NCT03591614

Dendritic Cell DKK1 Vaccine for Monoclonal Gammopathy and Stable or Smoldering Myeloma

Withdrawn EARLY_PHASE1 Last updated 18 August 2023

What this trial tests

EARLY_PHASE1 trial testing DKK1 in Monoclonal Gammopathy. Withdrawn.

Timeline

1 December 2023

Primary endpoint
1 August 2024

1 August 2025

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 December 2023
Primary completion	1 August 2024
Estimated completion	1 August 2025
Sites	2 locations across United States

Drugs / interventions tested

• DKK1 — full drug profile →

Conditions studied

• Monoclonal Gammopathy — all drugs for Monoclonal Gammopathy →
• Smoldering Myeloma — all drugs for Smoldering Myeloma →
• Myeloma — all drugs for Myeloma →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Monoclonal Gammopathy or Smoldering Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to study the safety and preliminary efficacy of a dendritic cell DKK1 vaccine against myeloma. Dendritic cells are immune cells that are collected from the blood of the patient at Case Western Reserve Medical Center and then brought into contact with DKK1, a molecule that is present of myeloma cells but not to a significant amount on other cells except for the prostate and the placenta. It is an investigational (experimental) vaccine that based on studies in the laboratory and in mice is expected to work by presentation of DKK1 to anticancer immune cells via dendritic cells leading to an immune attack on myeloma cells. It is experimental because it is not approved by the Food and Drug Administration (FDA).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: dendritic cell vaccination for cancer immunotherapy.
   Sprooten J, Ceusters J, Coosemans A, Agostinis P, et al · · 2019 · cited 107× · PMID 31646087 · DOI 10.1080/2162402x.2019.1638212
2. Multiple Myeloma Therapy: Emerging Trends and Challenges.
   Dima D, Jiang D, Singh DJ, Hasipek M, et al · · 2022 · cited 51× · PMID 36077618 · DOI 10.3390/cancers14174082
3. Dendritic Cell-Based Immunotherapy in Multiple Myeloma: Challenges, Opportunities, and Future Directions.
   Verheye E, Bravo Melgar J, Deschoemaeker S, Raes G, et al · · 2022 · cited 38× · PMID 35055096 · DOI 10.3390/ijms23020904
4. WNT Signaling in Hematological Malignancies.
   Frenquelli M, Tonon G. · · 2020 · cited 34× · PMID 33409156 · DOI 10.3389/fonc.2020.615190
5. Dickkopf Proteins and Their Role in Cancer: A Family of Wnt Antagonists with a Dual Role.
   Giralt I, Gallo-Oller G, Navarro N, Zarzosa P, et al · · 2021 · cited 15× · PMID 34451907 · DOI 10.3390/ph14080810
6. Early or deferred treatment of smoldering multiple myeloma: a meta-analysis on randomized controlled studies.
   Zhao AL, Shen KN, Wang JN, Huo LQ, et al · · 2019 · cited 13× · PMID 31296995 · DOI 10.2147/cmar.s205623
7. Boosting Immunity against Multiple Myeloma.
   Lopes R, Ferreira BV, Caetano J, Caetano J, et al · · 2021 · cited 6× · PMID 33799565 · DOI 10.3390/cancers13061221
8. Application of dendritic cell extracellular vesicles as a valid nanoparticle platform for cancer therapies: a narrative review.
   Nezamdoust FV, Nezhad-Mokhtari P, Mirzaahmadi B, Mazloumi Z, et al · · 2026 · PMID 42010708 · DOI 10.1186/s13287-026-05011-7