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Not yet recruitingNCT07878208IMPACTUpdated Oct 16, 2026

Immunoprofiling of the Patient Tumor Microenvironment in BCMA Targeted Therapies

An observational study in Myeloma, sponsored by Odense University Hospital. Not yet recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Odense University Hospital · Observational

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

The main goal of the project is to characterize the bone marrow immunological milieu and investigate potential treatment defining events of the tumor microenvironment in relapsed and refractory multiple myeloma (RRMM) patients receiving BCMA-targeted therapies.

Read the detailed description

This is a non-interventional, multicenter study conducted in collaboration with the Nordic Myeloma Study Group (NMSG). The study comprises a translational element and a prospective observational cohort. The primary objective of the study is to characterize the bone marrow immunological milieu and genomic profile post BCMA-targeted therapy and before initiation of subsequent treatment.

02

Conditions studied

  • Myeloma

Keywords

  • Tumor Microenvironment in BCMA Targeted Therapies
03

In context

Neoplasms, Plasma Cell

2,314 studies on the registry are indexed under Neoplasms, Plasma Cell; 247 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 266 observational studies indexed under Neoplasms, Plasma Cell.

Browse Neoplasms, Plasma Cell studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 477 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

To characterize the bone marrow immunological milieu and genomic profile post BCMA-targeted therapy and before initiation of subsequent treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed informed consent form.
  • Participant age ≥ 18 years.
  • Prior diagnosis of multiple myeloma according to the IMWG-criteria.
  • Progressive disease as defined by IMWG during and after treatment with a BCMA-targeted therapy.

Exclusion criteria

Exclusion Criteria:

- Initiated subsequent anti-myeloma treatment before inclusion.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. T-cell compartment fitness at the time of disease progression

    Time frame: At the time of relapse: Bone marrow sampling will be performed within 4 weeks of relapse, as defined according to IMWG criteria, and prior to initiation of subsequent therapy.

  2. Genetic status of the BCMA locus at relapse following BCMA-targeted therapy

    Time frame: At the time of relapse: Bone marrow sampling will be performed within 4 weeks of relapse, as defined according to IMWG criteria, and prior to initiation of subsequent therapy.

07

Study locations

7 sites
  • Aarhus University Hospital
    Aarhus, Denmark
    • Maja Ølholm Vase, MD, PhD · Contact · majavase@rm.dk · +45 78 45 00 00
  • Copenhagen University Hospital
    Copenhagen, Denmark
  • Regional Hospital Gødstrup
    Gødstrup, Denmark
  • Odense University Hospital
    Odense, Denmark
  • Zealand University Hospital, Roskilde
    Roskilde, Denmark
  • Vejle Hospital
    Vejle, Denmark
  • Oslo University Hospital
    Oslo, Oslo 0450, Norway
    • Jakob NORDBERG NØRGAARD, MD, PhD · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.

Of 87 non-industry observational studies under Neoplasms, Plasma Cell, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 95. This study's planned 23 months is below that.

Counting every sponsor, half of 114 studies reached it within 48 months; a quarter within 27 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2026
First posted
Oct 16, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Sep 30, 2028
CompletionEst.
Sep 30, 2030
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07878208
Responsible party
Sponsor
First posted
Oct 16, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2030 (estimated)
Last update
Oct 16, 2026

Study contacts

Jakub Krejcik, MD, PhD
Contact
jakub.krejcik@rsyd.dk
+4540337294
JAKOB NORDBERG NØRGAARD, MD, PhD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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