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Myelodysplastic syndrome lenalidomide

Patients with myelodysplastic syndrome should be considered for inclusion into clinical trials. Link to ALLG website and ANZCTR website.

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Cycle 1 and further cycles

Drug Dose Route Day
Lenalidomide 10 mg ONCE a day PO 1 to 21
Frequency:
28 days 
Cycles:
Continuous until disease progression or unacceptable toxicity
Notes:

Consider disease reassessment with bone marrow biopsy at weeks 12 and 24 and every 24 weeks thereafter.r

Drug status:

Lenalidomide (PBS authority opens in a new tab or window)

NB: patient registration into a pregnancy prevention risk management program is required.

Full prescribing information and Authority Application forms available from the Department of Human Services opens in a new tab or window website

Lenalidomide is available as 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules

Cost:
~ $820 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 and further cycles

Day 1 to 21
Lenalidomide 10 mg (PO) ONCE a day. Take at same time each day, either with or without food.
Frequency:
28 days 
Cycles:
Continuous until disease progression or unacceptable toxicity

Cycle 1 and further cycles

Drug Dose Route Day
Lenalidomide 10 mg ONCE a day PO 1 to 21
Frequency:
28 days 
Cycles:
Continuous until disease progression or unacceptable toxicity
Notes:

Consider disease reassessment with bone marrow biopsy at weeks 12 and 24 and every 24 weeks thereafter.r

Drug status:

Lenalidomide (PBS authority opens in a new tab or window)

NB: patient registration into a pregnancy prevention risk management program is required.

Full prescribing information and Authority Application forms available from the Department of Human Services opens in a new tab or window website

Lenalidomide is available as 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules

Cost:
~ $820 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 and further cycles

Day 1 to 21
Lenalidomide 10 mg (PO) ONCE a day. Take at same time each day, either with or without food.
Frequency:
28 days 
Cycles:
Continuous until disease progression or unacceptable toxicity
  • Transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Caution with oral anti-cancer drugs

Select links for information on the safe prescribing, dispensing and administration of orally administered anti-cancer drugs. 

Read more about at COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer therapy opens in a new tab or window and oral anti-cancer therapy opens in a new tab or window
Emetogenicity minimal or low

No routine prophylaxis required. If patients experience nausea and/or vomiting, consider using the low emetogenic risk regimen.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Teratogenic effects

Immunomodulatory drugs (IMiDs) include thalidomide, lenalidomide and pomalidomide. They can cause severe congenital disabilities or death to an unborn baby when taken during pregnancy.  

All patients and partners of patients that can conceive a child must use at least one reliable contraceptive method for at least 4 weeks before starting treatment, during treatment (including dose interruptions), and for 4 weeks after stopping treatment. 
Male patients should also use a condom when having sexual intercourse with a woman of childbearing potential during treatment (including dose interruptions), and for 4 weeks after stopping treatment.
In female patients and female partners of male patients, a pregnancy test should be carried out prior to initiating treatment (after 4 weeks of contraception use), weekly during the first month of treatment and monthly thereafter.
Effective contraception methods and adequate contraception timeframes should be discussed with all patients of reproductive potential.
Prescription of an IMiD requires patient registration with a pregnancy prevention program.

Full prescribing information and Authority Application forms available from the Department of Human Services website opens in a new tab or window
Thromboembolism

Venous thromboembolic events have been observed in patients with this treatment. 
PJP prophylaxis

PJP prophylaxis at the discretion of the treating clinician. 

Read more about prophylaxis of pneumocystis jiroveci (carinii) in cancer patients
Antiviral prophylaxis

­

Read more about antiviral prophylaxis drugs and doses
Antifungal prophylaxis ­

Read more about antifungal prophylaxis drugs and doses.
Growth factor support

G-CSF (short or long-acting) is available on the PBS for chemotherapy induced neutropenia depending on clinical indication and/or febrile neutropenia risk.  

