Primary systemic amyloidosis

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ORPHA:314701OMIM:254500E85.0E85.1E85.2
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3Active trials21Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Primary systemic amyloidosis, also known as AL amyloidosis (immunoglobulin light chain amyloidosis), is a serious condition in which abnormal proteins called amyloid build up in organs and tissues throughout the body. These abnormal proteins are produced by plasma cells in the bone marrow — the same type of cells involved in a blood cancer called multiple myeloma. In AL amyloidosis, the plasma cells make misfolded pieces of antibodies (called light chains) that clump together and deposit in organs such as the heart, kidneys, liver, nerves, and digestive tract. Over time, these deposits damage the organs and prevent them from working properly. Symptoms depend on which organs are affected. Common problems include swelling in the legs and ankles, extreme tiredness, shortness of breath, numbness or tingling in the hands and feet, unexplained weight loss, and an enlarged tongue. Heart involvement (amyloid cardiomyopathy) is especially dangerous and can lead to heart failure. Kidney involvement often causes large amounts of protein to leak into the urine. Treatment focuses on stopping the production of the abnormal light chains. This is done using chemotherapy drugs similar to those used for multiple myeloma, sometimes combined with stem cell transplant. Newer therapies including daratumumab have significantly improved outcomes. Supportive care to manage organ damage is also very important. Early diagnosis and treatment are critical because organ damage can become irreversible if the disease progresses too far.

Also known as:

Key symptoms:

Extreme tiredness and fatigueSwelling in the legs, ankles, or feetShortness of breath, especially with activityNumbness or tingling in hands and feetUnexplained weight lossEnlarged tongue (macroglossia)Foamy or frothy urine from protein lossFeeling full quickly when eatingDizziness or lightheadedness when standing upEasy bruising, especially around the eyes (raccoon eyes)Irregular heartbeat or heart palpitationsDiarrhea or constipationDifficulty swallowingCarpal tunnel syndrome in both wristsSkin thickening or waxy appearance

Inheritance

Sporadic

Usually appears on its own, not inherited from a parent

Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

4 events
Mar 2026CAR-NK Therapy for Cardiac Amyloidosis

Second Affiliated Hospital, School of Medicine, Zhejiang University — PHASE1, PHASE2

TrialNOT YET RECRUITING
Oct 2024Rapid dFLC Response Predict CHR in AL Amyloidosis

Peking University People's Hospital — NA

TrialRECRUITING
Sep 2024The Impact of Systemic Light Chain Amyloidosis on Eyes

Zhongshan Ophthalmic Center, Sun Yat-sen University — NA

TrialRECRUITING
Apr 2016Molecular Imaging of Primary Amyloid Cardiomyopathy

Brigham and Women's Hospital — NA

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Primary systemic amyloidosis.

3 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

3 recruitingView all trials with filters →
N/A3 trials
Molecular Imaging of Primary Amyloid Cardiomyopathy
N/A
Actively Recruiting
PI: Sharmila Dorbala, MD (Brigham and Women's Hospital (AHA and NIH Studies)) · Sites: Boston, Massachusetts · Age: 1899 yrs
The Impact of Systemic Light Chain Amyloidosis on Eyes
N/A
Actively Recruiting
PI: chang he (Zhongshan Ophthalmic Center, Sun Yat-sen Universit) · Sites: Guangzhou, Guangdong · Age: 1880 yrs
Rapid dFLC Response Predict CHR in AL Amyloidosis
N/A
Actively Recruiting
PI: Yang Liu, M.D. · Sites: Beijing, Beijing Municipality; Beijing, Beijing Municipality +6 more · Age: 1899 yrs

Specialists

21 foundView all specialists →
CM
Craig C Hofmeister, MD, MPH
ATLANTA, GA
Specialist
PI on 1 active trial
CH
chang he
Guangzhou, Guangdong
Specialist

Rare Disease Specialist

78 Primary systemic amyloidosis publications
HM
Heather Landau, MD
NEW YORK, NY
Specialist
PI on 4 active trials
RM
Raymond Comenzo, MD
BOSTON, MA
Specialist
PI on 4 active trials
VM
Vaishali Sanchorawala, MD
BOSTON, MA
Specialist
PI on 11 active trials
VF
Vivek Roy, MD, FACP
JACKSONVILLE, FL
Specialist
PI on 2 active trials
CM
Craig B. Reeder, MD
PHOENIX, AZ
Specialist
PI on 1 active trial
MM
Mazen A Hanna, MD
CLEVELAND, OH
Specialist
PI on 3 active trials
SM
Shaji Kumar, M.D.
ROCHESTER, MN
Specialist
PI on 3 active trials
SM
Sharmila Dorbala, MD
BOSTON, MA
Specialist
PI on 3 active trials
RM
Rodney Falk, MD
BOSTON, MA
Specialist
PI on 2 active trials
AW
Ann Woolfrey
SEATTLE, WA
Specialist
PI on 5 active trials
YM
Yi-Bin A Chen, M.D.
BOSTON, MA
Specialist
PI on 1 active trial
YM
Yang Liu, M.D.
Beijing, Beijing Municipality
Specialist

Rare Disease Specialist

PI on 2 active trials
RP
Ronglih Liao, PhD
Specialist
PI on 1 active trial
RM
Riccardo Caccialanza, MD
Specialist
PI on 2 active trials
PM
Paul Armistead, MD
CHAPEL HILL, NC
Specialist
PI on 1 active trial
GP
Giampaolo Merlini, MD, PhD
Specialist
PI on 1 active trial

Treatment Centers

8 centers
⚗️ Trial Site

Peking University First Hospital

📍 Beijing, Beijing Municipality

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

Travel Grants

No travel grants are currently matched to Primary systemic amyloidosis.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Primary systemic amyloidosis

Disease timeline:

New trial: The Impact of Systemic Light Chain Amyloidosis on Eyes

Phase NA trial recruiting.

New trial: Rapid dFLC Response Predict CHR in AL Amyloidosis

Phase NA trial recruiting. Dara IV

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.Which of my organs are affected by amyloid, and how much damage has occurred so far?,What is my cardiac staging, and what does that mean for my outlook?,Am I a candidate for stem cell transplant, and what are the risks and benefits?,What treatment regimen do you recommend, and what side effects should I expect?,How will we monitor my response to treatment, and how often will I need testing?,Should I be seen at a specialized amyloidosis center for a second opinion?,Are there any clinical trials available that might be appropriate for me?

Common questions about Primary systemic amyloidosis

What is Primary systemic amyloidosis?

Primary systemic amyloidosis, also known as AL amyloidosis (immunoglobulin light chain amyloidosis), is a serious condition in which abnormal proteins called amyloid build up in organs and tissues throughout the body. These abnormal proteins are produced by plasma cells in the bone marrow — the same type of cells involved in a blood cancer called multiple myeloma. In AL amyloidosis, the plasma cells make misfolded pieces of antibodies (called light chains) that clump together and deposit in organs such as the heart, kidneys, liver, nerves, and digestive tract. Over time, these deposits damage

How is Primary systemic amyloidosis inherited?

Primary systemic amyloidosis follows a sporadic inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Primary systemic amyloidosis typically begin?

Typical onset of Primary systemic amyloidosis is adult. Age of onset can vary across affected individuals.

Are there clinical trials for Primary systemic amyloidosis?

Yes — 3 recruiting clinical trials are currently listed for Primary systemic amyloidosis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Primary systemic amyloidosis?

21 specialists and care centers treating Primary systemic amyloidosis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.