Recent prospective multicenter phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15mg) and dexamethasone (20mg) in frail patients with relapsed or refractory MM. The overall response rate was 71% including complete remission of 15%. Median progression free survival and overall survival were 8.9 and 30.5 months. In addition, grade 3-4 toxicities such as neutropenia, and infections were reduced. This study supported that lower dose lenalidomide may be optimal stating dose for elderly patients with frailty.
Multiple myeloma (MM) is a malignant plasma cell disorder that occurs mainly in older adults. The median age at diagnosis is approximately 70 years, and two-thirds of patients with newly diagnosed MM are older than 65years. As life expectancy increases, the population of older individuals grows. Consequently, the number of patients with MM, especially elderly patients, is expected to increase considerably in the next two decades. Elderly patients may have a variety of comorbidities and reduced physical function at diagnosis, and may be intolerable to standard chemotherapy. Recent prospective multicenter phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15mg) and dexamethasone (20mg) in frail patients with relapsed or refractory MM\[8\]. The overall response rate was 71% including complete remission of 15%. Median progression free survival and overall survival were 8.9 and 30.5 months. In addition, grade 3-4 toxicities such as neutropenia, and infections were reduced. This study supported that lower dose lenalidomide may be optimal stating dose for elderly patients with frailty. Therefore, investigators thought that the use of lower dose of lenalidomide in the frail group is expected to increase the effectiveness as it is used for a long time while reducing toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
-high dose: \[lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly\] -Low dose: \[lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly\]
-high dose: \[lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly\] -Low dose: \[lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly\]
Kosin University Gospel Hospital
Busan, Western, South Korea
2 years Progression Free Survival rates
To evaluate the progression free survival rates at 2 years
Time frame: 2year
2 years Event-free survival rates
To evaluate the event free survival rates at 2 years
Time frame: 2year
2 years Overall Survival rates
To evaluate the overall survival rates at 2 years
Time frame: 2year
Overall response rates
To evaluated the overall response rates, defined as more than partial response.
Time frame: assessed for approximately 2 years after administration
Incidence of Treatment-Emergent Adverse Events by CTCAE
To assess the incidence of lenalidomide plus dexamethasone therapy
Time frame: assessed for approximately 2 years after administration
Optimal dose in frail patients
To assess the optimal dose of lenalidomide for frail patients with newly diagnosed multiple myeloma.
Time frame: through study completion, an average of 1 year
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