Access the PBS website opens in a new tab or window
Blood tests

FBC, EUC, eGFR, LFTs, calcium, magnesium, phosphate, TSH and BSL at baseline. Repeat FBC weekly for the first two months, then monthly or as clinically indicated. Continue to monitor EUC, eGFR, LFTs, calcium, magnesium, phosphate, TSH and BSL regularly throughout treatment, or as clinically indicated.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is recommended prior to initiation of treatment. Prophylaxis should be determined according to individual institutional policy.

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease. Possible suboptimal response to inactivated vaccines.

For more information about vaccinations in people with cancer refer to the Australian Immunisation Handbook opens in a new tab or window.
Fertility and lactation

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive potential prior to commencing treatment.

Possibility of infant risk should be discussed with breastfeeding patients.

Read more about the impact of cancer treatment on fertility opens in a new tab or window
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the anti-cancer regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences.Suggested dose modifications are based on clinical trial findings, product information, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) opens in a new tab or window unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.

Note:

  • Dose modifications in this section are as per Fenaux et al.r unless otherwise specified.
  • Initial treatment should not be started if ANC less than 0.5 x 109/L and/or platelets less than 50 x 109/L.
Dose reduction steps for lenalidomide to manage haematological toxicities
Starting dose 10 mg
Dose level 1 5 mg
Dose level 2 5 mg on alternate days
Dose level 3 5 mg twice a week
Dose level 4 Discontinue lenalidomide
Haematological toxicity
ANC x 109/L (pre-treatment blood test)
First fall to less than 0.5 Interrupt lenalidomide treatment
Return to greater than or equal to 0.5  Resume lenalidomide at dose level 1
For each subsequent drop less than 0.5 Interrupt lenalidomide treatment
Return to greater than or equal to 0.5 Resume at next lower dose level (dose level 2 to 4)
Do not dose below 5 mg
Consider using G-CSF opens in a new tab or window if neutropenia is the only toxicity at any dose level and maintaining the current lenalidomide dose
Platelets x 109/L (pre-treatment blood test)  

First fall to less than 25

 Interrupt lenalidomide treatment

Return to 25 or greater AND less than 50 on 2 or more occasions for 7 or more days
or
Return to 50 or greater at any time

 Resume lenalidomide at dose level 1

For each subsequent drop less than 25

 Interrupt lenalidomide treatment
Return to 25 or greater AND less than 50 on 2 or more occasions for 7 or more days
or
Return to 50 or greater at any time		 Resume lenalidomide at next lower dose level (dose level 2 - 4)
Do not dose below 5 mg
Kidney dosing recommendations 
  • Suggested dose modifications are based on the International Consensus Guideline on Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD).
  • Where one or more drugs in a protocol is recommended to be avoided, consider using a clinically appropriate alternative treatment protocol instead.
  • Before dose adjusting or omitting a drug, consider treatment intent.
  • In kidney replacement therapy consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing. 
  • For complete information on individual drug recommendations please review the individual drug monograph in the ADDIKD guideline.
  • Lenalidomide - after initial dose adjustment, there should be a continuous process of dose adjustment considering variations in kidney function during treatment and drug tolerance.
eGFR
(mL/min/1.73m2)		 Lenalidomide*
≥ 60

Full dose
45 - 59

Reduce to 5 mg daily

Increased risk of adverse events
30 - 44

Reduce to 5 mg daily

Increased risk of adverse events
15 - 29

Reduce to 5 mg every 48 hours

Increased risk of adverse events
< 15
(without kidney replacement therapy)

Reduce to 5 mg every 48 hours

Increased risk of adverse events
Kidney replacement therapy^

Reduce to 5 mg three times a week post dialysis^

Increased risk of adverse events

* The dose reduction applies to each individual dose and not to the total number of days or duration of lenalidomide per treatment cycle.

