The in-class transition to oral ixazomib-lenalidomide-dexamethasone appears feasible in randomized clinical trial ineligible patients with multiple myeloma (MM) in US community oncology centers despite the range of comorbidities, according to data presented at the virtual 2020 Association of VA Hematology/Oncology (AVAHO) Annual Meeting.
“In MM, registry analyses indicate that up to 40% of real-world population patients are not eligible for phase 3 trials based on standard criteria,” said Suman Kambhampti, MD, Kansas City Veterans Affairs Medical Center, Missouri, during his presentation.
“Notably, veterans are frequently underrepresented in clinical trials,” he continued.
The US MM-6 trial is an ongoing community-based trial evaluating in-class transition from parenteral bortezomib-based induction to an all-oral ixazomib-lenalidomide-dexamethasone regimen in patients with MM.
The enrollment criteria for the MM-6 trial allowed for a broader patient population compared with standard clinical trials. This allowed for a patient population more representative to the real-world setting.
The trial is enrolling patients with newly diagnosed MM, not eligible for transplantation, at 22 community oncology centers in the US, including 3 Veterans Affairs hospitals. Patients with stable disease or better after 3 cycles of bortezomib-based induction will receive ixazomib-lenalidomide-dexamethasone for up to 39 28-day cycles or until disease progression or toxicity.
A total of 84 patients consecutively enrolled using standard randomized clinical trial eligibility criteria were reviewed. The initial 6 criteria used to determine the proportion of patients eligible were renal dysfunction, congestive heart failure, stroke, prior malignancies, chronic obstructive pulmonary disease, and memory loss.
Based on the 6 criteria, a total of 24 (29%) patients may have been ineligible for randomized clinical trials: 12% (n = 10) had renal dysfunction, 7% (n = 6) CHF, 6% (n = 5) stroke, 5% (n = 4) had prior malignancies; 5% (n = 4) had COPD, and 2% (n = 2) had memory loss. Additionally, 6% (n = 5) had >1 criterion.
Among the 24 patients deemed ineligible for randomized clinical trials, 75% (n = 18) 42% (n = 10), and 54% (n = 13) received the highest starting doses of ixazomib (4 mg), lenalidomide (25 mg), and dexamethasone (40 mg), respectively.
Dose reductions were reported for ixazomib, lenalidomide, and dexamethasone in 29% (n = 7), 25% (n = 6), and 21% (n = 5) of patients, respectively. Treatment discontinuation occurred in 50% (n = 12) of patients.
“Our analyses indicate that in-class transition to ixazomib-lenalidomide-dexamethasone appears to be feasible in these patients despite the range of comorbidities," Dr Kambhampti said.
“Furthermore, this treatment approach results in prolonged proteasome inhibitor-based therapy in these randomized clinical trial ineligible patients. This is important because prolonged proteosome inhibitor-based therapy leads to improved outcomes,” he concluded.—Janelle Bradley
Kambhampti S, Ratnasabapathy R, Thara E, et al. In-Depth Look at a Community- Based Population of Multiple Myeloma (MM) Patients Undergoing an in-Class Transition (iCT) from Parenteral Bortezomib to Oral Ixazomib in the United States (US) MM-6 Study. Presented at: the Virtual 2020 AVAHO Annual Meeting; Sept 12-13, 2020. Abstract 30.
