Rob Miani joined the MMRF team as Chief Financial Officer in 2016. Most recently he was the Vice President of Finance and Corporate Controller of Aptuit, LLC, a global contract research organization providing integrated early discovery to mid-phase drug development services in the pharmaceutical industry. Rob has over 20 years of leadership experience in the private and public sectors, holding managerial positions in the renewable energy, private equity, Internet and technology industries, including Davenport Newberry, Oak Investment Partners and INT Media Group. He began his career with Arthur Anderson LLP in the Assurance and Business Advisory Services Division. Rob is a CPA and received his BS degree in Accounting from Fairfield University.
Multiple Myeloma & COVID-19 Guidelines for Health Care Providers
COVID-19 Guidelines for Health Care Providers Who Treat Patients Diagnosed with Multiple Myeloma
General practice guidelines
- Make sure patients understand their increased risk of infection with COVID-19 due to their weakened immune systems and their need to take extra precautions
- Decisions should be based on the risks (coronavirus exposure, delayed or altered treatment) versus the benefits (lower risk of exposure)
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Myeloma patients should avoid coming into clinic if at all possible, to minimize risk of coronavirus exposure in health care facilities. This means…
- Confer with patients via telemedicine rather than face to face
- Consider delaying treatments that involve infusion or injection
- Consider switching to oral myeloma medications if appropriate, ie. immunomodulatory drugs, oral proteasome inhibitor, alkylators, HDAC inhibitors, SINE
- If IV drugs are necessary, consider using at decreased frequency or faster infusion time
- Decrease frequency and dose of dexamethasone
- Utilize alternate locations for assessment, including local labs or imaging centers
If the patient must come into the clinic, they should wear a mask, wash their hands frequently, avoid touching their face, and maintain social distancing. Prior to their appointment, patients should wait in their car, avoiding the waiting room, and they should be called in for their appointment via their cellphone.
Therapy Options for Myeloma Patients
Decisions should be made on a case by case basis, taking into account disease stage, risk, age, and comorbidities. The American Society of Transplantation and Cellular Therapy (ASTCT) has issued recommendations regarding management of auto-transplant.
For transplant-eligible, newly diagnosed patients:
- Elective stem cell mobilization and autologous stem cell transplantation (ASCT) should be delayed until after crisis
- Induction chemotherapy may be continued or substituted with a dose-reduced or oral regimen as appropriate
For non-transplant-eligible newly diagnosed patients:
- Prescribe oral treatments if possible, eg. Lenalidomide/dexamethasone (dosed appropriately for age)
- Monitor tolerability/response via telemedicine visits, lab testing as feasible
- In cases of Very Good Partial Response or better to lenalidomide/dexamethasone, consider discontinuation of dexamethasone and single agent lenalidomide maintenance as appropriate
For relapsed/refractory myeloma:
- Similar recommendations to those given in the upfront setting
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If good response to triplet IV regimen, minimize clinic/hospital visits by…
- Using weekly instead of biweekly regimens (eg carfilzomib/bortezomib)
- Taking 20 mg/kg of Elotuzumab every four weeks instead of 10 mg/kg every two weeks
- Use oral agents (eg. ixazomib) if possible
- Switch to monthly daratumumab as soon as possible, rapid infusion for C2+
- If ASCT is being considered for patients with progressive disease, recommend discussing risks, benefits and alternatives with patient
Transplant and cellular (CAR T-cell) therapy
- ASCT for consolidation should be postponed if at all possible, see above
- ASCT for salvage/progressive disease – decisions should be made on case by case basis; if patient has active/high risk disease, treatment should not be postponed
- For ASCT or cellular therapy candidates with symptoms of respiratory infection, patients should be tested for virus by multiplex PCR if available; if testing is not available, all procedures should be deferred a minimum of 14 days and symptoms have resolved. Even if virus testing is negative, deferral should be considered, weighing risks of underlying disease progression
- If SARS-CoV-2 is detected in a candidate, procedures should be deferred. For high risk patients, procedures should be deferred until patient is asymptomatic and has had 2 negative PCR tests approximately 1 week apart (deferral of 14 days minimum)
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All transplant and cellular therapy procedures should be deferred at least 14 and preferably 21 days from the last day of travel or contact for ASCT and cellular therapy candidates who…
- Have been in close contact with a person infected with SARS-CoV-2
- Have been in close contact with a person who has traveled to a region where SARS-CoV-2 is prevalent in the community
- Have traveled to a region where SARS-CoV-2 is prevalent in the community
- If testing is available, all candidates should be screened for SARS-CoV-2 infection regardless of the presence of symptoms
- For cellular therapies, new enrollment should be delayed if possible (use of oral selinexor or other bridging therapies strategy)
Clinical trials
- Patients already participating in clinical trials should be continued if it is safe to do so
- New enrollment in clinical trials should carefully weigh benefits vs risks
- Recommendations in each country should be carefully followed
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FDA guidance:
- For ongoing trials, ensuring patient safety is the most important consideration, and sponsors should modify study conduct accordingly. Decisions include whether to continue trial recruitment, continue use of investigational agent for those participating in the trial, and possible changes in patient monitoring; patients should be kept informed of any changes to the study that impact them
- Continuation or discontinuation of study participants depends on specific circumstances including the nature and supply chain of the investigational agent, ability to safely monitor patients, and the nature of the disease under study
- As trial participants may not be able to travel to the study site for protocol specified visits, sponsors should consider alternative means of assessment (by phone, virtual visit, alternative locations such as local labs or imaging centers) if patient safety can be assured. If participants no longer have access to the investigational agent, additional monitoring may be necessary as the agent is withdrawn
- Mandated COVID-19 screening of participants at a clinical site does not need to be reported as an amendment to the protocol unless the sponsor is collecting that data as part of a new research objective
- Changes to protocols to ensure safety of trial participants may be implemented without prior IRB approval but must be reported afterward.
- If changes in study visit schedules or other changes result in missing information, the specific explanation for the missing data must be reported
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Special considerations if visits at clinical sites will be significantly impacted:
- For distribution of typically self-administered investigational agents, alternative secure delivery methods may be available
- For agents normally administered in a health care setting, alternative administration (home nursing or administration by trained non-study personnel) is recommended,
- investigational agent product accountability must be maintained and documented
Resources
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- Interim Guidelines for COVID-19 Management in Hematopoietic Cell Transplant and Cellular Therapy Patients
- International Myeloma Society Recommendations for the Management of Myeloma Patients During the COVID-19 Pandemic
- National Institute of Allergy and Infectious Diseases COVID-19 Treatment Guidelines
- For further questions on clinical trial conduct during the COVID 19 pandemic, please email [email protected]
