Ambulatory Step-up Dosing of Elranatamab: An Observational Feasibility and Safety Evaluation of an Outpatient Approach Using Remote Monitoring and Emergency Therapy Plans

Ambulatory Step-up Dosing of Elranatamab: An Observational Feasibility and Safety Evaluation of an Outpatient Approach Using Remote Monitoring and Emergency Therapy Plans - SAFESTEP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039789

Enrollment

Registered

2026-04-10

Start date

2026-08-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C90.00

Interventions

Group 1: This is a non-interventional observational study. As part of the study, patients will complete quality-of-life questionnaires and, optionally, provide 1 stool sample and 1–3 blood samples. Da

incidence, severity, and management of CRS and other acute toxicities

timing of onset and duration of CRS episodes

frequency and type of emergency interventions used

use of medical resources

patient adherence and satisfaction

baseline risk factors as inflammatory markers, tumor burden

response rate)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Choice of outpatient Elranatamab step-up dosing program

Exclusion criteria

Exclusion criteria: concurrent participation in an interventional clinical trial

Design outcomes

Primary

Measure	Time frame
Proportion of patients who successfully complete the initial step-up dosing phase without requiring unplanned hospitalization for toxicity. The step-up phase is defined as the period from the first dose through ~48 hours after the first full dose (approximately Day 1 – Day 10 of therapy)	—

Secondary

Measure	Time frame
Incidence and Severity of CRS: The percentage of patients experiencing CRS of any grade during the step-up phase, and the distribution of CRS grades (using ASTCT consensus criteria). - Time to Onset and Duration of CRS - Frequency and type of emergency interventions used (e.g., at-home dexamethasone, tocilizumab, hospital admission) - Use of medical resources (unplanned emergency room visits, emergency calls, actual hospital admissions) - Patient adherence and satisfaction with outpatient monitoring (questionnaires, preference for outpatient vs. inpatient care, anxiety/stress levels) - Exploratory correlations between baseline risk factors (inflammatory markers, tumor burden, microbiome) and the occurrence/severity of CRS - Preliminary signs of efficacy (e.g., early response rate of multiple myeloma at the end of cycle 1)	—

Measure

Time frame

Incidence and Severity of CRS: The percentage of patients experiencing CRS of any grade during the step-up phase, and the distribution of CRS grades (using ASTCT consensus criteria). - Time to Onset and Duration of CRS - Frequency and type of emergency interventions used (e.g., at-home dexamethasone, tocilizumab, hospital admission) - Use of medical resources (unplanned emergency room visits, emergency calls, actual hospital admissions) - Patient adherence and satisfaction with outpatient monitoring (questionnaires, preference for outpatient vs. inpatient care, anxiety/stress levels) - Exploratory correlations between baseline risk factors (inflammatory markers, tumor burden, microbiome) and the occurrence/severity of CRS - Preliminary signs of efficacy (e.g., early response rate of multiple myeloma at the end of cycle 1)

—

Countries

Germany

Contacts

Public ContactChristoph Kimmich

Universitätsklinik für Innere Medizin - Onkologie und Hämatologie

Christoph.Kimmich@uni-oldenburg.de+49 441 4032614

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026