Discontinuation Outcome in Multiple Myeloma after BCMA-CD3 treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 May 2026 → ongoing

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 4

1. Identification of clinical and biological factors affecting the persistence of remission after stopping BCMA-CD3 bispecific antibody therapy (e.g. disease characteristics, number of earlier therapies, refractoriness, risk score, duration of treatment before stop, type of BCMA-CD3 pretreatment)
2. Estimation of overall, progression free survival, probabilities of an early restart of BCMA-CD3 bispecific antibody therapy without prior relapse according to current IMWG disease progression criteria and progression free survival 2 in the retreated group.
3. Patient reported QoL and symptom burden over time, including incidence of infections before and after treatment discontinuation and after treatment re-initiation.
4. Evaluation of medico-economic impact of stopping BCMA-CD3 bispecific antibody therapy and the number of patients who would be eligible for stopping BCMA-CD3 bispecific antibody therapy in Sweden.

Conditions and MedDRA coding

Multiple myeloma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. The subject has given their written consent to participate in the trial.
2. Multiple myeloma diagnosis according to IMWG criteria
3. On-going BCMA-CD3 bispecific antibody therapy
4. 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.
5. Measurable disease before BCMA-CD3 bispecific antibody treatment initiation by local analysis (defined as M-spike >5g/L or involved FLC >100mg/L)
6. Available baseline data from MM diagnosis
7. Available data on earlier MM treatments
8. 18 years or older

Exclusion criteria 4

1. Subjects who are unable to adhere to the monitoring of the disease according to protocol
2. Severe concomitant disease with life expectancy of < 6 month
3. Subjects without ability to give informed consent
4. Multiple myeloma of IgD or IgE type

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is disease free survival (DFS) based on sustained MMR after 6 months and 3 years.

Secondary endpoints 8

1. Efficacy: Survival: Overall Survival (OS) and Progression-Free Survival (PFS).
2. 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.
3. Efficacy: Treatment Re-response: Proportion of patients achieving at new MMR upon re-initiation of therapy.
4. Safety: Incidence and severity of adverse events, with special focus on infection rates (events per patient-year) during treatment versus after treatment discontinuation.
5. Healthcare Utilization & Economics: Number of hospitalization days per patient-year before versus after treatment discontinuation.
6. Healthcare Utilization & Economics: A health economic analysis assessing cost-effectiveness and resource utilization associated with treatment discontinuation.
7. 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.
8. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vaenersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Markus Hansson, Hematologimottagningen Sahlgrenska

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Markus Hansson, Hematologimottagningen Sahlgrenska

Third parties 1

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications