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.
Answers to 3 FAQs from our 6/29/22 Expert Session on Myeloma Highlights from the 2022 ASCO Meeting
Answers to 3 FAQs from our 6/29/22 Expert Session on Myeloma Highlights from the 2022 ASCO Meeting
How did high-risk myeloma patients fare on the DETERMINATION TRIAL (early vs late autologous stem cell transplantation)?
Patients considered to have high-risk myeloma based on their cytogenetics such as those with the translocation of chromosomes 4 and 14 benefited from early transplant in terms of longer time until disease progression, but patients with a deletion of chromosome 17p did not. Other subgroups (such as those with the translocation of chromosomes 14 and 16) had too few patients to determine their outcome or draw conclusions. Patients with chromosome 1 abnormalities were not a prespecified high risk subgroup at the time of the study design; however, study investigators plan to review the data from those patients in a future analysis. Patients with revised International Staging System (R-ISS) stage I and R-ISS stage II also benefited from early transplant, but patients with R-ISS stage III did not. However, as with the overall population of patients in the study, patients with high-risk disease did not live longer (that is, overall survival was not affected by early transplant). It is suggested that more time is needed to observe the high-risk patient groups to confirm whether early transplant has an impact on overall survival.
What options do patients have once chimeric antigen receptor (CAR) T-cell therapy stops working?
Based on data from the clinical trials of the two, FDA-approved, BCMA-directed CAR T-cell therapies (Abecma and Carvykti), almost all patients respond to treatment and the response lasts for about one year. For those patients who achieve a complete response or who achieve minimal residual disease (MRD) negativity in the first month, response may be longer than one year. Unfortunately, all patients will eventually relapse and it is still unclear as to why. It is possible that CAR T-cells do not persist long in the blood or that the expression of BCMA may decrease (or both). Based on retrospective studies, it has been observed that other BCMA-directed therapies (such as bispecific antibodies) can be used after BCMA-directed CAR T-cell therapy relapse. Very few patients respond to the same CAR T-cell therapy.
What is the latest information on COVID-19?
Myeloma patients still need to be vigilant about the potential for COVID-19 infection. The latest information and recommendations for myeloma patients include:
- The FDA has approved a third booster for the COVID vaccine (or a fifth dose) which is only for immunocompromised individuals (such as myeloma patients) and individuals over 50. There is no contraindication for receiving the booster after receiving Evusheld. The fifth dose should be delivered at least four months after the fourth dose.
- Paxlovid and Evusheld are two medications recommended for most myeloma patients. Paxlovid is an antiviral that significantly reduces viral load and its use is important in the early part of COVID infection. Paxlovid can have some drug-drug interactions (particularly with high cholesterol medication) and may cause some gastrointestinal side effects (for example, nausea). Evusheld is a monoclonal antibody recommended for use as post-exposure prophylaxis or prevention.
- It is important to note that there is still a benefit for myeloma patients who do not respond (that is, are unable to make antibodies to the vaccine) to receive the COVID vaccine and boosters since the vaccine may stimulate T-cell and B-cell responses that cannot be measured with current blood tests.
- If you still have questions about COVID vaccination or medications available to you, please contact your health care team.
- Please read our recent blog post here on COVID-19 therapies.
To learn more about all the myeloma studies presented and highlighted from the 2022 American Society of Clinical Oncology meeting, please view our blog post here.