^ Dialysis dosing recommendation as per the lenalidomide product information and included as per the RCM.
Hepatic impairment
No formal studies of lenalidomide in patients with hepatic impairment, therefore no specific dose recommendations. If abnormal liver function tests are reported, interrupt lenalidomide treatment. Once parameters have returned to baseline, treatment at a lower dose may be considered.
Thromboembolismr
Interrupt lenalidomide and start anticoagulation therapy. Once stabilised on anticoagulation and any complications of thromboembolism have been managed, lenalidomide may be restarted at the original dose depending on the risk-benefit assessment and continue anticoagulation if restarting lenalidomide.
Dermatological reactionsrr
Rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. These may be potentially fatal.
Rash
Grade 1 Continue lenalidomide. Treat with topical corticosteroids and oral antihistamines.
Grade 2 Consider interruption of lenalidomide. Treat with topical corticosteroids and oral antihistamines until toxicity resolves.
Grade 3 Consider interruption of lenalidomide. Treat with oral antihistamines or oral corticosteroids until toxicity resolves.
Stevens-Johnson syndrome or Toxic epidermal necrolysis Permanent discontinuation of lenalidomide treatment. 

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources:  

For more information see References & Disclaimer.

Lenalidomide
  Interaction Clinical management
Digoxin Potentially increased digoxin plasma levels when combined with lenalidomide; mechanism unknown Monitor digoxin levels and for signs of drug toxicity during treatment with lenalidomide
Nephrotoxic drugs (e.g. aminoglycosides, amphotericin, contrast dye, frusemide, NSAIDs) Additive nephrotoxicity Avoid combination or monitor kidney function closely
HMG-CoA reductase inhibitors (Statins) Potentially additive toxicity Monitor for signs and symptoms of myotoxicity and rhabdomyolysis (e.g.: unexplained muscle pain, muscle stiffness or tenderness, dark urine) during concomitant use
Erythropoietic agents, combined oral contraceptives or hormone replacement therapy Additive risk of thromboembolic events due to an increased risk of VTE Consider the benefit/risk of concomitant therapy
Immunosuppressants (e.g. abatacept and baricitinib etc.) Increased risk of infection Concurrent use not recommended. If an immunosuppressant must be used, monitor closely for signs of infection
Bile acid sequestrants (e.g. colestyramine) Potentially reduced lenalidomide absorption when taken at the same time Administer lenalidomide 1 hour before or 4-6 hours after colestyramine
Vaccines
 Vaccines

Diminished response to vaccines and increased risk of infection with live vaccines.

Live vaccines (e.g. BCG, MMR, zoster and varicella) are contraindicated in patients on immunosuppressive therapy. Use with caution in patients on non-immunosuppressive therapy.

For more information; refer to the recommended schedule of vaccination for cancer patients, as outlined in the Australian Immunisation Handbook opens in a new tab or window

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter or address chemical compatibilities related to IV drug preparation and administration. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA opens in a new tab or window and Australian Injectable Drugs Handbook opens in a new tab or window websites for further information.

eviQ is currently updating the way information is presented in the administration section, if you notice any discrepancies please let us know, via feedback@eviq.org.au.

Day 1 - 21

This is an oral treatment

Pre treatment assessment

Any toxicity grade 2 or greater may require dose reduction, delay or omission of treatment and review by medical officer before commencing treatment.

Anti-cancer drug patient assessment tool prior to each day of treatment.

Lenalidomide

Administer lenalidomide:
  • orally ONCE a day, at the same time each day, on days 1 to 21 every 28 days
  • to be swallowed whole with a glass of water; do not break, crush or chew
  • can be taken either with or without food.

Note: missed doses should not be taken if it is less than 12 hours until the next dose.

Post administration

Continue safe handling precautions (reproductive risk only) for 7 days after completion of drug(s).

Discharge information

Discharge medications

Lenalidomide capsules - with written instructions on how to take them.

Growth factor support - as/if prescribed, and arrangements for administration.

Antiemetics - as/if prescribed.

Prophylaxis medications - as/if prescribed, i.e. antivirals, PJP prophylaxis, tumour lysis prophylaxis and medication for constipation.

Patient information

Ensure patient receives protocol patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Flu-like symptoms
Taste and smell alteration

Read more about taste and smell changes

Early (onset days to weeks)
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about immediate management of neutropenic fever
Thrombocytopenia

A reduction in the normal levels of functional platelets, increasing the risk of abnormal bleeding.  

