Active Ingredient: Lenalidomide
Lenalidomide as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 10 milligrams lenalidomide, once daily, over the duration of 28 days. This step is repeated 3 times. Afterwards, oral, between 10 milligrams lenalidomide and 15 milligrams lenalidomide, once daily.
Lenalidomide maintenance should be initiated after adequate haematologic recovery following ASCT in patients without evidence of progression. Lenalidomide must not be started if the Absolute Neutrophil Count (ANC) is <1.0 × 109/L, and/or platelet counts are <75 × 109/L.
Recommended dose:
The recommended starting dose is lenalidomide 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
Dose reduction steps:
| Starting dose (10 mg) | If dose increased (15 mg)a | |
|---|---|---|
| Dose level -1 | 5 mg | 10 mg |
| Dose level -2 | 5 mg (days 1-21 every 28 days) | 5 mg |
| Dose level -3 | Not applicable | 5 mg (days 1-21 every 28 days) |
| Do not dose below 5 mg (days 1-21 every 28 days) | ||
a After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
Thrombocytopenia:
| When platelets | Recommended course |
|---|---|
| Fall to <30 × 109/L | Interrupt lenalidomide treatment |
| Return to ≥30 × 109/L | Resume lenalidomide at dose level -1 once daily |
| For each subsequent drop below 30 × 109/L | Interrupt lenalidomide treatment |
| Return to ≥30 × 109/L | Resume lenalidomide at next lower dose level once daily |
Absolute neutrophil count (ANC) - neutropenia:
| When ANC | Recommended coursea |
|---|---|
| Falls to <0.5 × 109/L | Interrupt lenalidomide treatment |
| Returns to ≥0.5 × 109/L | Resume lenalidomide at dose level -1 once daily |
| For each subsequent drop below <0.5 × 109/L | Interrupt lenalidomide treatment |
| Returns to ≥0.5 × 109/L | Resume lenalidomide at next lower dose level once daily |
a At the physician’s discretion, if neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide.
Lenalidomide should be taken orally at about the same time on the scheduled days, either with or without food.
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