Hi, this is Sandy Kurtin, nurse practitioner at the University of Arizona Cancer Center. We are going to talk about pomalidomide or Pomalyst. Pomalidomide, or Pomalyst, is an immunomodulatory compound with pleiotropic property shown to be beneficial in treating multiple myeloma. Dr. Richardson and his colleagues studied pomalidomide, otherwise known as pom, in combination with dexamethasone compared to pomalidomide alone in a relapsed/refractory multiple myeloma population. The trial did allow a crossover for patients with progressive disease on the pomalidomide alone arm of the trial; 61 of these patients, or 56%, went on to receive pom and low-dose dex due to progressive disease. Response rates favored the pom–dex arm of the trial with PR of 34% versus 13% and with responses seen in patients refractory to novel agents. Lenalidomide-refractory patients responding were 30%, and bortezomib-refractory patients responding were 16%, suggesting a synergistic effect of the combined regimen. Myelosuppression in particular grade greater than 3 neutropenia was the most common reason for treatment discontinuation. This trial confirmed the superior efficacy of pom in combination with low-dose dex versus pom alone. On February 8, 2013, the US Food and Drug Administration granted accelerated approval to pomalidomide, or Pomalyst, for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. As a condition of this accelerated approval, the FDA will require submission of the results for clinical trial CC4047MM007, a randomized trial of pomalidomide added to bortezomib and low-dose dexamethasone compared to bortezomib plus low-dose dexamethasone in patients with previously treated multiple myeloma. Pomalidomide is now being evaluated in a number of trials to establish optimal dosing and tolerance in combination with other novel agents. Pomalidomide is administered orally 4 mg once-daily on days 1 through 21 of a 28-day cycle. It should be taken without food, so at least 2 hours before a meal and at least 2 hours after a meal. It is supplied in 1, 2, 3, and 4 mg capsules to allow for variable dosing. They should not be broken, chewed or opened. Taking the pomalidomide at the same time each day is recommended. If a dose is missed, it is recommended the pomalidomide be taken immediately if it has been less than 12 hours or skipped and taken at the regularly scheduled time if it has been more than 12 hours. Thromboprophylaxis is recommended using 81 mg of aspirin for low-risk patients and full anticoagulation using enoxaparin (Lovenox) or warfarin (Coumadin) for patients at higher risk. Like the other immunomodulatory agents, pomalidomide requires administration using a REMS program for safety. Precautions for patients of childbearing age are required. The most common treatment emergent adverse events reported in the clinical trials included myelosuppression, fatigue, and pneumonia. Dose modification and supportive therapies are recommended for management of more severe adverse events. You can find out more about pomalidomide, or Pomalyst, at the Managing Myeloma website.
Jagannath S, Hofmeister CC, Siegel DS, et al. Pomalidomide (POM) with Low-Dose Dexamethasone (LoDex) in Patients (Pts) with Relapsed and Refractory Multiple Myeloma Who Have Received Prior Therapy with Lenalidomide (LEN) and Bortezomib (BORT): Updated Phase 2 Results and Age Subgroup Analysis. Blood [ASH Annual Meeting Abstracts]. 2012;120(21):Abstract 450.
Richardson PG, Siegel D, Baz R, et al. Phase 1 study of pomalidomide MTD, safety, and efficacy in patients with refractory multiple myeloma who have received lenalidomide and bortezomib. Blood. 2013;121(11):1961-1967.
Vij R, Hofmeister CC, Richardson PG, et al. Pomalidomide (POM) with Low-Dose Dexamethasone (LoDEX) in Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Outcomes Based on Prior Treatment Exposure. Blood [ASH Annual Meeting Abstracts]. 2012;120(21): Abstract 4070.
Kumar SK, Lee JH, Lahuerta JJ, et al.; International Myeloma Working Group. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26(1):149-157.
U.S. Food and Drug Administration. Drugs. Drug Approvals and Data Bases. Approved Drugs. Pomalidomide. February 8, 2013. Accessed at: www.accessdata.fda.gov/scripts/cder/daf/ on June 27, 2013.
Pomalyst (pomalidomide), capsules for oral use. Highlights of Prescribing Information. Form POMPI.001/MG.001 02/13. Accessed at www.pomalyst.com/docs/prescribing_information.pdf on June 27, 2013.
ClinicalTrials.gov Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (OPTIMISMM). ClinicalTrials.gov Identifier: NCT01734928.
Reviewed on January 17, 2017 for clinical relevance.