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Proteasome Inhibitor

pomalidomide for Light Chain Deposition Disease

Phase 1
Waitlist Available
Led By Jeffrey Zonder
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is studying the side-effects and best dose of two drugs, pomalidomide and bortezomib, when given together with dexamethasone, in treating patients with amyloid light-chain amyloidosis or light chain deposition disease.

Eligible Conditions
  • Light Chain Deposition Disease
  • Systemic Amyloidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose defined as the dose level before 2 of 6 patients experience dose-limiting toxicity (DLT) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Secondary outcome measures
Complete hematologic response rate (hCR)
Organ response rates (heart, liver, kidney)
Overall hematologic response rate (partial response [PR] + complete response [CR])
+2 more

Side effects data

From 2017 Phase 3 trial • 455 Patients • NCT01311687
51%
Anaemia
28%
Thrombocytopenia
27%
Fatigue
21%
Pyrexia
21%
Insomnia
20%
Neutropenia
17%
Asthenia
17%
Diarrhoea
15%
Back pain
15%
Constipation
14%
Dyspnoea
13%
Bone pain
12%
Muscular weakness
11%
Nausea
10%
Cough
10%
Oedema peripheral
9%
Pneumonia
9%
Epistaxis
9%
Dizziness
8%
General physical health deterioration
8%
Hypokalaemia
7%
Hypercalcaemia
7%
Hyperglycaemia
7%
Myopathy
7%
Muscle spasms
7%
Upper respiratory tract infection
7%
Decreased appetite
6%
Anxiety
6%
Pain in extremity
6%
Headache
6%
Hypocalcaemia
5%
Lymphopenia
5%
Acute kidney injury
5%
Arthralgia
5%
Dehydration
5%
Agitation
5%
Confusional state
5%
Leukopenia
5%
Bronchitis
5%
Oedema
4%
Vomiting
4%
Blood creatinine increased
4%
Septic shock
4%
Urinary tract infection
4%
Paraesthesia
3%
Cataract
3%
Myalgia
3%
Respiratory tract infection
3%
Chest pain
3%
Musculoskeletal pain
3%
Fall
3%
Swelling face
3%
Lethargy
3%
Palpitations
3%
Sinusitis
3%
Pruritus
3%
Lower respiratory tract infection
3%
Weight decreased
3%
Peripheral sensory neuropathy
3%
Hypotension
2%
Dry skin
2%
Sepsis
2%
Musculoskeletal chest pain
2%
Abdominal pain upper
2%
Dyspnoea exertional
1%
Encephalopathy
1%
Tumour pain
1%
Malaise
1%
Haemoptysis
1%
Lung infection
1%
Pseudomonal bacteraemia
1%
Radiculopathy
1%
Septic arthritis streptococcal
1%
Ophthalmic herpes zoster
1%
Hyperhidrosis
1%
Lung infiltration
1%
Chills
1%
Hyperviscosity syndrome
1%
Pseudomonal sepsis
1%
Renal impairment
1%
Herpes zoster
1%
Enteritis
1%
Pneumocystis jirovecii pneumonia
1%
Plasma cell myeloma
1%
Plasmacytoma
1%
Burning sensation
1%
Bacterial diarrhoea
1%
Pneumonia streptococcal
1%
Post herpetic neuralgia
1%
Delirium
1%
Circulatory collapse
1%
Skin abrasion
1%
Erythema
1%
Cellulitis
1%
Angina pectoris
1%
Cardiac arrest
1%
Bacteraemia
1%
Overdose
1%
Rib fracture
1%
C-reactive protein increased
1%
Cerebrovascular accident
1%
Contusion
1%
Blood thyroid stimulating hormone increased
1%
White blood cell count decreased
1%
Neuropathy peripheral
1%
Tremor
1%
Productive cough
1%
Rash
1%
Haematoma
1%
Gastrointestinal haemorrhage
1%
Hyperuricaemia
1%
Atrial fibrillation
1%
Cognitive disorder
1%
Aggression
1%
Influenza like illness
1%
Pathological fracture
1%
Adrenal insufficiency
1%
Nasopharyngitis
1%
Hot flush
1%
Sinus bradycardia
1%
Tachycardia
1%
Necrotising colitis
1%
Escherichia urinary tract infection
1%
Diabetic ketoacidosis
1%
Hemiparesis
1%
Renal failure
1%
Cardiac failure
1%
Diverticulitis
1%
Bacterial infection
1%
Infection
1%
Intervertebral discitis
1%
Femur fracture
1%
Humerus fracture
1%
Pneumonia pseudomonal
1%
Plasma cell leukaemia
1%
Dyspraxia
1%
Spinal cord compression
1%
Seizure
1%
Oropharyngeal pain
1%
Pulmonary oedema
1%
Lung disorder
1%
Mouth ulceration
1%
Tooth abscess
1%
Neutrophil count decreased
1%
Pancytopenia
1%
Atrial flutter
1%
Otorrhoea
1%
Device related infection
1%
Performance status decreased
1%
Device related sepsis
1%
Ophthalmic herpes simplex
100%
80%
60%
40%
20%
0%
Study treatment Arm
High-Dose Dexamethasone
Pomalidomide Plus Low-Dose Dexamethasone
HD-Dex / Pomalidomide

