complete response; FLC = free light chain; VGPR = very good partial response; PR = partial response; SD = stable disease; PD = progressive disease.

 

Cognizant of these key factors during the pandemic, oncology APs, nurses, physicians, and staff at Mount Sinai convened to determine how patients should be best managed. Important considerations in addition to remission status and type of therapy (IV/SC or oral) included the patient’s performance status and chemotherapy oral adherence. Based on these, the group determined:

  1. Newly diagnosed patients or relapsed patients with significant cytopenias who need parenteral therapy should continue with the current therapy, but the number of visits should be decreased to limit exposure to other HCPs. If the patient has had a good response to treatment, consider changing to an oral regimen.

  2. Patients in remission (CR, VGPR) should consider switching therapy to an oral regimen (IMiDs, PIs, dexamethasone, and/or HDAC inhibitors)

  3. Stem cell harvest (SCH) and stem cell transplant (SCT) should be delayed if the patient continues to respond to the current therapy.

Oral chemotherapies have changed the landscape of cancer therapy and are attractive options during the pandemic due to the flexibility and convenience for the patient with minimal disruption in their activities of daily living (ADLs; Schneider, Hess, & Gosselin, 2011). However, barriers to adherence exist, such as health literacy and complex oral schedules. When starting patients on a new oral regimen, a family member or significant other should be present during the initial visit (whether it is an in-person or telemedicine appointment) to ensure adequate understanding. The patient must be able to read back the proposed new oral chemotherapy to avoid dosing errors. Health-care providers should create a schedule in the form of a calendar or diary for patients to fill out.

At our institution, when starting a new oral therapy, the patient is required to call back once the oral drug has arrived to confirm dosing and schedule to review understanding. Increased frequency of video or telephone visits may be necessary to enhance adherence, monitor for side effects, and provide reinforcement on the new treatment schedule.

Depending on the regimen, the patient may be instructed to take oral corticosteroids and an oral antiemetic as premedication before taking the oral chemotherapy at home, or on an as-needed basis. Patients are instructed to take antiemetics and over the counter antidiarrheals only if symptoms are clearly related to chemotherapy as needed. Lastly, advising patients not to put chemotherapy pills in a pill box and instead keeping them in the original bottle will limit confusion.

Clinical Research Implications
The current COVID-19 pandemic has had a devastating impact on clinical trials given the additional stress on medical institutions, as well as the need to keep patients and staff safe. Due to increased community transmission and being in the epicenter of the US COVID-19 crisis, we established a policy for our MM clinical trial patients. In addition, the FDA issued guidance concerning challenges facing clinical trial accrual and continued treatment with investigational drugs (FDA, 2020). 

As the number of patients with suspected or confirmed cases of COVID-19 increased, we approached each clinical trial patient on a case-by-case basis. An important strategy was to support and enable physical distancing by limiting in-person contact and replacing it with alternative forms, while maintaining the per protocol procedures.

We determined which on-site study visits were essential (e.g., continued treatment visits for patients who were rapidly progressing or newly diagnosed, critical safety lab checks, and testing required for treatment decisions). Patients who came for on-site visits were encouraged to use private transportation, and both social work and study sponsors assisted with arranging transportation.

Visits that were not considered urgent or were thought to be elective (e.g., on day 1 visits for adverse event monitoring or research sample collection, bone marrow biopsies, scans and supportive care visits) were either skipped or transitioned into a telehealth visit with a provider via video or telephone.

We used temperature-monitored shipping procedures for our oral investigational drugs to be mailed to the patient’s home so that patients did not have to come into the cancer center. Nurses and study staff mailed patients their study medication diaries, home pregnancy tests, and did quality-of-life questionnaires over the phone. In order to obtain vital signs, we asked patients to take their own weight and blood pressure at home. For patients who lived far from the institution, a local lab that was closer to their home to monitor their bloodwork or a mailer kit was used, which allowed patients to have tubes drawn and then shipped to the Mount Sinai lab.

Given the increased risk of COVID-19 complications in oncology patients, enrollment on all of our clinical trials were halted. The institution reached out to study sponsors and obtained approval for the plan to reduce the risk to our immunocompromised MM patients on trial.

In an effort to minimize patient travel and community exposure to COVID-19, we asked to skip certain treatment days in patients who were in long-term remission with little to no detectable disease and transitioned some patients to oral therapies only.

Planned protocol deviations and subject updates were compiled per trial and a report was sent to the sponsor each week, and then subsequently to the IRB for documentation. Lastly, all on-site monitoring visits were cancelled to minimize exposure, and remote monitoring was implemented. 

Patient Triage
During this pandemic, nursing triaged the calls into the practice by answering questions regarding COVID-19 and its impact on treatment. By using a multidisciplinary approach, we were able to continue treating our patients and reduced their risk of exposure to SARS-CoV-02 (Table 2).

