Side Effects of lenalidomide: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Lenalidomide is an immunomodulatory drug used to treat multiple myeloma. 10 , 18 Lenalidomide has been shown to inhibit the growth of multiple myeloma cells and induce apoptosis. 10 Lenalidomide has also been shown to be effective in combination with other drugs in the treatment of multiple myeloma. 18 Lenalidomide is an effective drug for the treatment of multiple myeloma, both as a single agent and in combination therapy. 10 , 18

Reasons for Side Effects

The side effects of lenalidomide are related to its mechanism of action. Lenalidomide binds to the cereblon E3 ubiquitin ligase complex, altering its substrate specificity and promoting the degradation of intracellular proteins. 18 This can affect normal cells as well, potentially leading to side effects.

Common Side Effects

Hematologic Side Effects

The most common side effect of lenalidomide is hematologic side effects. 24 Lenalidomide can cause myelosuppression, which can lead to a decrease in the number of white blood cells, red blood cells, and platelets. 23 Lenalidomide can also increase the risk of thrombosis. 1 Hematologic side effects of lenalidomide can be reduced by decreasing the dose. 24

Skin Side Effects

Lenalidomide can cause skin side effects. 19 Skin side effects of lenalidomide include rash, itching, and redness. 11 Skin side effects of lenalidomide can be reduced by using topical medications, such as steroid ointments. 19

Neurological Side Effects

Lenalidomide can cause neurological side effects. 5 Neurological side effects of lenalidomide include peripheral neuropathy, dizziness, and headache. 5 Neurological side effects of lenalidomide can be reduced by decreasing the dose. 5

Gastrointestinal Side Effects

Lenalidomide can cause gastrointestinal side effects. 6 Gastrointestinal side effects of lenalidomide include loss of appetite, nausea, vomiting, and diarrhea. 6 Gastrointestinal side effects of lenalidomide can be reduced by using medications such as antiemetics. 6

Respiratory Side Effects

Lenalidomide can cause respiratory side effects. 20 Respiratory side effects of lenalidomide include pneumonia, cough, and shortness of breath. 20 Respiratory side effects of lenalidomide need to be treated with medications such as antibiotics. 20

Hepatic Side Effects

Lenalidomide can cause hepatic side effects. 1 Hepatic side effects of lenalidomide include jaundice and abnormal liver function. 1 Hepatic side effects of lenalidomide can be reduced by decreasing the dose. 1

Side Effect Management

Hematologic Side Effects Management

The management of hematologic side effects of lenalidomide may include decreasing the dose or temporarily stopping the administration. 24 If leukopenia or thrombocytopenia is severe, blood transfusions or platelet transfusions may be necessary. 24 If the risk of thrombosis is high, anticoagulants should be administered. 1

Skin Side Effects Management

The management of skin side effects of lenalidomide may include using topical medications, such as steroid ointments. 19 In severe cases, it may be necessary to stop the administration of lenalidomide. 19

Neurological Side Effects Management

The management of neurological side effects of lenalidomide may include decreasing the dose or temporarily stopping the administration. 5 If peripheral neuropathy is severe, it may be necessary to administer neuropathic pain medication. 5

Gastrointestinal Side Effects Management

The management of gastrointestinal side effects of lenalidomide may include using medications such as antiemetics. 6 In severe cases, it may be necessary to stop the administration of lenalidomide. 6

Respiratory Side Effects Management

The management of respiratory side effects of lenalidomide may include treatment with medications such as antibiotics. 20 In severe cases, it may be necessary to stop the administration of lenalidomide. 20

Hepatic Side Effects Management

The management of hepatic side effects of lenalidomide may include decreasing the dose or temporarily stopping the administration. 1 In severe cases, it may be necessary to stop the administration of lenalidomide. 1

Comparison Between Studies

Similarities in Research

Many studies have shown that lenalidomide is effective in the treatment of multiple myeloma. 10 , 18 Also, many studies have shown that lenalidomide can cause a number of side effects, including hematologic side effects, skin side effects, neurological side effects, and gastrointestinal side effects. 10 , 18 , 5 , 6 , 19 , 11 , 20 , 1 , 24 , 23

Differences in Research

The frequency and severity of side effects of lenalidomide vary depending on the study. 10 , 18 , 5 , 6 , 19 , 11 , 20 , 1 , 24 , 23 Also, the incidence of side effects of lenalidomide can be affected by a variety of factors, such as the patient’s age, gender, disease status, and concomitant medications. 10 , 18 , 5 , 6 , 19 , 11 , 20 , 1 , 24 , 23