Read more about thrombocytopenia
Abdominal pain

Dull ache, cramping or sharp pains are common with some anti-cancer drugs. These are caused by either increased or decreased gastrointestinal motility and can be associated with diarrhoea or constipation.
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Constipation
Cough
Diarrhoea

Read more about treatment induced diarrhoea
Fatigue

Read more about fatigue
Headache
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Respiratory tract infection
Skin rash

Anti-cancer drugs can cause a number of changes in the skin with maculo-papular rash the most common type of drug-induced skin reaction. 

Read more about skin rash
Thromboembolism

Arterial and venous thromboembolic events, including pulmonary embolism, deep vein thrombosis and cerebrovascular accidents can occur. Patients should be carefully assessed for risk factors, and consideration given for antithrombotic prophylaxis in high risk patients.

Late (onset weeks to months)
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia
Hypothyroidism
Muscle cramps

Cramping in the hands, calves and/or thighs associated with hypomagnesaemia (low magnesium) and/or hypocalcaemia (low calcium). 
Diarrhoea (late onset)

Chronic loose stools due to bile acid malabsorption has been observed in patients receiving lenalidomide. Referral to Gastroenterology should be considered. An empiric trial of cholestyramine (a bile-acid binding resin) is reasonable for these patients.

Read more about treatment induced diarrhoea
Stevens-Johnson syndrome (SJS)

Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) is characterised by fever, malaise, a painful rash, erythematous macules, targetoid lesions, or diffuse erythema progressing to vesicles and bullae, and oral, ocular and/or genital mucositis with painful mucosal erosion. Patients who develop SJS/TEN should never be re-exposed to the causative agent.

Delayed (onset months to years)
Cataract

A disorder characterised by partial or complete opacity of the crystalline lens of one or both eyes. This results in a decrease in visual acuity and eventual blindness if untreated. 
Secondary malignancies

A phase II multicentre international single-arm open-label trial (CC-5013-MDS-003)r investigated 148 patients with International Prognostic Scoring System (IPSS) Low- or Intermediate-1-risk myelodysplastic syndrome (MDS) with a deletion 5q abnormality, who received 10 mg of lenalidomide for 21 days every 4 weeks or daily. Increased red blood cell transfusion independence (RBC-TI) (irrespective of karyotype complexity) and cytogenetic responses were observed.

A subsequent phase III multicentre international randomised controlled trial (CC-5013-MDS-004)r compared the efficacy and safety of lenalidomide (either 10 mg for 21 days every 4 weeks or 5 mg daily) to placebo in 205 RBC transfusion-dependent IPSS Low- or Intermediate-1-risk MDS with deletion 5q. Patients were enroled from July 2005 to June 2007. Of note, exclusion criteria included absolute neutrophil count <500/µL, platelet count <25 000/µL, or proliferative chronic myelomonocytic leukaemia (CMML); additionally, concurrent use of erythropoiesis-stimulating agents was prohibited. In a modified intent-to-treat analysis, lenalidomide therapy was shown to result in increased RBC-TI, health-related quality of life (QOL), and cytogenetic response rates compared to placebo. The most common grade 3 or 4 adverse effect observed was myelosuppression.

A further randomised controlled trial (CC-5013-MDS-005)r demonstrated that increased RBC-TI and improved health-related QOL could be achieved with lenalidomide in IPSS Low- or Int-1-risk MDS patients without the deletion 5q cytogenetic abnormality, who were ineligible for or refractory to erythropoiesis-stimulating agents. There was also a trend towards improved cytogenetic responses in non-del(5q) MDS, though the study was likely underpowered to assess this.

Efficacy

In the CC-5013-MDS-004 randomised controlled trial,r the primary endpoint of RBC-TI for at least 26 weeks was achieved in 56.1% of patients receiving lenalidomide 10 mg, 42.6% of patients receiving lenalidomide 5 mg, and 5.9% of patients receiving placebo. Among those who achieved RBC-TI for at least 26 weeks, the onset of response was during cycle 1 or 2 for 86% of patients. Median duration of protocol-defined RBC-TI was not reached (median follow-up, 1.55 years). A subgroup analysis demonstrated improved RBC-TI in the 10 mg compared to the 5 mg receiving patients in most subgroups.

