Smoldering plasma cell myeloma
diseaseOn this page
Also known as asymptomatic myelomaasymptomatic plasma cell myelomasmoldering multiple myelomasmoldering Multiple myeloma/plasma cell myelomasmoldering myelomasmouldering multiple myelomasmouldering Multiple myeloma/plasma cell myelomasmouldering myeloma
Summary
Smoldering plasma cell myeloma (MONDO:0005235) is a cancer and 82 clinical trials. Top therapeutic interventions include lenalidomide, daratumumab, and leflunomide. A subtype of plasma cell myeloma — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Classification: Cancer
- Clinical trials: 82
Clinical features
No curated clinical features (Orphanet) for this disease.
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | smoldering plasma cell myeloma |
| Mondo ID | MONDO:0005235 |
| EFO | EFO:0003073 |
| DOID | DOID:9551 |
| NCIT | C7149 |
| SNOMED CT | 440422002 |
| UMLS | C1531608 |
| MedGen | 280653 |
| GARD | 0024168 |
| Is cancer (heuristic) | yes |
Also known as: asymptomatic myeloma · asymptomatic plasma cell myeloma · smoldering multiple myeloma · smoldering Multiple myeloma/plasma cell myeloma · smoldering myeloma · smoldering plasma cell myeloma · smouldering multiple myeloma · smouldering Multiple myeloma/plasma cell myeloma · smouldering myeloma
Disease family
This is a subtype of plasma cell myeloma. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by etiologic mechanism › cancer or benign tumor › neoplastic disease or syndrome › neoplasm › cancer › immune system cancer › plasma cell myeloma › smoldering plasma cell myeloma
Related subtypes (2): osteosclerotic plasma cell myeloma, non-secretory plasma cell myeloma
Subtypes (1): indolent plasma cell myeloma
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
Drugs indicated for this disease
0 approved, 5 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.
| Drug | Development status |
|---|---|
| Daratumumab | Phase 3 (in late-stage trials) |
| Dexamethasone | Phase 3 (in late-stage trials) |
| Hyaluronidase (Human Recombinant) | Phase 3 (in late-stage trials) |
| Lenalidomide | Phase 3 (in late-stage trials) |
| Melphalan | Phase 3 (in late-stage trials) |
Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Carfilzomib, Cholestyramine, Elotuzumab, Elranatamab, Isatuximab, Leflunomide, Pomalidomide.
Clinical trials & evidence
Clinical trials
Clinical trials: 82.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| PHASE2 | 34 |
| Not specified | 32 |
| PHASE1 | 5 |
| PHASE3 | 4 |
| EARLY_PHASE1 | 4 |
| PHASE1/PHASE2 | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00114101 | PHASE3 | ACTIVE_NOT_RECRUITING | Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant |
| NCT01169337 | PHASE3 | ACTIVE_NOT_RECRUITING | Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma |
| NCT03301220 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma |
| NCT03937635 | PHASE3 | RECRUITING | Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma |
| NCT02415413 | PHASE2 | ACTIVE_NOT_RECRUITING | Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma |
| NCT02960555 | PHASE2 | ACTIVE_NOT_RECRUITING | Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR) |
| NCT03236428 | PHASE2 | ACTIVE_NOT_RECRUITING | Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma |
| NCT03289299 | PHASE2 | ACTIVE_NOT_RECRUITING | Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant |
| NCT03673826 | PHASE2 | ACTIVE_NOT_RECRUITING | Carfilzomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in High- Risk SMM |
| NCT03815279 | PHASE2 | ENROLLING_BY_INVITATION | A Nationwide Phase 2 Trial of Patients With Smoldering and Active Multiple Myeloma (MM) |
