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.
4/10/21 Patient Summit – Top FAQs
How can peripheral neuropathy be managed?
For many patients, the development of peripheral neuropathy is a challenge to deal with. What many patients may not know is that peripheral neuropathy—that is, nerve injury in the fingertips and toes—is part of the myeloma disease process. The effects of M protein and inflammatory proteins produced by myeloma cells on nerves and small vessels can cause neurotoxic damage. Peripheral neuropathy is then made worse by certain myeloma treatments which is why the presence of existing neuropathy is a consideration in the selection of which myeloma therapy is given to patients. For more details on the management of peripheral neuropathy, view the FAQ from our recent supportive care webinar here.
What is the status of Venclexta (venetoclax) for use in patients with MM who harbor the chromosomal translocation t(11;14)?
Venclexta, a drug that targets a protein called Bcl-2 found in cancer cells, is approved for use in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) but not yet approved for patients with myeloma. Initial studies of Venclexta combined with dexamethasone in myeloma patients showed encouraging activity in those who harbored the chromosomal translocation 11;14—t(11;14). About 15% of myeloma patients have this translocation (detected by FISH testing from a bone marrow biopsy). And when Velcade was added to this combination and studied in all myeloma patients (not just those with t[11;14]) in phase 1 trials it was shown to have a tolerable safety profile. However, a large, phase 3 trial (called the BELLINI trial) of Venclexta in combination with Velcade and dexamethasone for patients with relapsed/refractory myeloma resulted in more patient deaths than the control arm of that trial (Velcade-dexamethasone) and as a result, further investigation of Venclexta in myeloma patients was put on hold—a hold that has been lifted as of June 2019. And shortly thereafter, the BELLINI trial investigators reported on the use of biomarkers (such as expression of t[11;14] and expression of the Venclexta target, Bcl-2) to select myeloma patients who would specifically benefit from treatment with Venclexta-Velcade-dexamethasone. The investigators showed that patients with relapsed/refractory myeloma harboring either t(11;14) or myeloma cells expressing high levels of Bcl-2 benefited the most from Venclexta -Velcade-dexamethasone and that the benefits outweighed the risks of treatment with Venclexta.
Ultimately, many in the myeloma community believe that Venclexta has a role in myeloma treatment specifically as the first targeted approach—or precision medicine option—for patients with t(11;14) or Bcl-2 overexpression. Several clinical trials of Venclexta in patients with myeloma are ongoing and its approval for myeloma patients is eagerly awaited.
How are the gastrointestinal effects (that is, constipation and diarrhea) of Revlimid (lenalidomide) managed?
The use of Revlimid is commonly associated with gastrointestinal problems, such as constipation and diarrhea. Typically, patients initially starting out on Revlimid therapy may not experience these issues. However, its use over a long period of time (for example, while taking Revlimid as maintenance therapy), constipation, diarrhea, gassiness, and discomfort become common complaints by patients. Medications to help manage symptoms (such as Imodium to help with diarrhea) or to target underlying causes (such as colestipol to bind up bile acids), as well as changes in diet, may be helpful in addressing or preventing some of these effects.
Also, it is important to rule out any other specific gastrointestinal problems with a gastroenterologist.