Table 1: Red blood cell transfusion independencer

© Blood 2011

In those who responded to lenalidomide, median maximum haemoglobin increases were 6.3 g/dL (range, 1.8-10.0 g/dL) with 10 mg and 5.2 g/dL (range, 1.5-8.5 g/dL) with 5 mg.

Figure 1: Haemoglobin change from baseliner

© Blood 2011

Cytogenetic response rates (complete and partial) were 50.0% and 25.0% in the lenalidomide 10 mg and 5 mg groups, respectively (P = 0.066). Complete cytogenetic response rates were 29.4% and 15.6%, respectively (P = 0.29). No cytogenetic responses occurred in the placebo group (P < 0.001 vs both lenalidomide groups). Statistically significant differences between groups were not observed for the incidence of cytogenetic progression.

Lenalidomide responders (defined as RBC-TI for ≥8 weeks in a landmark 6-month analysis) had longer acute myeloid leukaemia (AML)-free survival than non-responders (P = 0.048). On the other hand, statistical significance was not demonstrated for AML-free survival between randomisation groups or between cytogenetics responders and non-responders.

Figure 2: Time to AML progression by randomisation group (A), by cytogenetic response (B), and by RBC-TI for ≥8 weeks in patients randomised to lenalidomide (C)r

© Blood 2011

The median duration of overall survival (OS) follow-up was 35.9 months in the placebo group, 35.5 months in the lenalidomide 5 mg group, and 36.9 months in the lenalidomide 10 mg group. Median rates of OS were 42.4 months (95% CI, 31.9 to not reached), ≥ 35.5 months (95% CI, 24.6 to not reached), and 44.5 months (95% CI, 35.5 to not reached) in the placebo, lenalidomide 5 mg, and 10 mg groups, respectively.

Figure 3: Overall survival by randomisation group (A), by cytogenetic response (B), and by RBC-TI for ≥8 weeks in patients randomised to lenalidomide (C)r

© Blood 2011

Toxicity

The most common grade 3 or 4 adverse events (AEs) during the double-blind phase of the CC-5013-MDS-004 randomised controlled trialr were myelosuppression and deep vein thrombosis (DVT). Grade 3 or 4 neutropenia and thrombocytopenia generally occurred within the first 2 cycles and subsequently decreased. In 5 of 6 cases, DVT occurred within 3 months of treatment initiation (range, 1-12 months). Other grade 3 or 4 AEs included infection (10 mg: 16%; 5 mg: 9%) and febrile neutropenia (10 mg: 1%; 5 mg: 3%); no grade 3 or 4 bleeding was reported.

Table 2: Adverse events

© Blood 2011

Lenalidomide dose reductions were required because of AEs in 38 patients (55.1%) and 36 patients (52.2%) in the lenalidomide 10 mg and 5 mg groups, respectively. Dose interruption was reported in 32 patients (46.4%) and 20 patients (29.0%), respectively. The most common reasons for dose reduction or interruption were neutropenia and thrombocytopenia.

Discontinuation from double-blind treatment because of AEs was reported in 6 patients (8.7%) in the lenalidomide 10 mg group, 12 patients (17.4%) in the 5 mg group, and 3 patients (4.5%) in the placebo group. Discontinuations because of neutropenia were reported in 1 patient (1.4%) in each of the lenalidomide groups.

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Version 2

Date Summary of changes
26/10/2023

Protocol updated with ADDIKD guideline recommendations. New kidney dosing recommendation table added to dose modification section.

PDF of previous protocol.

Version number changed to V.2.
08/03/2024 Reviewed electronically by the eviQ Haematology Reference Committee. No changes. Review in 2 years.

Version 1

Date Summary of changes
24/02/2023 New eviQ protocol presented at 2023 Haematology Reference Committee Meeting. Approved for publication.
04/05/2023

Published on eviQ as v.1.

Review in 1 year.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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First approved:
Last reviewed:
Review due:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/4261

11 May 2025