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Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma
Christine Chen1, Donna E Reece, David Siegel
1Princess Margaret Hospital, Toronto, ON, Canada.
British Journal of Haematology
|June 24, 2009
Summary
Lenalidomide combined with dexamethasone showed manageable safety in relapsed/refractory multiple myeloma patients through an expanded access program. This study confirmed known adverse events, with disease progression being the primary cause of death.
Area of Science:
- Hematology
- Oncology
- Clinical Pharmacology
Background:
- Lenalidomide received FDA approval for relapsed/refractory multiple myeloma (MM) in June 2006.
- An expanded access program was initiated in April 2005 to provide lenalidomide and gather safety data.
Purpose of the Study:
- To evaluate the safety and tolerability of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma.
- To collect additional safety information during the expanded access program.
Main Methods:
- 1438 patients with relapsed/refractory MM received lenalidomide (25 mg/d) and dexamethasone.
- Treatment was administered in 4-week cycles until disease progression or drug discontinuation.
- Data on adverse events, serious adverse events, and causes of death were collected.
Main Results:
- The most common adverse events included hematological issues (49%), gastrointestinal problems (59%), and fatigue (55%).
- Grade >=3 adverse events were primarily hematological (45%), fatigue (10%), and pneumonia (7%).
- Serious adverse events included pneumonia (8%), pyrexia (4%), and deep-vein thrombosis (3%). Disease progression was the main cause of death (10%).
Conclusions:
- The safety profile of lenalidomide plus dexamethasone in this expanded access program was consistent with known adverse events.
- The program provided valuable safety data for lenalidomide treatment in relapsed/refractory multiple myeloma patients.
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