Where smoldering myeloma treatment is heading
Smoldering myeloma · Updated Nov 14, 2026
Smoldering multiple myeloma is an early, symptom-free stage of myeloma: abnormal plasma cells are in the bone marrow but have not yet damaged bones, kidneys or blood counts. Several thousand people a year in the US are diagnosed, often by chance. For decades the standard was to watch and wait. Daratumumab became the first approved treatment for high-risk smoldering myeloma in 2025, and bispecific antibodies are now being tested to stop the disease before it becomes myeloma.
- 55studies open or running
- 5phase 3 trials
- 99papers published this year
- 1NIH-funded projects
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Now
Nov 2026
First approved treatmentHappened 63.1% progression-free at 5 yrs
Daratumumab: 63.1% progression-free at 5 years vs 40.8% with monitoring, and better survival. FDA approved November 2025.
63.1%: progression-free at 5 years, vs 40.8% with monitoring.
A bispecific antibody clears diseaseHappened 92% progression-free at 2 yrs
Teclistamab: 92% progression-free at 2 years vs 49% with lenalidomide-dexamethasone.
92%: progression-free at 2 years, vs 49% with lenalidomide-dexamethasone.
Early treatment helps across trialsHappened 0.40 hazard ratio
Pooled trials: 60% lower risk of progression or death with early treatment.
0.40: hazard ratio for progression or death with early treatment.
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6 months
by May 2027
Who counts as high riskLikely
Risk models and blood tests increasingly decide who should be treated rather than watched.
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12 months
by Nov 2027
More bispecific antibody dataPossible
Elranatamab (European Myeloma Network) and teclistamab-daratumumab trials report on high-risk smoldering myeloma; due 2027-2028.
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3 years
by late 2029
A three-drug approach in the USPossible
ECOG-ACRIN EAA173 (288 people) tests adding daratumumab to lenalidomide-dexamethasone; due December 2029.
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5 years
by late 2031
Isatuximab combinationLong shot
Sanofi's ITHACA (337 people) tests isatuximab plus lenalidomide-dexamethasone; due October 2030.
Bispecific vs daratumumabLong shot 92% progression-free (teclistamab)
Regeneron's LINKER-SMM2 (270 people) compares linvoseltamab directly with daratumumab; due 2033.
92%: progression-free at 2 years, vs 49% with lenalidomide-dexamethasone.
The research paths
Antibodies to delay progression
63.1% progression-free at 5 yrsDetails and 2 trialsHide
CD38 antibodies alone or with lenalidomide.
WatchEAA173; ITHACA.
Bispecific antibodies to eliminate disease
92% progression-free at 2 yrsDetails and 5 trialsHide
Time-limited T-cell engagers aiming for cure before myeloma develops.
WatchLINKER-SMM2; elranatamab.
- Linvoseltamab vs daratumumab (LINKER-SMM2)Regeneron · 270 people · enrolling Jul 2033
- Linvoseltamab to eliminate abnormal plasma cellsRegeneron · 116 people · enrolling May 2032
- Elranatamab for high-risk smoldering myelomaEuropean Myeloma Network · 50 people · fully enrolled Jul 2027
- Teclistamab vs lenalidomide-dexamethasone (Immuno-PRISM)Dana-Farber (Irene Ghobrial, MD) · 52 people · enrolling Jul 2030
- Teclistamab with daratumumabMemorial Sloan Kettering (C. Ola Landgren, MD) · 50 people · enrolling Dec 2028
Borrowed from other cancers
From Relapsed multiple myeloma
Teclistamab
Phase 2
A BCMA bispecific antibody first approved for heavily treated myeloma.
From Relapsed multiple myeloma
Linvoseltamab
Phase 3
A second BCMA bispecific now compared with daratumumab.
Open to join now
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High-risk smoldering myeloma
Lenalidomide-dexamethasone with or without daratumumab
Locations and eligibility → -
High-risk smoldering myeloma
Linvoseltamab vs daratumumab
Locations and eligibility → -
Smoldering myeloma
Linvoseltamab
Locations and eligibility → -
High-risk smoldering myeloma
Teclistamab
Locations and eligibility →
See every recruiting Smoldering myeloma trial →
When the trials finish
Completion dates the trials registered. Results usually follow 3 to 12 months later.
- Heating up
- Maturing
- Early
- Cooling
- Fully enrolled, waiting on results
- Still enrolling
What just happened
Teclistamab beats lenalidomide-dexamethasone
Immuno-PRISM, Nature Medicine.
FDA approves daratumumab for high-risk smoldering myeloma
AQUILA.
Standard treatment today
- Low riskMonitoring with blood tests every few months.
- Intermediate riskMonitoring, or a clinical trial.
- High riskDaratumumab for up to 3 years, or a clinical trial; lenalidomide is an alternative.
- Progression to active myelomaTreated as multiple myeloma.
How to read this page, and sourcesHow to read this page, and sources
- Most people with low-risk smoldering myeloma never need treatment; results here apply to high-risk disease.
- Forecasts are editorial judgments by Find a Trial, not predictions from sponsors or regulators.
See Smoldering myeloma trials recruiting now →