Active Ingredient: Lenalidomide
Lenalidomide in combination with melphalan and prednisone followed by lenalidomide maintenance in patients who are not eligible for transplant.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 10 milligrams lenalidomide, once daily, 21 doses in total, over the duration of 28 days. This step is repeated 9 times.
Lenalidomide treatment must not be started if the ANC is <1.5 × 109/L, and/or platelet counts are <75 × 109/L.
Recommended dose:
The recommended starting dose is lenalidomide 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles, prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles. Patients who complete 9 cycles or who are unable to complete the combination therapy due to intolerance are treated with lenalidomide monotherapy as follows: 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles given until disease progression.
Dose reduction steps:
| Lenalidomide | Melphalan | Prednisone | |
|---|---|---|---|
| Starting dose | 10 mga | 0.18 mg/kg | 2 mg/kg |
| Dose level -1 | 7.5 mg | 0.14 mg/kg | 1 mg/kg |
| Dose level -2 | 5 mg | 0.10 mg/kg | 0.5 mg/kg |
| Dose level -3 | 2.5 mg | Not applicable | 0.25 mg/kg |
a If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide
Thrombocytopenia:
| When platelets | Recommended course |
|---|---|
| First fall to <25 × 109/L | Interrupt lenalidomide treatment |
| Return to ≥25 × 109/L | Resume lenalidomide and melphalan at dose level -1 |
| For each subsequent drop below 30 × 109/L | Interrupt lenalidomide treatment |
| Return to ≥30 × 109/L | Resume lenalidomide at next lower dose level (dose level -2 or -3) once daily. |
Absolute neutrophil count (ANC) - neutropenia:
| When ANC | Recommended coursea |
|---|---|
| First falls to <0.5 × 109/L | Interrupt lenalidomide treatment |
| Returns to ≥0.5 × 109/L when neutropenia is the only observed toxicity | Resume lenalidomide at starting dose once daily |
| Returns to ≥0.5 × 109/L when dose-dependent haematological toxicities other than neutropenia are observed | 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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