Cautions for Real-Life Application

Lenalidomide is an effective drug for the treatment of multiple myeloma, but it can cause a number of side effects. 10 , 18 If you are taking lenalidomide, you should follow your doctor’s instructions and be aware of the potential side effects. 10 , 18 If you are concerned about side effects of lenalidomide, talk to your doctor. 10 , 18

Current Research Limitations

There is still not enough research on the side effects of lenalidomide. 10 , 18 In particular, there is a lack of research on the long-term side effects of lenalidomide. 10 , 18

Future Research Directions

Further research is needed to investigate the side effects of lenalidomide in more detail. 10 , 18 In particular, research on the long-term side effects of lenalidomide is important. 10 , 18 Research is also needed on ways to reduce the side effects of lenalidomide. 10 , 18

Conclusion

Lenalidomide is an effective drug for the treatment of multiple myeloma. 10 , 18 However, lenalidomide can cause a number of side effects. 10 , 18 If you are taking lenalidomide, you should follow your doctor’s instructions and be aware of the potential side effects. 10 , 18 If you are concerned about side effects of lenalidomide, talk to your doctor. 10 , 18

Literature analysis of 24 papers
Positive Content
19
Neutral Content
0
Negative Content
5
Article Type
2
0
2
5
21
1.

Slow increase of bilirubin concentration during administration of lenalidomide, bortezomib and dexamethasone for multiple myeloma (unmasking previously undiagnosed Gilbert syndrome) and disappearance of necrobiotic xanthogranuloma after complete remission of multiple myeloma.

Author: AdamZ, ŘehákZ, AdamováZ, PourL, DvořákováK, PackováB, KoukalováR, KrejčíMartin, KrejčíMarta, ŠtorkM, SandeckáV, BoichukI, KrálZ

Immunomodulatory effect
Diarrhea
Hyperbilirubinemia
Venous thromboembolism

This case report describes a patient with hyperbilirubinemia while on lenalidomid treatment, which was ultimately attributed to unrecognized Gilbert syndrome.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Subcutaneous panniculitis-like T-cell lymphoma invading central nervous system in long-term clinical remission with lenalidomide: A case report.

Author: SunJing, MaXiao-Shan, QuLi-Mei, SongXue-Song

Long-term remission
CNS involvement
Poor prognosis

This is the first reported case of subcutaneous panniculitis-like T-cell lymphoma (SPTCL) invading the central nervous system (CNS) achieving long-term remission with lenalidomide maintenance therapy.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

3.

Thalidomide before and after autologous stem cell transplantation in recently diagnosed multiple myeloma (HOVON-50): long-term results from the phase 3, randomised controlled trial.

Author: van de DonkNiels Wcj, van der HoltBronno, MinnemaMonique C, VellengaEdo, CroockewitSandra, KerstenMarie José, von dem BornePeter A, YpmaPaula, SchaafsmaRon, de WeerdtOkke, KleinSaskia K, DelforgeMichel, LevinMark-David, BosGerard M, JieKon-Siong G, SinnigeHarm, CoenenJules Llm, de WaalEsther G, ZweegmanSonja, SonneveldPieter, LokhorstHenk M

Improved event-free survival
Multiple myeloma treatment

This follow-up analysis of the HOVON-50 phase 3 trial investigated the long-term effects of thalidomide in induction and maintenance therapy for patients with newly diagnosed multiple myeloma. The study found that thalidomide-containing regimens were associated with improved event-free survival compared to regimens containing classical cytotoxic drugs after a median follow-up of 52 months.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

5.

Efficacy and toxicity profile of carfilzomib based regimens for treatment of multiple myeloma: A systematic review.

Author: MushtaqAdeela, KapoorVikas, LatifAzka, IftikharAhmad, ZahidUmar, McBrideAli, AbrahamIvo, RiazIrbaz Bin, AnwerFaiz

CFZ efficacy
MM treatment
HTN

Standard treatment for newly diagnosed multiple myeloma often involves a combination of three drugs, including a proteasome inhibitor like bortezomib. While effective, bortezomib can cause nerve problems (peripheral neuropathy). Carfilzomib (CFZ), another proteasome inhibitor, is more selective and has fewer side effects, including a lower risk of nerve problems. Studies show that CFZ is as effective as bortezomib and has a better safety profile, suggesting that it could be used as a first-line treatment for all types of multiple myeloma. However, more research is needed to determine the best dose of CFZ.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

6.

