Where AL amyloidosis treatment is heading

About 4,000 people in the US are diagnosed with AL (light chain) amyloidosis each year. A small group of abnormal plasma cells in the bone marrow makes misfolded proteins that build up in the heart, kidneys and other organs, often causing heart failure. Treatment borrowed from multiple myeloma targets those plasma cells; daratumumab-based treatment is now standard and extends survival. New myeloma drugs (bispecific antibodies, CAR T cells) are moving into amyloidosis, and drugs that clear existing amyloid are being tested.

• 89studies open or running
• 7phase 3 trials
• 450papers published this year
• 1NIH-funded projects

1. Now

   Nov 2026

   Daratumumab extends survivalHappened 59.5% complete response

   Adding daratumumab: complete blood response 59.5% vs 19.2%, and 38% lower risk of death after 5 years.

   59.5%: complete blood response, vs 19.2% with VCd alone.

   • ANDROMEDA final analysis

   Amyloid-clearing antibody helps one subtypeHappened 62% lower risk of death (kappa)

   Anselamimab missed its overall goal, but cut deaths by 62% in kappa-type disease.

   62%: lower risk of death in kappa-type disease.

   • CARES trials (anselamimab)

   Options after first treatmentHappened 77.1% response rate

   Isatuximab produced blood responses in 77.1% of people with relapsed disease.

   77.1%: blood (hematologic) response rate.

   • SWOG S1702 trial

2. 6 months

   by May 2027

   Anselamimab for kappa-type diseasePossible

   Regulators and the sponsor will decide whether the kappa-subgroup benefit supports approval or a new trial.

   • CARES trials (anselamimab)

   Bispecific antibodies at relapseLikely

   More data from linvoseltamab, teclistamab and elranatamab studies in relapsed AL amyloidosis.

   • Linvoseltamab phase 1/2 study
   • Linvoseltamab study

3. 12 months

   by Nov 2027

   CAR T cells for AL amyloidosisPossible

   Nexcella's NXC-201, with FDA Breakthrough Therapy designation, moves to a phase 3 against Dara-VCd (NEXICART-3).

   • NEXICART-3

4. 3 years

   by late 2029

   Is stem-cell transplant still needed?Possible 59.5% complete response (Dara-VCd)

   SWOG S2213 (338 people) tests whether transplant adds anything to Dara-VCd; due July 2030.

   59.5%: complete blood response, vs 19.2% with VCd alone.

   • ANDROMEDA final analysis
   • S2213

5. 5 years

   by late 2031

   Bispecific antibodies as first treatmentLong shot

   Regeneron's LINKER-AL1 (382 people) and AbbVie's etentamig trial (370 people) compare T-cell engagers with daratumumab-based treatment.

   • LINKER-AL1
   • Etentamig trial

The research paths

Borrowed from other cancers

Open to join now

• Newly diagnosed

  Dara-VCd with or without transplant

  Phase 3 · 117 sites

  Locations and eligibility →

• Relapsed

  Linvoseltamab

  Phase 1/2 · 21 sites

  Locations and eligibility →

• Relapsed

  Etentamig

  Phase 1/2 · 23 sites

  Locations and eligibility →

• AL amyloidosis

  Belantamab mafodotin combination

  Phase 1/2 · 16 sites

  Locations and eligibility →

• Relapsed

  AZD0120 CAR T cells

  Phase 1/2 · 18 sites

  Locations and eligibility →

See every recruiting AL amyloidosis trial →

When the trials finish

Completion dates the trials registered. Results usually follow 3 to 12 months later.

What just happened

Standard treatment today

• Newly diagnosedDaratumumab with bortezomib, cyclophosphamide and dexamethasone (Dara-VCd).
• Fit, limited heart involvementStem-cell transplant for some; its role is being retested.
• Advanced heart involvementDara-VCd at adjusted doses with careful heart monitoring and supportive care.
• RelapsedOther myeloma drugs: isatuximab, pomalidomide, venetoclax for t(11;14); bispecific antibodies and CAR T cells in trials.

See AL amyloidosis trials recruiting now →