Table 2. Frequently Asked Questions by Patients With Multiple Myeloma

Question

Response

I have an appointment with my doctor on this date. Do I have to come in?

Telemedicine has been implemented. Patients are informed that their actual visit with the doctors will be via telemedicine (video visit or a phone call). Instructions are sent to patients on how to set up visits. For those patients who do not have access to smart devices, they are given a phone call from their provider to discuss their treatment and disease.

If you stop my treatment, will my disease get worse?

Risks and benefits are explained to patients regarding chemotherapy and treatment interruptions during the COVID-19 pandemic.

Do I have to come in to do labs?

If previous labs were stable, patients were told to delay or skip a scheduled blood draw. Other options for obtaining bloodwork are discussed with patients, such as going to a local lab where patients wait in their cars and are brought in just for the blood draw or scheduling an in-home blood draw by a mobile lab service.

My family member has coronavirus. What should I do?

We encouraged them to isolate themselves from sick family members, as well as follow protocol of hand hygiene,cleaning areas with appropriate sanitizers, and notifying HCPs about symptoms. Due to the unpredictability of this infection, we have encouraged patients to get tested for COVID-19 before starting on chemotherapy.

I have a fever, cough, and shortness of breath. Do I have COVID-19?

Patients who called with active symptoms were screened via phone with key questions.

  1. Do you have a fever? (temperature of > 100.4°F or 38°C)
  2. Do you have a cough?
  3. Do you have shortness of breath?
  4. Do you have nausea, vomiting, or diarrhea
  5. Have you been in contact with a known case of COVID-19?

If it is determined that the patient is high risk for COVID-19 infection, an email is sent to our referral team, which consists of coordinators and nurse leaders, and patients are scheduled to come in for testing.

Can I get extra medications sent to me?

For all non-female patients or females of non-childbearing potential, we requested a 56-day supply of their immunomodulatory drugs. For women of childbearing potential, they are instructed to take a home pregnancy test, which is mailed to the patient’s home. Once the result of the home test is available, the patient calls us and a pregnancy test is documented in the chart.

For those patients on oral dexamethasone at home, we instructed patients to check their temperature on the morning of taking the dexamethasone to ensure fevers are not being masked. We reminded patients to call if they experience fever, upper respiratory symptoms, or known COVID-19 exposure.If a patient is asymptomatic but with known COVID-19 exposure, we held oral chemo (especially steroids) for at least 7 days to ensure a clear clinical picture.

 

Although COVID-19 has presented many challenges in the treatment of MM, the collaborative efforts by oncology advanced practitioners, registered nurses, physicians, other members of the care team, and patients through shared decision-making can improve care and adherence to treatment, as well as optimize care during this difficult time.

 

References

Dimopoulos, M. A., Jakubowiak, A. J., McCarthy, P. L., Orlowski, R. Z., Attal, M., Bladé, J.,…Anderson, K. C. (2020). Developments in continuous therapy and maintenance treatment approaches for patients with newly diagnosed multiple myeloma.  Blood Cancer Journal, 10, article number 17. https://doi.org/10.1038/s41408-020-0273-x

Liang, W., Guan, W., Chen, R., Wang, W., Li, J., Xu, K.,…He, J. (2020). Cancer patients in SARS-CoV-2 infections: A nationwide analysis in China. The Lancet Oncology, 21(3), 335–337. https://doi.org/10.1016/S1470-2045(20)30096-6

McCarthy, P. L., Holstein, S. A., Petrucci, M. T., Richardson, P. G., Hulin, C., Tosi, P.,…Attal, M. (2017). Lenalidomide maintenance after autologous stem-cell transplantation in newly diagnosed multiple myeloma: A meta-analysis. Journal of Clinical Oncology, 35(29), 3279–3289. https://doi.org/10.1200/JCO.2017.72.6679

National Comprehensive Cancer Network. (2020a). Coronavirus Disease 2019 (COVID-19) Resources for the Cancer Care Community. Retrieved from https://www.nccn.org/covid-19/default.aspx

National Comprehensive Cancer Network. (2020b). NCCN Clinical Practice Guidelines in Oncology: Multiple myeloma. Version 3.2020. Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf

New York State Department of Health. (2020). Persons testing positive by county. Retrieved from https://covid19tracker.health.ny.gov/views/NYS-COVID19-Tracker/NYSDOHCOVID-19Tracker-Map?%3Aembed=yes&%3Atoolbar=no&%3Atabs=n

Schneider, S. M., Hess, K., & Gosselin, T. (2011). Interventions to promote adherence with oral agents. Seminars in Oncology Nursing, 27(2), 133–141. https://doi.org/10.1016/j.soncn.2011.02.005

U.S. Food & Drug Administration. (2020). FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency. Retrieved from https://www.fda.gov/media/136238/download


 

Read more from the APSHO Advance: Special COVID-19 Series

 



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