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pomalidomide, bortezomib, and dexamethasone)Experimental Treatment4 Interventions
Patients receive pomalidomide PO on days 1-21; bortezomib IV or SC on days 1, 8, and 15; and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bortezomib
2011
Completed Phase 3
~850
pomalidomide
2011
Completed Phase 3
~1060
dexamethasone
1995
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,747 Total Patients Enrolled
6 Trials studying Light Chain Deposition Disease
367 Patients Enrolled for Light Chain Deposition Disease
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,238 Total Patients Enrolled
1 Trials studying Light Chain Deposition Disease
35 Patients Enrolled for Light Chain Deposition Disease
Jeffrey ZonderPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

Frequently Asked Questions

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

Are there any Canadian healthcare facilities currently administering this clinical trial?

"As of now, 5 clinical centres are recruiting patients for this trial. These locales include Toronto, Durham and Denver as well as other neighbouring areas. It is advised that you pick the nearest test site to lessen your travel commitment if chosen to participate."

Answered by AI

What therapeutic benefits is pomalidomide typically utilized for?

"Pomalidomide is a medication commonly used to relieve the symptoms of ophthalmia, sympathetic. It has also been found to be effective in treating eye diseases like branch retinal vein occlusion and macular edema."

Answered by AI

What additional research has been completed related to the use of pomalidomide?

"The first study surrounding pomalidomide was initiated by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002. Since then, 1945 clinical trials have been concluded and 608 are still running as of today; the majority of these studies take place in Toronto, Ontario."

Answered by AI

What is the scope of subjects participating in this experiment?

"As of April 12th 2022, this study has ceased recruitment. When first posted on March 1st 2013, it was one of many clinical trials for multiple myeloma and pomalidomide. Currently 893 studies are actively admitting participants with multiple myeloma and 608 trials are recruiting patients to use pomalidomide."

Answered by AI

Has the Federal Drug Administration sanctioned pomalidomide for medical utilization?

"The safety of pomalidomide is rated a 1 since it has only been through the initial Phase 1 trial, indicating limited evidence for efficacy and security."

Answered by AI

Can individuals still participate in this particular experiment?

"The clinical trial registry, clinicaltrials.gov, indicates that this specific study has ceased recruitment as of April 12th 2022. Initially posted on March 1st 2013, the research is now closed to new participants; nevertheless, there are 1501 other medical studies currently open for enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDD
Jeffrey Zonder 2013. "First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01728259.
~1 spots leftby Apr 2025
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