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NCT03631043
Personalized Vaccine in Treating Patients With Smoldering Multiple Myeloma
EARLY_PHASE1 trial testing Biopsy Specimen Radiography in Smoldering Plasma Cell Myeloma in 30 participants. Completed in 10 December 2025.
10 December 2025
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 21 December 2018 |
| Primary completion | 10 December 2025 |
| Estimated completion | 10 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biopsy Specimen Radiography
- Lenalidomide — full drug profile →
- Vaccine Therapy — full drug profile →
Conditions studied
- Smoldering Plasma Cell Myeloma — all drugs for Smoldering Plasma Cell Myeloma →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Smoldering Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This early phase I trial studies the side effects of personalized vaccine in treating patients with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoantigens: promising targets for cancer therapy.
Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x -
Neoantigen prediction and computational perspectives towards clinical benefit: recommendations from the ESMO Precision Medicine Working Group.
De Mattos-Arruda L, Vazquez M, Finotello F, Lepore R, et al · · 2020 · cited 126× · PMID 32610166 · DOI 10.1016/j.annonc.2020.05.008 -
Selecting Target Antigens for Cancer Vaccine Development.
Buonaguro L, Tagliamonte M. · · 2020 · cited 97× · PMID 33080888 · DOI 10.3390/vaccines8040615 -
Personalized neoantigen vaccination with synthetic long peptides: recent advances and future perspectives.
Chen X, Yang J, Wang L, Liu B. · · 2020 · cited 69× · PMID 32483434 · DOI 10.7150/thno.38742 -
Neoantigen cancer vaccines: a new star on the horizon.
Li X, You J, Hong L, Liu W, et al · · 2023 · cited 31× · PMID 38164734 · DOI 10.20892/j.issn.2095-3941.2023.0395 -
A pilot study of pembrolizumab in smoldering myeloma: report of the clinical, immune, and genomic analysis.
Manasanch EE, Han G, Mathur R, Qing Y, et al · · 2019 · cited 31× · PMID 31405950 · DOI 10.1182/bloodadvances.2019000300 -
Neoantigens in Hematologic Malignancies.
Biernacki MA, Bleakley M. · · 2020 · cited 30× · PMID 32117272 · DOI 10.3389/fimmu.2020.00121 -
Advances and clinical applications of immune checkpoint inhibitors in hematological malignancies.
Sun W, Hu S, Wang X. · · 2024 · cited 19× · PMID 39073258 · DOI 10.1002/cac2.12587
Verify or expand the search:
- PubMed search for NCT03631043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Smoldering Plasma Cell Myeloma
Currently open trials in the same condition.
- NCT05312255 — Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple · NA · recruiting
- NCT05014646 — Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patient · Phase 2 · active not recruiting
- NCT04776395 — Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multipl · Phase 2 · recruiting
- NCT04370483 — Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma · EARLY_PHASE1 · active not recruiting
- NCT03937635 — Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma · Phase 3 · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03631043 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 19 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03631043.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing