ELRANATAMAB for Multiple myeloma

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Subjects who are unable to adhere to the monitoring of the disease according to protocol\n- Severe concomitant disease with life expectancy of < 6 month\n- Subjects without ability to give informed consent\n- Multiple myeloma of IgD or IgE type"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is disease free survival (DFS) based on sustained MMR after 6 months and 3 years.","definition_or_measurement_approach":"DFS defined based on sustained MMR (molecular minimal measurable residual) at 6 months and 3 years as measured by M-spike response and high-sensitivity MaldiTOF-based monitoring."}

Secondary endpoints

• {"endpoint_text":"- Efficacy: Survival: Overall Survival (OS) and Progression-Free Survival (PFS).","definition_or_measurement_approach":"Overall Survival (OS) and Progression-Free Survival (PFS) as standard survival endpoints; measurement based on clinical follow-up and IMWG criteria for progression."}
• {"endpoint_text":"- Efficacy: Relapse: a.\tIncidence of MMR loss at 6 months and 3 years. b.\tIncidence of clinical relapse (as per IMWG criteria) at 6 months and 3 years. c.\tMedian time to MMR loss and to clinical relapse.","definition_or_measurement_approach":"Incidence of molecular relapse (MMR loss) and clinical relapse according to IMWG criteria at 6 months and 3 years; median time to events calculated from treatment stop date."}
• {"endpoint_text":"- Efficacy: Treatment Re-response: Proportion of patients achieving at new MMR upon re-initiation of therapy.","definition_or_measurement_approach":"Proportion achieving a new MMR after treatment re-initiation, measured by M-spike and free light chains."}
• {"endpoint_text":"- Safety: Incidence and severity of adverse events, with special focus on infection rates (events per patient-year) during treatment versus after treatment discontinuation.","definition_or_measurement_approach":"Adverse events recorded and graded (severity); infection rates reported as events per patient-year comparing periods on treatment vs after discontinuation."}
• {"endpoint_text":"- Healthcare Utilization & Economics: Number of hospitalization days per patient-year before versus after treatment discontinuation.","definition_or_measurement_approach":"Number of hospitalization days per patient-year compared before and after treatment discontinuation using health care utilization data."}
• {"endpoint_text":"- Healthcare Utilization & Economics: A health economic analysis assessing cost-effectiveness and resource utilization associated with treatment discontinuation.","definition_or_measurement_approach":"Health economic analysis of cost-effectiveness and resource utilization related to stopping therapy; specific methods not detailed in provided text."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change from baseline in QoL and symptom burden using EQ-5D instruments at serial time points."}
• {"endpoint_text":"- 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.\tThe risk of disease relapse (molecular and clinical). b.\tThe durability of treatment-free remission.","definition_or_measurement_approach":"Exploratory analyses of baseline clinical and biological factors associated with relapse risk and durability of treatment-free remission; biomarker measurement methods not specified in provided text."}

Sweden

Earliest CTIS Part Ii Submission Date

26-01-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

21

Number Of Sites

14

Number Of Participants

200

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"Sweden","full_name":"Region Skane Skanes Universitetssjukhus","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}