Revlimid in combination with dexamethasone was first approved by the U.S. Food and Drug Administration (FDA) in 2006 for multiple myeloma patients who have had at least one prior treatment.
The approval was further expanded in 2015 for use in combination with dexamethasone to treat multiple myeloma patients who are not eligible for autologous hematopoietic stem cell transplant (AHSCT).
The FDA again expanded Revlimid’s label in 2017 to include it as a maintenance therapy for multiple myeloma patients who have undergone AHSCT.
How does Revlimid work?
The exact mechanism of action of Revlimid is still being studied.
Researchers know that Revlimid targets myeloma cells by binding to a specific protein called cereblon, which is involved in regulating the activity of proteins related to cell adhesion, metabolism, and cell division. The binding of Revlimid to cereblon triggers the death of cancer cells as it affects the above processes.
Revlimid in clinical trials
Revlimid has been extensively studied in several clinical trials in patients with newly diagnosed multiple myeloma, those being treated with AHSCT, and those who have had at least one prior therapy.
In these studies, the Revlimid-dexamethasone combination shortened the time to progression, meaning the length of time before myeloma symptoms worsen. The overall response rate was also high.
Revlimid was also effective in improving progression-free survival time, referring to the duration of time a patient lives before the disease worsens, by 3.8 years in patients who took it as maintenance therapy following AHSCT.
Revlimid, in combination with high-dose chemotherapy (Velcade) and dexamethasone (collectively referred to as RVD), was evaluated in a Phase 3 clinical trial (NCT01191060) with and without AHSCT in newly diagnosed multiple myeloma patients to determine whether high-dose chemotherapy is needed in the initial management of the disease in younger patients.
Study results indicated that the combination of RVD with AHSCT led to longer progression-free survival times than RVD alone, even though the overall survival did not vary much between the two approaches.
Revlimid is currently being evaluated in a Phase 3 clinical trial (NCT01169337) in 180 participants with asymptomatic high-risk (smoldering) multiple myeloma — an intermediary stage between monoclonal gammopathy of undermined significance (MGUS) and multiple myeloma. The study will be helpful in understanding whether Revlimid can prevent the progression of smoldering multiple myeloma into multiple myeloma. It is expected to be completed in March 2020.
Common side effects of the Revlimid-dexamethasone combination include fatigue, low blood cell counts, shortness of breath, insomnia, muscle spasms, fever, and rash. Similar common side effects are seen when Revlimid is taken as maintenance therapy following AHSCT.
Severe side effects of the combo treatment include cataracts, kidney failure, hypokalemia (low potassium levels in the blood), pneumonia, and thrombosis (formation of blood clots inside blood vessels).
Diarrhea, low phosphate and potassium levels in the blood, infection, and pneumonia have been reported as severe side effects for those taking Revlimid as a maintenance therapy.
Last updated: Nov. 11, 2019
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