| NCT04776395 | PHASE2 | RECRUITING | Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma |
| NCT04850846 | PHASE2 | ACTIVE_NOT_RECRUITING | Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma |
| NCT05014646 | PHASE2 | ACTIVE_NOT_RECRUITING | Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients |
| NCT05469893 | PHASE2 | RECRUITING | Immuno-PRISM (PRecision Intervention Smoldering Myeloma) |
| NCT05597345 | PHASE2 | RECRUITING | Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma |
| NCT05767359 | PHASE2 | ACTIVE_NOT_RECRUITING | CAR- PRISM (PRecision Intervention Smoldering Myeloma) |
| NCT05841550 | PHASE1/PHASE2 | RECRUITING | The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma |
| NCT05955508 | PHASE2 | ACTIVE_NOT_RECRUITING | A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma |
| NCT06140524 | PHASE2 | RECRUITING | A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma |
| NCT06183489 | PHASE2 | RECRUITING | Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma |
| NCT06762769 | PHASE2 | RECRUITING | Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma |
| NCT00099047 | PHASE2 | COMPLETED | Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma |
| NCT00112827 | PHASE1/PHASE2 | COMPLETED | Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma |
| NCT00503763 | PHASE2 | WITHDRAWN | Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma |
| NCT00899353 | PHASE2 | TERMINATED | Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM) |
| NCT01222286 | PHASE2 | COMPLETED | Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma |
| NCT01237054 | PHASE2 | COMPLETED | Imaging in MGUS, SMM and MM |
| NCT01248455 | PHASE2 | TERMINATED | A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma |
| NCT01302886 | PHASE2 | COMPLETED | Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma |
| NCT01441973 | PHASE2 | COMPLETED | Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma |
| NCT01571726 | PHASE2 | WITHDRAWN | Imaging Studies and the Development of Multiple Myeloma |
| NCT01838369 | PHASE2 | TERMINATED | A Phase II Study of BI-505 in Smoldering Multiple Myeloma |
| NCT02279394 | PHASE2 | COMPLETED | E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma |
| NCT02353572 | PHASE1/PHASE2 | TERMINATED | Melphalan and Bortezomib Prior to Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma |
| NCT02903381 | PHASE2 | COMPLETED | A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma |
| NCT02916771 | PHASE2 | COMPLETED | Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma |
| NCT03839459 | PHASE2 | COMPLETED | Denosumab for Smoldering Multiple Myeloma |
| NCT03850522 | PHASE2 | TERMINATED | PD-L1 Peptide Vaccination in High Risk Smoldering Multiple Myeloma |
| NCT03952832 | PHASE2 | WITHDRAWN | Leflunomide in Treating Patients With High-Risk Smoldering Multiple Myeloma |
| NCT04731844 | PHASE2 | COMPLETED | Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| LENALIDOMIDE | 4 | 16 |
| DARATUMUMAB | 4 | 3 |
| LEFLUNOMIDE | 4 | 3 |
| ELOTUZUMAB | 4 | 2 |
| ISATUXIMAB | 4 | 2 |
| CARFILZOMIB | 4 | 1 |
| CHOLESTYRAMINE | 4 | 1 |
| CILTACABTAGENE AUTOLEUCEL | 4 | 1 |
| ELRANATAMAB | 4 | 1 |
| FLUDEOXYGLUCOSE F 18 | 4 | 1 |
| HYALURONIDASE (HUMAN RECOMBINANT) | 4 | 1 |
| MELPHALAN | 4 | 1 |
| SELINEXOR | 4 | 1 |
| TECLISTAMAB | 4 | 1 |
| IBERDOMIDE | 3 | 3 |
| LINVOSELTAMAB | 3 | 2 |
| CURCUMIN | 3 | 1 |
| IXAZOMIB | 3 | 1 |
| APRICOXIB | 2 | 1 |
| BHQ-880 | 2 | 1 |
| BI-505 | 2 | 1 |
| CITARINOSTAT | 2 | 1 |
| FLUCICLATIDE | 2 | 1 |
| HILTONOL | 2 | 1 |
| IPH-2101 | 2 | 1 |
| PROGRAMMED CELL DEATH 1 LIGAND 1 | 2 | 1 |
| METFORMIN XR | 0 | 2 |
| CHEMBL5204484 | 0 | 1 |
| CHEMBL2369717 | 0 | 1 |