Lenalidomide 10 mg for Inflammation

Phase-Based Estimates
1
Effectiveness
2
Safety
St. Joseph's Hospital and Medical Center, Phoenix, AZ
Inflammation+7 More
Lenalidomide 10 mg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Inflammation

Study Summary

This study is evaluating whether lenalidomide may help reduce inflammation in individuals with Alzheimer's disease.

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Eligible Conditions

  • Inflammation
  • Cognitive Decline
  • Senile Plaques
  • Encephalitis
  • Nerve Degeneration
  • Cognitive Dysfunction
  • Neurodegeneration
  • Plaque, Amyloid
  • Mild Cognitive Impairment (MCI)
  • Inflammation, Brain

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Lenalidomide 10 mg will improve 4 primary outcomes, 1 secondary outcome, and 3 other outcomes in patients with Inflammation. Measurement will happen over the course of 18 months.

18 months
Change in blood inflammatory markers
Change in brain amyloid loads
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Change in cognition as assessed by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) total score
Change in cognition as assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) total score
Change in cognition as assessed by the Mini Mental State Examination (MMSE) total score
Change in neurodegeneration
Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Lenalidomide 5 mg
Neutropenia
80%
Thrombocytopenia
55%
Diarrhoea
46%
Rash
26%
Constipation
26%
Fatigue
25%
Pruritus
23%
Nausea
23%
Oedema Peripheral
22%
Nasopharyngitis
22%
Headache
17%
Muscle Spasms
17%
Leukopenia
17%
Back Pain
17%
Cough
17%
Dyspnoea
17%
Upper Respiratory Tract Infection
16%
Pyrexia
16%
Dry Skin
14%
Anaemia
14%
Asthenia
14%
Respiratory Tract Infection
13%
Acute Myeloid Leukaemia
12%
Dizziness
12%
Decreased Appetite
12%
Paraesthesia
12%
Vomiting
12%
Vertigo
12%
Abdominal Pain Upper
12%
Bronchitis
10%
Alanine Aminotransferase Increased
10%
Oropharyngeal Pain
10%
Gastroenteritis
10%
Abdominal Pain
10%
Hypokalaemia
10%
Hypertension
10%
Arthralgia
9%
Haematoma
9%
Weight Decreased
9%
Urinary Tract Infection
9%
Oral Herpes
9%
Insomnia
9%
Pain in Extremity
7%
Pneumonia
7%
Influenza
7%
Influenza Like Illness
7%
Non-Cardiac Chest Pain
7%
Musculoskeletal Pain
7%
Dyspnoea Exertional
6%
Myalgia
6%
Iron Overload
6%
Gastroenteritis Viral
6%
Dyspepsia
6%
Dry Mouth
6%
Peripheral Sensory Neuropathy
6%
Rhinitis
6%
Hypoalbuminaemia
6%
Depression
6%
Pharyngitis
4%
Hypomagnesaemia
4%
Pulmonary Embolism
4%
Neck Pain
4%
Contusion
4%
Epistaxis
4%
Oedema
4%
Petechiae
4%
Anxiety
4%
Febrile Neutropenia
3%
Sciatica
3%
Hyperhidrosis
3%
Wound
3%
Lower Respiratory Tract Infection
3%
Fall
3%
Cardiac Failure
3%
Flatulence
3%
Cystitis
3%
Atrial Fibrillation
3%
Hyperglycaemia
1%
Myelodysplastic syndrome
1%
Musculoskeletal Chest Pain
1%
Venous Thrombosis
1%
Phlebitis
1%
Pancytopenia
1%
Pyoderma Gangrenosum
1%
Diabetes Mellitus Inadequate Control
1%
Chest Pain
1%
Urinary Incontinence
1%
Leukaemia
1%
Respiratory Failure
1%
Renal Failure
1%
Injury
1%
Pain
1%
Pneumonia Aspiration
1%
Staphylococcal Sepsis
1%
Generalised Oedema
1%
Hypoxia
1%
Lung Disorder
1%
Lung Cancer Metastatic
1%
Refractory Anaemia with an excess of blasts
1%
Anxiety Disorder
1%
Tooth Disorder
1%
Intussusception
1%
Transfusion Reaction
1%
Hypoglycaemia
1%
Cytogenetic Abnormality
1%
Sinusitis
1%
Cataract
1%
Dysuria
1%
Non-cardiac Chest Pain
1%
Erysipelas
1%
Infection
1%
Chronic Obstructive Pulmonary Disease
1%
Urosepsis
1%
Mood Altered
1%
Deep Vein Thrombosis
1%
Fibromyalgia
1%
International normalised Ratio Increased
1%
Urine Human Chorionic Gonadotropin Abnormal
1%
Balance Disorder
0%
Osteoarthritis
0%
Joint Sprain
0%
Neutropenic Sepsis
0%
Autoimmune Thrombocytopenia
0%
Pulmonary Haemorrhage
0%
Haemoptysis
0%
Atrial Flutter
0%
Spinal Fracture
0%
Femoral Neck Fracture
0%
Malnutrition
0%
Alopecia
0%
Pneumonia Legionella
0%
Stress Urinary Incontinence
0%
Histiocytosis Haematophagic
0%
Suicide Attempt
0%
Septic Shock
0%
Bladder Cancer
0%
Angina unstable
0%
Delirium
0%
Breast Cancer
0%
Colon Cancer
0%
Humerus Fracture
0%
Amaemia Haemolytic Autoimmune
0%
Mucosal Inflammation
0%
General Physical Health Deterioration
0%
Tachyarrhythmia
0%
Cardiac Arrest
0%
Gastrointestinal Haemorrhage
0%
Colitis
0%
Intestinal Obstruction
0%
Intestinal Perforation
0%
Meniscus Lesion
0%
Synovial Rupture
0%
Urethral caruncle
0%
Coma
0%
Arterial Occlusive Disease
0%
Bone Marrow Failure
0%
Coagulopathy
0%
Haemolysis
0%
Thrombophlebitis Superficial
0%
Splenomegaly
0%
Arthritis
0%
Gouty Arthritis
0%
Tachycardia
0%
Conjunctivitis
0%
Multi-Organ Failure
0%
Bronchopneumonia
0%
Arthritis Bacterial
0%
Anal Abscess
0%
Cellulitis
0%
Bacteraemia
0%
Febrile Infection
0%
Cotard's Syndrome
0%
Pleural Effusion
0%
Pyelonephritis
0%
Interstitial Lung Disease
0%
Acute Respiratory Distress Syndrome
0%
Pulmonary Fibrosis
0%
Acute Leukaemia
0%
Colorectal Cancer
0%
Confusional State
0%
Acute Myocardial Infarction
0%
Myocardial Infarction
0%
Sinus Bradycardia
0%
Hypotension
0%
Haemorrhoidal Haemorrhage
0%
Spinal Compression Fracture
0%
Food Poisoning
0%
Subdural Haematoma
0%
Cerebral Haemorrhage
0%
Cerebrovascular Accident
0%
Renal Colic
0%
Joint Range of Motion Decreased
0%
Orthostatic Hypotension
0%
Chondropathy
0%
Skin Ulcer
0%
Urticaria
0%
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00179621) in the Lenalidomide 5 mg ARM group. Side effects include: Neutropenia with 80%, Thrombocytopenia with 55%, Diarrhoea with 46%, Rash with 26%, Constipation with 26%.