Safety of ixazomib for the treatment of multiple myeloma.

Author: BonnetAntoine, MoreauPhilippe

MM treatment
Oral administration
Cutaneous events
Digestive events
Hematological events

Ixazomib is the first oral proteasome inhibitor (PI) approved for the treatment of multiple myeloma (MM). This study reviews the preclinical and clinical evidence for ixazomib, highlighting its safety profile, efficacy, and potential role in long-term treatment strategies.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

The E3 ligase HUWE1 inhibition as a therapeutic strategy to target MYC in multiple myeloma.

Author: CrawfordLisa J, CampbellDavid C, MorganJonathan J, LawsonMichelle A, DownJennifer M, ChauhanDharminder, McAveraRoisin M, MorrisTreen C, HamiltonClaudia, KrishnanAswini, RajalingamKrishnaraj, ChantryAndrew D, IrvineAlexandra E

Anti-MM activity
Favorable therapeutic index

Proteasome inhibitors are a class of drugs used to treat multiple myeloma (MM). This study investigated the role of the E3 ligase HUWE1 in MM. The study found that HUWE1 is upregulated in MM cells and that inhibiting it can inhibit MM cell growth.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database.

Author: MontastrucJean-Louis, LafaurieMargaux, de CanecaudeClaire, DurrieuGeneviève, SommetAgnès, MontastrucFrançois, BagheriHaleh

Death

Antineoplastic/immunomodulating drugs were the most frequently involved drug class in fatal ADRs, and the risk was higher in males, in the Americas, and in patients ≥65 years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma.

Author: RichardsonPaul G, JacobusSusanna J, WellerEdie A, HassounHani, LonialSagar, RajeNoopur S, MedvedovaEva, McCarthyPhilip L, LibbyEdward N, VoorheesPeter M, OrlowskiRobert Z, AndersonLarry D, ZonderJeffrey A, MilnerCarter P, GasparettoCristina, AghaMounzer E, KhanAbdullah M, HurdDavid D, GowinKrisstina, KambleRammurti T, JagannathSundar, NathwaniNitya, AlsinaMelissa, CornellR Frank, HashmiHamza, CampagnaroErica L, AndreescuAstrid C, GentileTeresa, LiedtkeMichaela, GodbyKelly N, CohenAdam D, OpenshawThomas H, PasquiniMarcelo C, GiraltSergio A, KaufmanJonathan L, YeeAndrew J, ScottEmma, TorkaPallawi, FoleyAmy, FulcinitiMariateresa, HebertKyle, SamurMehmet K, MasoneKelly, MaglioMichelle E, ZeytoonjianAndrea A, NadeemOmar, SchlossmanRobert L, LaubachJacob P, Paba-PradaClaudia, GhobrialIrene M, PerrotAurore, MoreauPhilippe, Avet-LoiseauHervé, AttalMichel, AndersonKenneth C, MunshiNikhil C,

Progression-free survival
Adverse events

Adding autologous stem-cell transplantation (ASCT) to triplet therapy (lenalidomide, bortezomib, and dexamethasone [RVD]) was associated with longer progression-free survival (PFS) than RVD alone in patients with newly diagnosed multiple myeloma. The median PFS was 67.5 months in the transplantation group and 46.2 months in the RVD-alone group. No overall survival benefit was observed.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

16.

The Ubiquitination-Dependent and -Independent Functions of Cereblon in Cancer and Neurological Diseases.

Author: ZhouLiang, XuGuoqiang

Cancer treatment
Neurological disease treatment

Cereblon (CRBN) is a protein that plays a role in the teratogenic effects of thalidomide and the anti-myeloma effects of immunomodulatory drugs (IMiDs). This review discusses the functions of CRBN, including its role in ubiquitination and proteasome-mediated degradation. The review also explores the potential future directions for CRBN ligand-based drug discovery in the treatment of cancer and neurological diseases.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Rapid Progress in the Use of Immunomodulatory Drugs and Cereblon E3 Ligase Modulators in the Treatment of Multiple Myeloma.

