New Regimen Highly Effective in Multiple Myeloma Patients

Carfilzomib, pomalidomide, and dexamethasone regimen safe and well tolerated during recent study.

An experimental treatment option for multiple myeloma may soon offer a new option for patients suffering from the disease.

Treatment options for patients with heavily pretreated relapsed and/or refractory multiple myeloma (RRMM) remain scarce. A recent study evaluated a new therapeutic regimen that consists of carfilzomib, pomalidomide, and dexamethasone.

Findings indicate the regimen is well-tolerated and highly active in patients with RRMM.

The open-label, multicenter, phase 1, dose-escalation study evaluated patients that relapsed after prior therapy or were refractory to the most recently received therapy.

Patients were required to have had a diagnosis of multiple myeloma that relapsed after prior therapy or was refractory to the most recently received therapy in order to be considered for enrollment.

The multicenter, phase 1, open-label, dose-finding study was designed to evaluate the safety and determine the maximum tolerated dose of carfilzomib, pomalidomide, and dexamethasone (CPD) in patients with RRMM.

Secondary endpoints to the study were to analyze the preliminary efficacy of CPD measuring the overall response rate (ORR), time to progression, progression free survival, and overall survival.

Scientists recorded responses to treatment on day 15 of the first cycle and on day 1 of all subsequent cycles. Safety analyses were conducted in all patients who received at least 1 dose of study treatment.

Overall, there were 32 patients with RRMM enrolled in 8 centers in the United States. Of the 32 patients enrolled, 2 were removed from the study for different reasons related to hypercalcemia.

These patients did not receive adequate therapy levels but were included in the intent to treat response evaluation. The remaining patients received at least 2 full cycles of study therapy.

Of the 32 patients enrolled, 28 had adverse events related to the study treatment or an infection. Approximately 63% of patients had any grade 3 event, 31% of patients had grade 4 events, and 2 patients had a fatal event of either pneumonia or pulmonary embolism.

Based on the results of the study, researchers were able to ascertain that the regimen is well-tolerated and highly active in patients with RRMM. This is an important finding as there are limited treatment options available to patients with the disease.

The promising ORR and durable responses seen in patients, regardless of risk stratification, support further clinical trials of the combination in earlier lines of therapy as well as in high-risk myeloma. The combination may also lead the way in providing a backbone for additional anti-myeloma therapies.