Jose WM, et al. - In patients newly diagnosed with multiple myeloma who were ineligible for or unwilling to undergo transplantation and who were treated with a combination of lenalidomide and low-dose dexamethasone for a fixed 6 cycles in a resource-constrained environment, researchers determined response to treatment, toxicity, time to progression, progression-free survival, and overall survival. They recognized lenalidomide with low-dose dexamethasone as an effective treatment with acceptable toxicity in these patients. In contrast to the reports from Western literature, complete responses were significantly more frequent. Hyperglycemia was common, but occurrence of clinical deep-vein thrombosis was rare. In multiple myeloma, an abbreviated course of treatment seemed suboptimal. They advocated maintenance regimens.

Methods

• Researchers conducted this pragmatic study in a single tertiary cancer centre in South India.
• They enrolled patients from May 2009 till April 2011.
• With dexamethasone 40 mg on days 1, 8, 15, and 22 of a 28-day cycle, treatment included lenalidomide 25 mg daily for 21 days for 6 cycles.
• They evaluated response after the 3rd and 6th cycles of treatment.
• They followed up all patients for 5 years .

Results

• Enrollment of 51 patients was performed; median age was 61 years (range: 38–76 years).
• In this study, immunoglobulin G or A myeloma constituted 70.6% of the diagnoses, and light-chain myeloma constituted 29.4%.
• As per observations, 21.4%, 28.6%, and 50% of the diagnoses were constituted of stages i, ii, and iii (International Staging System) disease, respectively.
• For economic reasons, 34 (66.7%) out of all eligible patients refused transplantation.
• After treatment, a stringent complete response was observed in 19.6% of the patients; complete response in 35.3%; a very good partial response in 5.9%; and a partial response in 29.4%, for an overall response rate of 90.2%.
• In 3.9% patients, stable disease was observed, and 5.9% indicated progressive disease.
• Grade 3 or greater nonhematologic and hematologic toxicity occurred in 35.2% and 11.7% of patients respectively.
• One patient suffered pulmonary embolism.
• They observed no patient who experienced deep-vein thrombosis or peripheral neuropathy.
• For a median duration of 66 months, follow-up was performed.
• Disease progression was experienced by all the pateints.
• Observations revealed median progression-free survival of 16 months.
• Re-challenge with lenalidomide and dexamethasone resulted in achieving a second complete response in 10 patients.
• 19 deaths were reported at the time of writing.
• At 5 years, the overall survival rate was 62.74%.
• Median overall survival was yet to be reached.