Trial Design

2 Treatment Groups

Placebo
Lenalidomide
Placebo group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lenalidomide 10 Mg is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Lenalidomide
Drug
Lenalidomide 10 mg/day taken daily orally for 12 months of treatment followed by 6 months washout. The trial will last 18 month in duration.
Placebo
Drug
Placebo taken daily orally for 12 months of treatment followed by 6 months washout. The trial will last 18 month in duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 months for reporting.

Who is running the study

Principal Investigator
M. S.
Prof. Marwan Sabbagh, Professor of Neurology, Barrow Neurological Institute
St. Joseph's Hospital and Medical Center, Phoenix

Closest Location

St. Joseph's Hospital and Medical Center - Phoenix, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Females in this study must have surgery that makes them sterile or be postmenopausal. show original
The person must have been diagnosed with MCI based on the NIA-AA criteria, which means that they had a documented MMSE score between 22-28 at both the screening and baseline visits. show original
The patient's CT or MRI scan of the brain must be consistent with the diagnosis of dementia and show no evidence of significant focal lesions or pathology which could contribute to dementia show original
The person must be on a stable dose of a cholinesterase inhibitor and/or memantine for 90 days before the Baseline (Week 00) and be expected to remain on a stable dose for the remainder of the study period show original
You must have good vision and hearing in order to comply with the study procedures. show original
The text talks about whether or not male or female outpatients are more likely to experience anxiety or depression. show original
At least 50 years old, but no older than 89. show original
To be able to take oral medications, you must have a good sense of taste and smell show original
The Hachinski ischemic score must be less than or equal to 4. show original
The Geriatric Depression Scale must be ≤ 10. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can inflammation be cured?

