Key points
- Lenalidomide (Revlimid) is a capsule that both kills cancer cells and strengthens the immune system [1].
- It is used for multiple myeloma (with dexamethasone and as continued treatment after a transplant), a type of bone marrow disease (MDS) and some lymphomas [1].
- It has three serious risks: severe harm to an unborn baby, very low white blood cells and platelets, and blood clots and strokes [1].
- Women need 2 negative pregnancy tests before starting and must use 2 methods of contraception at the same time from 4 weeks before to 4 weeks after treatment; men must use condoms [1].
- Continuing lenalidomide after a transplant kept the disease under control more than twice as long and helped patients live longer [5].
What is this drug and how does it work?
For physicians
Lenalidomide (brand name Revlimid) belongs to the immunomodulatory drugs (IMiDs) and is a thalidomide analogue with immunomodulatory, anti-angiogenic and antineoplastic effects [1].
Its main target is the protein cereblon, part of a ubiquitin ligase enzyme complex. In the presence of the drug, proteins such as Ikaros, Aiolos and CK1α are ubiquitinated and degraded, leading to direct cytotoxicity against cancer cells and immune enhancement [1]. Lenalidomide increases the number and activity of T cells and natural killer (NK) cells, and its combination with dexamethasone or rituximab strengthens the antitumour effect [1].
Lenalidomide has been used in major multiple myeloma trials such as MAIA, PERSEUS and IMROZ with anti-CD38 antibodies and bortezomib [2, 3, 4].
Which cancers is it used for?
Your doctor may prescribe this drug for:
- Multiple myeloma (newly diagnosed or come back) [1, 2, 4]
- Multiple myeloma suitable for a transplant [3]
- Multiple myeloma after an autologous transplant [1, 5]
- Myelodysplastic syndrome (MDS) with 5q deletion [1, 6]
- Mantle cell lymphoma (MCL) [1]
- Follicular lymphoma (FL) and marginal zone lymphoma (MZL) [1, 7]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Setting | Key evidence |
|---|---|---|
| Multiple myeloma (newly diagnosed or relapsed) | With dexamethasone and in combination regimens [1] | MAIA: adding daratumumab to lenalidomide and dexamethasone raised 30-month progression-free survival from 55.6% to 70.6% (HR 0.56) [2]; IMROZ: 60-month progression-free survival 63.2% with isatuximab + VRd vs 45.2% with VRd (HR 0.60) [4] |
| Transplant-eligible multiple myeloma | Part of induction and consolidation (such as D-VRd) and then maintenance [3] | PERSEUS: 48-month progression-free survival 84.3% with D-VRd and daratumumab + lenalidomide maintenance vs 67.7% with VRd and lenalidomide maintenance (HR 0.42) [3] |
| Multiple myeloma after autologous transplant | Maintenance treatment [1] | Meta-analysis of 3 trials (1208 patients): median progression-free survival 52.8 vs 23.5 months (HR 0.48); HR for overall survival 0.75 [5] |
| Myelodysplastic syndrome (MDS) with 5q deletion | Transfusion-dependent anaemia in low- or intermediate-1-risk MDS [1] | 67% of patients (99 of 148) no longer needed transfusions [6] |
| Mantle cell lymphoma (MCL) | Relapse or progression after 2 prior therapies, one including bortezomib [1] | Single-arm trial in the label: overall response 26%; median duration of response 16.6 months [1] |
| Follicular lymphoma (FL) and marginal zone lymphoma (MZL) | Previously treated, with rituximab (up to 12 cycles) [1] | AUGMENT: median progression-free survival 39.4 vs 14.1 months with rituximab + placebo; HR 0.46 [7] |
Lenalidomide is not approved for CLL and is not recommended outside a clinical trial, because in one trial it increased mortality compared with chlorambucil [1].
How it is taken and dosing
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Treatment regimens and doses: index6 regimens
- Swallow the capsule once a day, at about the same time, with or without food, whole with water; do not open, break or chew it, and handle it as little as possible. If the capsule powder touches your skin, wash it straight away with soap and water [1].
- In many regimens the drug is taken for 21 days of each 28-day cycle with 7 days off; in maintenance it is usually taken every day without a break [1].
- If you miss a dose and less than 12 hours have passed since the usual time, take it; if more than 12 hours have passed, skip it and take your usual dose the next day. Never take two doses together [1].
- Lenalidomide is prescribed and dispensed only through a special safety programme (REMS), and you must sign a patient–doctor agreement form [1].
- Do not share the drug with others, and do not stop it or change the dose without your doctor's advice [1].