Author: CharlińskiGrzegorz, VesoleDavid H, JurczyszynArtur

MM survival improved
Progression-free survival extended
Lenalidomide side effects
Pomalidomide side effects
Thalidomide side effects

Immunomodulatory drugs (IMiDs) like thalidomide, lenalidomide, and pomalidomide have significantly improved outcomes for multiple myeloma (MM) patients. These drugs target the cereblon (CRBN) protein, altering the function of the CRBN E3 ubiquitin ligase complex, leading to the breakdown of Ikaros and Aiolos proteins. IMiDs have proven beneficial in extending progression-free and overall survival in patients with newly diagnosed, post-transplant, and relapsed/refractory MM. Thalidomide, due to side effects, is less frequently used. Lenalidomide, with a better safety profile, is employed at all stages of MM treatment, often in combination with proteasome inhibitors and monoclonal antibodies. Pomalidomide is reserved for relapsed/refractory MM, also with PIs and monoclonal antibodies. Current research is focused on the development of IMiD derivatives, known as CRBN E3 ligase modulators (CELMoDs). This review highlights the significant impact of IMiDs in MM treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Simple desensitization protocol for multiple myeloma patients with lenalidomide-induced skin rash: Case series.

Author: SugiTomiyuki, MitaMitsuo, YasuTakeo, OharaShin, UchidaTomoyuki, InoueMorihiro, HagiharaMasao

Re-administration of LEN
Skin rash

A simple and slow desensitization protocol was effective in re-administering lenalidomide to 5 patients with severe LEN-induced skin rash. This protocol is recommended for elderly patients with no housemate to help with medical management.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

20.

Evaluation of Lung Toxicity With Lenalidomide Using the Pharmacovigilance Database.

Author: SatoJunya, ErenTsuchiya, MurataSaeko, ShimizuTadashi, UchidaMayako

LND lung toxicity

This study utilizes the Japanese Adverse Drug Event Report (JADER) database to investigate the incidence and onset timing of lenalidomide (LND)-related lung toxicity, analyzing its occurrence and outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

21.

Methodology of clinical trials evaluating the incorporation of new drugs in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL): a critical review.

Author: IacoboniG, ZuccaE, GhielminiM, StathisA

Improved DLBCL treatment

This study discussed the current standard treatment for diffuse large B-cell lymphoma (DLBCL), combining rituximab with CHOP chemotherapy, and explored the potential for improving treatment outcomes through ongoing clinical trials.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

22.

No needles needed: All-oral therapy options for relapsed and refractory multiple myeloma.

Author: FranzJoseph, MyrusElizabeth, SanchezLarysa, RichterJoshua

Multiple myeloma treatment
Quality of life
Treatment side effects

Oral therapies are increasingly used for relapsed and refractory multiple myeloma. This review summarizes available and investigational oral therapies, including lenalidomide, pomalidomide, and ixazomib, for patients with different treatment histories and disease characteristics. The review also discusses challenges in oral therapy, such as renal insufficiency and cytopenias.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

23.

Fludarabine and rituximab with escalating doses of lenalidomide followed by lenalidomide/rituximab maintenance in previously untreated chronic lymphocytic leukaemia (CLL): the REVLIRIT CLL-5 AGMT phase I/II study.

Author: EgleAlexander, SteurerMichael, MelchardtThomas, WeissLukas, GassnerFranz Josef, ZaborskyNadja, GeisbergerRoland, CatakovicKemal, HartmannTanja Nicole, PleyerLisa, VoskovaDaniela, ThalerJosef, LangAlois, GirschikofskyMichael, PetzerAndreas, GreilRichard

CLL treatment
Chemoimmunotherapy
Neutropenia
Skin toxicity

Combining lenalidomide with fludarabine and rituximab (FR) is feasible and effective for treating chronic lymphocytic leukemia (CLL), but individual changes in the immune system may be associated with limiting side effects.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

24.

Efficacy and Tolerability of High- versus Low-dose Lenalidomide Maintenance Therapy of Multiple Myeloma after Autologous Blood Stem Cell Transplantation.

Author: FenkRoland, GiagounidisAristoteles, GoldschmidtHartmut, HeinschMichael, RummelMathias, KrogerNicolaus, BoquoiAmelie, LopezDavid, GerrlichCelina, BaierJulia, LiesenjohannSvenja, HauckKatarzyna, SavickaiteIngrida, MaiElias K, AulCarlo, StrapatsasJudith, DienstAriane, KondakciMustafa, HaasRainer, KobbeGuido

Myeloma treatment
Side effects

This study investigated the dose response of lenalidomide maintenance therapy for multiple myeloma. The study found that dose reductions due to side effects are common, and median lenalidomide maintenance doses achieved over time may remain lower.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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