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If inflammation could be completely eliminated, infection, [allergy](https://www.withpower.com/clinical-trials/allergy), and all the various disorders in the field of immunology, and others, which suffer from it, would suffer drastically. In addition, a cure would solve many health and social problems. Thus an effective inflammation cure is a strong imperative for many, though many others may not agree with the implication of the idea that “this is the ultimate goal of the health care system, an end to human suffering and inflammation”.

Unverified Answer

What is inflammation?

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Inflammation is an important and frequently overlooked health concern. Most inflammation is chronic and associated with diseases, disorders and diseases of the heart, vascular, endocrine, muscular, immune, nervous, gastrointestinal, and respiratory systems.

Unverified Answer

What are common treatments for inflammation?

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Allergy and auto-immune disorders are commonly treated via the use of corticosteroids and medications such as antifungals, antibiotics, and other immunommodulators. Auto-immune disorders can be treated via immunosuppressant drugs such as azathioprine or cyclosporine.

Unverified Answer

What are the signs of inflammation?

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Fever, low-grade malaise, weight loss and night sweats are symptoms of inflammation. Some signs of inflammation such as erythema are symptoms of an infection. \nThe main signs of an infection are the sudden onset of symptoms which may range from mild such as an increased temperature to severe and life-threatening such as pneumonia which is common in adults with diabetes. Fever is the most common presenting symptom of infections in persons with diabetes.\n\nSigns and symptoms of diabetes can be grouped into acute and chronic.\n\nDiabetic ketoacidosis is caused by insulin deficiency. It is usually caused by diabetes mellitus.

Unverified Answer

What causes inflammation?

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Inflammation can often be considered as the "symptom" of a more fundamental problem with the immune system, although genetic and hormonal changes are part of the pathogenesis of some kinds of inflammation. Some aspects of inflammation are related to immunity and inflammation can be modulated by immune manipulation, although the precise mechanisms by which this occurs is currently under investigation.

Unverified Answer

How many people get inflammation a year in the United States?

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Chronic inflammation is common in America. Its prevalence changes little with ethnicity. It accounts for an estimated 2.2% of all visits and is responsible for 8% of most visits for conditions other than injury and is responsible for approximately 9% of all visits to primary care. The treatment options for chronic inflammatory disease (e.g., cholesterol, cardiovascular disease, nonalcoholic steatohepatitis, and type 2 diabetes) are relatively minor in primary care.

Unverified Answer

Does lenalidomide 10 mg improve quality of life for those with inflammation?

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Recent findings demonstrates significantly higher improvements in QoL and BMD, and significantly greater overall improvements in the symptoms reported by the patients taking lenalidomide compared to the placebo patients. All patients' symptoms improved: osteoarthritis (69% vs. 9%, P<or =0.0001), malaise (53% vs. 6%, P<or =0.0001), and swelling (46% vs. 8%, P<or = 0.001).

Unverified Answer

Has lenalidomide 10 mg proven to be more effective than a placebo?

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As a treatment option for moderate-to-severe active myelodysplastic syndromes, lenalidomide 10 mg (one morning infusion) is just as effective as the lenalidomide/rifampin combination and has a more tolerable adverse-reaction profile.

Unverified Answer

Is lenalidomide 10 mg typically used in combination with any other treatments?

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Lenalidomide 10 mg was a beneficial and well-tolerated drug in more than 25% of our patients, although they were typically treated in combination with other drugs (including steroids, a PASTA strategy, and/or other cytoreductive agents). The combination of lenalidomide with corticosteroids appeared to confer additive activity and may be a viable regimen for refractory PRA.

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Does inflammation run in families?

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These family data lend strong support to a major genetic contribution to inflammatory reactions, suggesting that genetic variants influencing inflammation may be located within the inflammatory cascade. Further studies that integrate disparate biological approaches such as cytokines, chemokines, and toll-like receptors may lead to the identification of critical genes and pathways underlying susceptibility to systemic inflammatory responses and their resolution.

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Who should consider clinical trials for inflammation?

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Clinical trial research should take into account the possibility that inflammation is a useful concept that can help understand or diagnose disease. Clinical trials with inflammatory biomarkers should be made available to practicing clinicians for research purposes. The development of new biomarkers to guide patient therapy would benefit from a clearer understanding of the inflammatory markers used in clinical research. Moreover, clinical trial research on inflammation will help standardize therapies, treatments and trial outcomes that are tailored to the inflammatory profile (including genetic factors and biomarkers) of each patient.

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Have there been any new discoveries for treating inflammation?

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While there have been multiple trials studying the efficacy of novel biologic medicines, the majority have come from small, non-consecutive series of patients. Additional studies with larger numbers of patients are needed to determine the effects of these treatments.

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