Development of novel minimally-invasive methods to determine the risk of progression for patients with smoldering multiple myeloma via longitudinal characterization of tumor cells and immune cells

Development of novel minimally-invasive methods to determine the risk of progression for patients with smoldering multiple myeloma via longitudinal characterization of tumor cells and immune cells - iMMunocell (German part only)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038561

Enrollment

100

Registered

2026-01-28

Start date

2020-03-02

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoldering Multiple Myeloma C90.0

Interventions

Group 1: This is a one-armed non-interventional study. Patients diagnosed with SMM presenting themselves at the Heidelberg University Hospital will be informed by the visiting physician and informatio

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with diagnosed SMM, which have presented at the Heidelberg University Hospital

Exclusion criteria

Exclusion criteria: - patients younger than 18 years of age - patients not capable of giving consent - pregnant patients

Design outcomes

Primary

Measure	Time frame
1 . Isolation of tumor cells from peripheral blood (PB) and bone marrow (BM) samples. In single-cell analyses, changes in the epigenome will be detected via ATACseq (Assay for Transposase-Accessible Chromatin using sequencing) and changes in the transcriptome via scRNAseq (Single-ce/1 RNA sequencing). 2. Characterization of myeloid, B- and T-cells as well as natural killer cells in PB and BM via flowcytometry. The identified immunesignatures will be compared to those already determined for healthy patients and myeloma patients at the University Clinic of Navarra in Spain. 3. Detection and quantification of circulating tumor cells in PB via NGF (next generation flow). Determination of mutational burden of circulating free DNA in PB via DNA-sequencing. Isolation of exosomes from PB and sequencing of the enclosed RNA. 4. Analysis of the expression of CRBN-binding proteins IKZF1, IKZF3, KPNA2, and basigin via flowcytometry in different immune cell populations, including plasma-, T- and NK-cells.	—

Measure

Time frame

1 . Isolation of tumor cells from peripheral blood (PB) and bone marrow (BM) samples. In single-cell analyses, changes in the epigenome will be detected via ATACseq (Assay for Transposase-Accessible Chromatin using sequencing) and changes in the transcriptome via scRNAseq (Single-ce/1 RNA sequencing). 2. Characterization of myeloid, B- and T-cells as well as natural killer cells in PB and BM via flowcytometry. The identified immunesignatures will be compared to those already determined for healthy patients and myeloma patients at the University Clinic of Navarra in Spain. 3. Detection and quantification of circulating tumor cells in PB via NGF (next generation flow). Determination of mutational burden of circulating free DNA in PB via DNA-sequencing. Isolation of exosomes from PB and sequencing of the enclosed RNA. 4. Analysis of the expression of CRBN-binding proteins IKZF1, IKZF3, KPNA2, and basigin via flowcytometry in different immune cell populations, including plasma-, T- and NK-cells.

—

Countries

Germany

Contacts

Public ContactElias Mai

Universitätsklinikum Heidelberg

elias.mai@med.uni-heidelberg.de+49 6221 56 8002

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026