Results of a small French study support previous findings that Revlimid in combination with dexamethasone is effective in elderly patients with relapsed multiple myeloma.

Importantly, the researchers found that almost a third of responding patients could remain on therapy following dose adjustments, which, according to the researchers, highlights “the need for a personalized therapeutic approach according to patient age and vulnerability.” 

Revlimid ^[1] (lenalidomide) in combination with dexamethasone ^[2] (Decadron) is a standard therapy for patients with relapsed/refractory multiple myeloma.  Patients are typically prescribed a starting dose of 25 mg of Revlimid, in combination with 40 mg of dexamethasone, in treatment cycles of 21 or 28 days.

According to the French researchers, there is currently limited data available on efficacy and safety of Revlimid in combination with dexamethasone in relapsed patients over the age of 75.  

The two trials that the combination therapy’s approval was based on showed similar efficacy across all patient age groups; however, the number of patients over the age of 75 was small. 

The French researchers therefore retrospectively analyzed data from 45 elderly relapsed myeloma patients who received treatment with Revlimid and dexamethasone between 2006 and 2011 at their institution.  All patients were over the age of 74, with a median age of 79.

Patients had received a median of two prior therapies. All patients had received treatment with alkylating agents such as melphalan ^[3] (Alkeran), 78 percent had received prior thalidomide ^[4] (Thalomid), and more than one third had previously received Velcade ^[5] (bortezomib).   

The patients received 25 mg of Revlimid on days 1 to 21 and 20 mg of dexamethasone weekly during a 28-day treatment cycle. Patients with decreased kidney function, low white blood cell counts, or low platelet counts received a reduced Revlimid dose. The initial Revlimid dose ranged from 10 mg to 25 mg, with a median of 15 mg. Aspirin was administered to all patients for the prevention of blood clots. 

Patients received a median of six treatment cycles.

The researchers found that 62 percent of the patients responded to treatment, with 29 percent achieving a very good partial response or better. According to the French researchers, this response is similar to that observed for elderly patients in the trials that the combination therapy’s approval was based on (64 percent) despite the lower Revlimid doses in the current study.

At a median follow-up time of 18 months, the median progression-free survival time was 14 months and the median estimated overall survival was not yet reached. The researchers pointed out that the progression-free survival time was also similar to that of the previous trials (13 months).

During treatment, 29 percent of patients required Revlimid dose reductions due to low blood cell counts or poor overall health.  Additionally, 51 percent of patients discontinued therapy due to disease progression or side effects.  Seven percent of patients experienced blot clots during treatment, despite preventative treatment with aspirin.   

For more information, please see the study in Leukemia & Lymphoma ^[6] (abstract).