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 4/5/22 webinar on Relapsed Refractory Multiple Myeloma
How readily available are the chimeric antigen receptor (CAR) T-cell therapies?
Access to CAR T-cell therapy by patients who need it is currently a challenge despite the approval of two different CAR T-cell therapies (Abecma and Carvykti). A patient is unable to decide today that he or she wants CAR T-cell therapy and expect to receive the therapy tomorrow. Most large cancer centers (for example, Memorial Sloan Kettering Cancer Center or Dana-Farber Cancer Institute) are able to administer CAR T-cell therapy to 2 to 4 patients per month. The reason so few patients can be treated per month is because the process of generating CAR T involves many steps. First, a patient’s T cells have to be collected—this is done by a procedure called apheresis; second, the patient has to wait 4 to 6 weeks after T cell collection for the manufacturing of the CAR T cells. During the waiting time, some patients may need bridging therapy (that is, a cycle of combination therapy) if their M-protein values start to rise. Ultimately, a cancer center may have a waiting list for patients who are eligible to receive CAR T-cell therapy. Having 2 CAR T-cell therapies available now might lessen the waiting time and the future availability of new drugs like bispecific antibodies that don’t require manufacturing time, will be another option patients can consider.
How you can tell if a patient has high-risk disease and how does having high-risk myeloma affect which therapies they may receive at relapse?
Myeloma patients who do not enjoy long-term clinical remission are considered to have high-risk disease. To be high risk means that patients have genetic or clinical features that make their myeloma more aggressive, meaning they may relapse quickly after treatment or spend a shorter time in remission than patients who do not have those genetic or clinical features. Certain blood and bone marrow test results can help physicians identify patients with high-risk myeloma. The tests include measuring the levels of beta-2 microglobulin (β2m), albumin, and lactate dehydrogenase (LDH) in the blood and the identification of cytogenetic abnormalities in the bone marrow by a test called fluorescence in situ hybridization, or FISH. Patients with high-risk disease have high levels of β2m, albumin, and LDH and they have cytogenetic abnormalities such as deletion of the short arm of chromosome 17 (del17p) and/or translocations of chromosomes 4 and 14 or 14 and 16. Other chromosomal abnormalities associated with a high risk of poor outcomes is the gain of chromosome 1 (an additional copy or copies of this chromosome). There is no treatment or regimen that is specific for relapsed/refractory patients with high-risk myeloma. Current therapies, such as those that incorporate the use of an anti-CD38 monoclonal antibody such as Darzalex or Sarclisa, can be used in patients with high-risk disease, but high-risk patients are still more likely to relapse sooner than patients who don’t have high-risk disease.
What should I do if I obtain second (or third) opinions for my next treatment plan after my third relapse, and they are all different?
Luckily, there are a variety of treatment options for patients with relapsed/refractory myeloma. Because of the many options, there is no one, clear standard and that may be the reason you may receive differing opinions. The best advice is to do your own research and find out as much as you can about the options discussed with you and then determine which might be the option you are most comfortable with. Comfort can mean different things to different people, but things like certain side effects that you want to avoid, how the treatments will be administered (that is, do you prefer intravenous, subcutaneous, or oral), or your interest in participating in a clinical trial can all be factors to consider when deciding on the best option. Be sure to share the opinions you obtained with your primary oncologist and make him or her your partner in helping you decide on the best treatment plan for you.
If you missed our webinar, you can see it here. If you have additional questions, check out our Facebook Live event on 4/14 at 1PM ET, where 2 myeloma experts and a patient will be answering your questions on this topic.