- Before starting (REMS): only through the Lenalidomide REMS programme; the schedule of pregnancy tests, two contraceptive methods in women, condoms in men and the ban on sperm and blood donation until 4 weeks after stopping, together with a thyroid check before starting, are in Interactions, pregnancy and precautions [1]. History of grade 4 rash with thalidomide: contraindicated [1].
- Thromboprophylaxis: recommended; the choice is based on the patient's risk factors (mostly aspirin in the newly diagnosed trial) [1].
- Dose modification in myeloma (combination): platelets below 30,000 per µL: hold and check CBC weekly; once 30,000 or more, resume one dose level lower. Neutrophils below 1000: hold; once recovered to 1000 or more, resume at 25 mg (or the starting dose) if neutropenia is the only toxicity, otherwise one level lower; for each further fall, one level lower. Do not go below 2.5 mg daily [1]. Maintenance: thresholds of 30,000 platelets and 500 neutrophils; resume one level lower; at 5 mg, continue at 5 mg on days 1 to 21 (do not go lower) [1].
- Grade 3 to 4 non-haematological toxicity: hold and, after recovery to grade 2 or lower, resume one level lower. Discontinue permanently for angioedema, anaphylaxis, grade 4 rash, exfoliative or bullous rash, SJS/TEN/DRESS. Raised liver enzymes: hold and, after return to baseline, a lower dose may be considered. Grade 3 to 4 tumour flare reaction: hold until grade 1 or lower [1].
- Renal impairment (Cockcroft-Gault): creatinine clearance 30 to 60: 10 mg once daily in myeloma (combination), MCL and FL/MZL (after 2 cycles, 15 mg if tolerated in myeloma and FL/MZL); 5 mg in maintenance and MDS. Below 30 without dialysis: 15 mg every other day (myeloma/MCL), 5 mg daily (FL/MZL), 2.5 mg daily (maintenance/MDS). On dialysis: 5 mg daily (2.5 mg in maintenance/MDS), after dialysis on dialysis days [1].
- CBC monitoring: myeloma (combination or maintenance): weekly for the first 2 cycles, on days 1 and 15 of cycle 3, then every 4 weeks. MDS: weekly for the first 8 weeks, then at least monthly. MCL: weekly in cycle 1, every 2 weeks in cycles 2 to 4, then monthly. FL/MZL: weekly for the first 3 weeks of cycle 1, every 2 weeks in cycles 2 to 4, then monthly [1]. Also liver enzymes periodically and monitoring for second primary malignancies [1].
For physicians
Standard dosing (FDA label)
Newly diagnosed multiple myeloma, not a transplant candidate (Rd)
With low-dose dexamethasoneCycle length: Every 28 days
With low-dose dexamethasone [1]
Before prescribing: Prescribing notes: REMS, dose modification and monitoring| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Each cycle | |||
| Lenalidomide | 25 mg | Oral (with or without food) | Days 1 to 21 |
| Dexamethasone | 40 mg (over 75 years: 20 mg) | Oral | Days 1, 8, 15 and 22 |
In transplant candidates, collect stem cells within 4 cycles of lenalidomide-containing treatment [1].
Multiple myeloma after at least one prior therapy (Rd with pulsed dexamethasone)
With dexamethasoneCycle length: Every 28 days
With dexamethasone [1]
Before prescribing: Prescribing notes: REMS, dose modification and monitoring| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Each cycle | |||
| Lenalidomide | 25 mg | Oral (with or without food) | Days 1 to 21 |
| First 4 cycles | |||
| Dexamethasone | 40 mg | Oral | Days 1 to 4, 9 to 12 and 17 to 20 |
| From cycle 5 | |||
| Dexamethasone | 40 mg | Oral | Days 1 to 4 |
Successive lenalidomide dose reductions in the studies: 15, 10 and 5 mg [1].
Multiple myeloma, maintenance after autologous transplant
After adequate haematological recovery (neutrophils at least 1000 and/or platelets at least 75,000 per µL)Cycle length: Every 28 days
After adequate haematological recovery (neutrophils at least 1000 and/or platelets at least 75,000 per µL) [1]
Before prescribing: Prescribing notes: REMS, dose modification and monitoring| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Lenalidomide | 10 mg (after 3 cycles, 15 mg if tolerated) | Oral (with or without food) | Days 1 to 28 (no break) |
MDS with 5q deletion
Transfusion-dependent anaemia in low- or intermediate-1-risk MDSCycle length: Continuous
Transfusion-dependent anaemia in low- or intermediate-1-risk MDS [1]
Before prescribing: Prescribing notes: REMS, dose modification and monitoring| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Lenalidomide | 10 mg | Oral (with or without food) | Once daily, every day |
Thrombocytopenia or neutropenia: hold and resume at 5 mg; at 5 mg, resume at 2.5 mg (thresholds depend on the baseline value and timing, as in the label table) [1].
