Preliminary findings showed that Revlimid (lenalidomide) significantly prolonged progression-free survival compared with observation in patients with smoldering multiple myeloma.
Patients with smoldering myeloma treated with Revlimid (lenalidomide) monotherapy achieved a statistically significant improvement in progression-free survival compared with those who were observed, according to preliminary findings of the ECOG E3A06 study.
Smoldering multiple myeloma is an early precursor to multiple myeloma and produces certain proteins — measured in the blood and urine – that show up before a person has any symptoms. Most people with smoldering multiple myeloma eventually develop myeloma, which is why patients are closely monitored by their doctors.
“A portion of patients with smoldering myeloma do progress to clinical myeloma, which requires significantly more therapy,” Madhav Dhodapkar, principal investigator of the Yale University cohort of the trial and clinical research program leader in the Hematology Program at Yale Cancer Center, said in a May 2016 interview with CURE.
“It is very important for us to know if using Revlimid early on will actually prevent progression to clinical myeloma, and actually lead to improved outcomes. If it does, it will change the standard of care,” he added.
In the randomized phase 3 ECOG E3A06 study, led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute, researchers are evaluating the safety and efficacy of the investigational use of Revlimid monotherapy compared with observation in patients with asymptomatic high-risk smoldering multiple myeloma.
In the treatment arm, patients received Revlimid orally once daily on days one through 21 for every 28-day cycle until disease progression or unacceptable toxicity. The control arm underwent observation until progression to symptomatic myeloma.
Single-agent Revlimid demonstrated a significant improvement in progression-free survival (the time that a patient lives with the disease but it does not get worse) — the study’s primary endpoint – compared with observation. Secondary outcomes will include overall response rate, duration of response, overall survival and safety.
In addition, the safety profile appeared to be consistent with previous studies.
“In multiple myeloma, there has been an important question regarding the risks and benefits of treating patients with smoldering myeloma. We believe that the properties of Revlimid could play an important role in delaying the progression of smoldering myeloma into active myeloma,” Jay Backstrom, chief medical officer for Celgene, the agent’s manufactuere, said in a press release.
Celgene noted that data from the study will be presented at a future medical meeting.