2025-524022-18-00RecruitingPhase 2
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
Vaestra Goetalandsregionen13 sites in 1 country200 target enrollmentStarted: February 16, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 13
- Primary Endpoint
- The primary endpoint is disease free survival (DFS) based on sustained MMR after 6 months and 3 years.
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Subjects who are unable to adhere to the monitoring of the disease according to protocol
- •Severe concomitant disease with life expectancy of < 6 month
- •Subjects without ability to give informed consent
- •Multiple myeloma of IgD or IgE type
Outcomes
Primary Outcomes
The primary endpoint is disease free survival (DFS) based on sustained MMR after 6 months and 3 years.
The primary endpoint is disease free survival (DFS) based on sustained MMR after 6 months and 3 years.
Secondary Outcomes
- Efficacy: Relapse: a. Incidence of MMR loss at 6 months and 3 years. b. Incidence of clinical relapse (as per IMWG criteria) at 6 months and 3 years. c. Median time to MMR loss and to clinical relapse.
- Efficacy: Treatment Re-response: Proportion of patients achieving at new MMR upon re-initiation of therapy.
- Safety: Incidence and severity of adverse events, with special focus on infection rates (events per patient-year) during treatment versus after treatment discontinuation.
- Healthcare Utilization & Economics: Number of hospitalization days per patient-year before versus after treatment discontinuation.
- Healthcare Utilization & Economics: A health economic analysis assessing cost-effectiveness and resource utilization associated with treatment discontinuation.
- Patient-Reported Outcomes: Change from baseline in patient-reported Quality of Life (QoL) and symptom burden, measured using EQ-5D, assessed at serial time points throughout the study.
- Exploratory & Biomarker Analyses: Analysis of baseline factors (e.g., age, disease stage, cytogenetic risk, time since diagnosis, depth of initial response, refractoriness to prior lines of therapy) associated with: a. The risk of disease relapse (molecular and clinical). b. The durability of treatment-free remission.
- Efficacy: Survival: Overall Survival (OS) and Progression-Free Survival (PFS).
Investigators
Markus Hansson, Hematologimottagningen Sahlgrenska
Scientific
Vaestra Goetalandsregionen
Study Sites (13)
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