Relapsed or refractory mantle cell lymphoma
After 2 prior therapies, one of which included bortezomibCycle length: Every 28 days
After 2 prior therapies, one of which included bortezomib [1]
Before prescribing: Prescribing notes: REMS, dose modification and monitoring| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Each cycle | |||
| Lenalidomide | 25 mg | Oral (with or without food) | Days 1 to 21 |
Platelets below 50,000, or neutrophils below 1000 for at least 7 days, with a fever of 38.5 °C or more, or below 500: hold and check CBC weekly; after recovery (platelets 50,000 or more / neutrophils 1000 or more), 5 mg less than the previous dose; do not go below 5 mg daily [1].
Previously treated follicular or marginal zone lymphoma (R2, AUGMENT regimen)
With rituximabCycle length: Every 28 days
With rituximab [1]
Before prescribing: Prescribing notes: REMS, dose modification and monitoring| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Up to 12 cycles | |||
| Lenalidomide | 20 mg | Oral (with or without food) | Days 1 to 21 |
| Cycle 1 | |||
| Rituximab | 375 mg/m² | IV | Days 1, 8, 15 and 22 |
| Cycles 2 to 5 | |||
| Rituximab | 375 mg/m² | IV | Day 1 |
Haematological dose modification as for mantle cell lymphoma (5 mg less; do not go below 5 mg, or below 2.5 mg if the starting dose was 10) [1].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
For physicians
| Adverse reaction | Newly diagnosed multiple myeloma: continuous lenalidomide + dexamethasone (532 patients) | MDS with 5q deletion: lenalidomide 10 mg (148 patients) |
|---|---|---|
| Diarrhoea | 45% [1] | 48.6% [1] |
| Neutropenia | 35% [1] | 58.8% [1] |
| Thrombocytopenia | 20% [1] | 61.5% [1] |
| Fatigue | 33% [1] | 31.1% [1] |
| Rash | 26% [1] | 35.8% [1] |
| Pruritus | 9% [1] | 41.9% [1] |
| Anaemia | 44% [1] | Not in this list |
| Insomnia | 28% [1] | Not in this list |
| Back pain | 32% [1] | Not in this list |
| Deep vein thrombosis (DVT) | 10% [1] | Not in this list |
The myeloma data come from the large phase 3 trial in newly diagnosed patients (lenalidomide and dexamethasone until disease progression arm) in the FDA label. In maintenance after transplant, grade 3 or 4 neutropenia was reported in up to 59% and grade 3 or 4 thrombocytopenia in up to 38% [1]. In follicular and marginal zone lymphoma (with rituximab), the most common adverse reactions were neutropenia (48%), fatigue (37%), diarrhoea (32%), constipation (27%), nausea (21%) and cough (20%) [1].
Serious side effects
These are less common but serious; tell your team early if you notice any sign of them:
- Severe harm to an unborn baby: it must not be used in pregnancy; women and men must use reliable contraception as their doctor directs [1].
- Blood clots in the leg or lung, and heart attack or stroke: pain and swelling in one leg, sudden shortness of breath or chest pain; a medicine to prevent clots is usually given [1].
- Infection or bleeding because of low blood counts: fever, bruising [1].
- Liver damage and severe skin or allergic reactions (blisters, facial swelling) [1].
- A small rise in the risk of other cancers in later years; even so, the benefit of the drug outweighs this risk [1, 5].
For physicians
Boxed warnings
- Embryo-fetal toxicity: lenalidomide caused limb defects similar to thalidomide in a monkey study and is contraindicated in pregnancy. This is why it is available only through the restricted Lenalidomide REMS programme [1].
- Haematological toxicity: severe neutropenia and thrombocytopenia; in the pivotal MDS trial, 80% of patients needed a dose delay or reduction and grade 3 or 4 haematological toxicity occurred in 80% [1].
- Venous and arterial thromboembolism: the risk of deep vein thrombosis and pulmonary embolism, and of myocardial infarction and stroke, is significantly increased in myeloma patients treated with lenalidomide and dexamethasone; in relapsed myeloma, DVT occurred in 7.4% and pulmonary embolism in 3.7% vs 3.1% and 0.9% with placebo and dexamethasone. Thromboprophylaxis is recommended [1].
