2025-524022-18-00RecruitingPhase 2
Discontinuation Outcome in Multiple Myeloma after BCMA-CD3 treatment
A multicenter prospective trial estimating the persistence of remission after stopping BCMA-CD3 bispecific antibody in multiple myeloma patients with major M-spike response by use MaldiTOF-based high sensitivity monitoring
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Feb 2026
Brief summary (registry, in English)
The primary objective of this trial is to assess the duration of remission and therapy free time after stopping BCMA-CD3 bispecific antibody therapy in patients with major M-spike response.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 28 Nov 2025
- Start date
- 22 May 2026
- Lead sponsor
- Vaestra Goetalandsregionen
- Diseases
- Multiple myeloma
- EU CT number
- 2025-524022-18-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma who are on BCMA-CD3 bispecific antibody treatment and have a complete response, to see how long remission lasts after stopping it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Multiple myeloma diagnosed by IMWG criteria. Biochemical complete response on treatment, with no measurable M-spike and normal or unmeasurable free light chains. Disease was measurable before treatment started (M-spike >5g/L or involved FLC >100mg/L).
- Earlier treatment
- Must be on ongoing BCMA-CD3 bispecific antibody therapy. Data on earlier myeloma treatments and baseline data from diagnosis must be available.
Main reasons for not taking part
- Cannot follow the disease monitoring set out in the protocol
- Severe other disease with life expectancy under 6 months
- Cannot give informed consent
- Multiple myeloma of IgD or IgE type
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concomitant disease with life expectancy of < 6 month
Other illness
- Subjects who are unable to adhere to the monitoring of the disease according to protocol
Other
- Subjects without ability to give informed consent
- Multiple myeloma of IgD or IgE type
Who the study is looking for
- The subject has given their written consent to participate in the trial.
- Multiple myeloma diagnosis according to IMWG criteria
- On-going BCMA-CD3 bispecific antibody therapy
- Biochemical complete response (CR), with unmeasurable M-spike and normal or unmeasurable free light chains on local analysis on ongoing BCMA-CD3 bispecific antibody therapy.
- Measurable disease before BCMA-CD3 bispecific antibody treatment initiation by local analysis (defined as M-spike >5g/L or involved FLC >100mg/L)
- Available baseline data from MM diagnosis
- Available data on earlier MM treatments
- 18 years or older
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soedra Aelvsborg Hospital Vaestra Goetalandsregionen | Boras | Sweden | Recruiting |
| Region Dalarna | Falun | Sweden | Recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen | Goteborg | Sweden | Recruiting |
| Region Halland | Halmstad | Sweden | Recruiting |
| Region Skane Helsingborg Hospital | Helsingborg | Sweden | Recruiting |
| Karolinska University Hospital | Huddinge | Sweden | Recruiting |
| Region Joenkoepings Laen | Jonkoping | Sweden | Recruiting |
| Region Oestergoetland | Linkoping | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus | Lund | Sweden | Recruiting |
| Region Oerebro Laen | Orebro | Sweden | Recruiting |
| NU Hospital Group-Vaestra Goetalandsregionen | Trollhattan | Sweden | Recruiting |
| Region Vaesterbotten | Umea | Sweden | Recruiting |
| Uppsala University Hospital | Uppsala | Sweden | Recruiting |
| Region Halland | Varberg | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.