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Lenalidomide is a medicine used for the treatment of multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma, which are conditions affecting blood cells and bone marrow.

In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide is used:

on its own, in adults who have had a stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from a donor) to stop the progression of the cancer;
in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have stem cell transplantation;
in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have stem cell transplantation;
in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
In myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Lenalidomide is used for patients who need blood transfusions to manage their anaemia. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells). Lenalidomide is used in patients who have a genetic abnormality (called deletion 5q) and are at a lower risk of AML, and it is used when other treatments are not adequate.

In mantle cell lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide is used in adults whose disease has come back after treatment, or does not improve with treatment.

Lenalidomide maintenance therapy after autologous stem-cell transplantation (ASCT) demonstrated prolonged progression-free survival (PFS) versus placebo or observation in several randomized controlled trials (RCTs) of patients with newly diagnosed multiple myeloma (NDMM). All studies had PFS as the primary end point, and none were powered for overall survival (OS) as a primary end point. Thus, a meta-analysis was conducted to better understand the impact of lenalidomide maintenance in this setting.

The meta-analysis was conducted using primary-source patient-level data and documentation from three RCTs (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell’Adulto RV-MM-PI-209, and Intergroupe Francophone du Myélome 2005-02) that met the following prespecified inclusion criteria: an RCT in patients with NDMM receiving ASCT followed by lenalidomide maintenance versus placebo or observation with patient-level data available and achieved database lock for primary efficacy analysis.

Overall, 1,208 patients were included in the meta-analysis (605 patients in the lenalidomide maintenance group and 603 in the placebo or observation group). The median PFS was 52.8 months for the lenalidomide group and 23.5 months for the placebo or observation group (hazard ratio, 0.48; 95% CI, 0.41 to 0.55). At a median follow-up time of 79.5 months for all surviving patients, the median OS had not been reached for the lenalidomide maintenance group, whereas it was 86.0 months for the placebo or observation group (hazard ratio, 0.75; 95% CI, 0.63 to 0.90; P = .001). The cumulative incidence rate of a second primary malignancy before disease progression was higher with lenalidomide maintenance versus placebo or observation, whereas the cumulative incidence rates of progression, death, or death as a result of myeloma were all higher with placebo or observation versus lenalidomide maintenance.

Lenalidomide is available as capsules (5 mg, 10 mg, 15 mg, and 25 mg) to be taken by mouth. The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.

Lenalidomide is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days. Depending on the day, the patient may take one or more medicines or may not take any medicines.

The dose depends on the disease Lenalidomide is used to treat. The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection). A lower dose should be used in patients who have moderate or more severe reduction in their kidney function.

Important things to remember about the side effects of Lenalidomide:

• You will not get all of the side effects mentioned below.
• Side effects are often predictable in terms of their onset, duration, and severity.
• Side effects are almost always reversible and will go away after therapy is complete.
• Side effects are quite manageable. There are many options to minimize or prevent them.

The following side effects are common (occurring in greater than 30%) for patients taking Lenalidomide:

• Low blood counts . Your white blood cells and platelets may temporarily decrease. This can put you at increased risk for infection and/or bleeding.  Blood counts are monitored closely and dose adjustments may be necessary.
• Diarrhea
• Itching
• Rash
• Fatigue, tiredness

These are less common side effects for patients receiving Lenalidomide:

• Constipation
• Nausea
• Sore throat
• Generalized aches and pains
• Fever
• Back pain
• Swelling of ankles or feet
• Cough
• Dizziness
• Headache
• Muscle cramps
• Shortness of breath
• Generalized weakness
• Nose bleed
• Infection
• Dry skin
• Anemia (low red blood cell count)
• Pneumonia
• Low potassium
• Difficulty sleeping
• Poor appetite
• Vomiting

A rare, but serious side effect of Lenalidomide is blood clots, including deep vein thrombosis (DVT) and pulmonary embolus (PE).  You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath.  Notify your health care provider within 24 hours if you notice leg or arm swelling, redness, pain and/or skin warm to touch (signs and symptoms of possible blood clot)..

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.