Other warnings
- Second primary malignancies: including AML and MDS; in maintenance after high-dose melphalan and transplant, haematological second malignancies occurred in 7.5% vs 3.3% with placebo [1]. In the maintenance meta-analysis, second cancers before progression were also more common, although the survival benefit remained [5].
- Hepatotoxicity: including fatal hepatic failure; 15% of patients in trials had hepatotoxicity [1].
- Severe cutaneous reactions (SJS, TEN and DRESS) and hypersensitivity reactions such as angioedema and anaphylaxis [1].
- Tumour lysis syndrome and tumour flare reaction (painful lymph node swelling, low-grade fever, pain and rash); tumour flare was seen in 10% of MCL patients [1].
- Impaired stem cell mobilisation after more than 4 cycles, thyroid disorders, and increased early mortality in MCL [1].
- Adding pembrolizumab to a thalidomide analogue and dexamethasone in myeloma increased mortality and is not recommended outside a trial [1].
When should I call my doctor?
- Signs of a clot: shortness of breath, chest pain, or swelling of an arm or leg — go to the emergency department straight away [1].
- Signs of a heart attack or stroke [1].
- Fever or any sign of infection; unusual bruising or bleeding [1].
- Yellow skin or whites of the eyes, dark (tea-coloured) urine, pain in the upper right abdomen or severe tiredness [1].
- A red, itchy rash, blistering or peeling skin; swelling of the lips, mouth, tongue or throat, or trouble breathing or swallowing (an emergency) [1].
- Painful swollen lymph nodes with a low fever, pain or rash [1].
- A late period, unusual menstrual bleeding or a suspected pregnancy — stop the drug and tell your doctor straight away [1].
Interactions, pregnancy and precautions
- REMS programme and pregnancy: women who could become pregnant must have 2 negative pregnancy tests (the first 10 to 14 days and the second 24 hours before the prescription), then weekly tests for the first 4 weeks and then every 4 weeks (every 2 weeks if periods are irregular) [1].
- Contraception for women: either complete and continuous abstinence from heterosexual sex, or 2 methods at the same time (one highly effective method such as an IUD, hormonal contraception, tubal ligation or a partner's vasectomy, plus another effective method such as a condom) from 4 weeks before starting, during treatment and breaks, and until 4 weeks after stopping the drug [1].
- Men: lenalidomide passes into semen; use a latex or synthetic condom every time you have sex with a woman who could become pregnant, during treatment and for 4 weeks after stopping the drug, even if you have had a vasectomy, and do not donate sperm [1].
- Blood donation: do not donate blood during treatment and for 4 weeks after stopping the drug [1].
- Breastfeeding: do not breastfeed during treatment [1].
- Drugs that increase clot risk: blood cell growth factors (such as erythropoietin) and oestrogen-containing medicines (such as combined contraceptive pills) increase the risk of clots and should be used only after weighing benefit and risk. Control modifiable factors such as smoking, high blood pressure and high cholesterol [1].
- Interactions: with digoxin, monitor digoxin levels; with warfarin, monitor PT and INR closely [1].
- Thyroid: thyroid function should be checked before starting and during treatment [1].
Frequently asked questions
Why do I need so many forms and tests to get lenalidomide?
Because lenalidomide is a thalidomide analogue and can cause severe birth defects. The REMS programme makes sure no unborn baby is exposed to the drug; this is why the doctor, the pharmacy and the patient must all enrol in the programme and follow the pregnancy testing and contraception rules [1].
Do I also need to take an anticoagulant?
The FDA label recommends clot prevention for patients treated with lenalidomide, and your doctor chooses the type (such as aspirin or anticoagulants) based on your risk factors [1].
How long does lenalidomide maintenance last?
According to the label, maintenance after a transplant continues until the disease progresses or side effects cannot be tolerated [1]. In a review of several studies, this treatment both kept the disease under control longer and helped patients live longer [5]. Review the right length with your doctor.
What should I do if I forget a dose?
If less than 12 hours have passed, take the dose; if more than 12 hours have passed, skip it and take the next dose at the usual time. Do not take two doses together [1].
Does lenalidomide raise the risk of another cancer?
Key studies
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Key studies
4 itemsInternational Myeloma Working Group updated criteria for the diagnosis of multiple myeloma
Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma
Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma
Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma
Related cancer types
Treatment regimens (physicians)
References
7 referencesShow all references, 6 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1REVLIMID (lenalidomide) capsules, for oral use — Prescribing InformationSource Back to text: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106
- 2
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- 5
- 6Lenalidomide in the Myelodysplastic Syndrome with Chromosome 5q Deletion
- 7AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
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