RE-RITE: Real-world Evaluation of Response, Implementation and Toxicity of Elranatamab

NCT07891871 | Not Yet Recruiting

• 1 other identifier: 2026HAE153
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Elranatamab is an effective BCMA-targeting bispecific antibody for relapsed/refractory multiple myeloma (RRMM). However, implementation in routine practice remains challenging due to monitoring requirements during step-up dosing for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), together with the long-term burden of infection prevention and immunoglobulin replacement. Delivery models across the NHS vary considerably, including inpatient, ambulatory, outpatient, and virtual ward step-up dosing approaches. Supportive-care practice also evolved following NHS commissioning of primary immunoglobulin replacement for selected patients with hypogammaglobulinaemia. This study will evaluate real-world implementation of elranatamab across the NHS to identify approaches to safe, scalable, and equitable delivery. Primary objectives are to evaluate acute delivery pathways for CRS/ICANS management during step-up dosing and long-term infection management, including immunoglobulin replacement. Secondary objectives include assessment of healthcare resource utilisation, treatment delivery patterns, infection outcomes, and clinical outcomes across diverse healthcare and socioeconomic settings. The study population will be RRMM patients receiving elranatamab through NHS funding or compassionate access programmes from 01/01/2024 till 31/12/2026. Patients treated within clinical trials will be excluded. This national multicentre retrospective observational study will utilise the UKCHART research network, with 20 participating tertiary and district general hospitals. Variation in delivery pathways, toxicity management strategies, and supportive-care practices, together with changes in NHS immunoglobulin replacement policy, has created a natural experiment in elranatamab implementation. Approximately 400 patients are anticipated. There will be two retrospective data collection sweeps. The first will capture baseline characteristics, treatment history, delivery pathways, toxicity management, infection prevention strategies, healthcare resource utilisation, and early outcomes. The second, conducted around 12 months later, will provide longer-term follow-up including infection outcomes, immunoglobulin replacement utilisation, treatment patterns, subsequent therapies, and cumulative resource utilisation. Analyses will evaluate delivery models, CRS/ICANS management strategies, serious infections requiring hospitalisation, intensive care admission or death, immunoglobulin replacement utilisation, hospital admissions, bed-day utilisation, and variation across healthcare settings and socioeconomic groups. This study will generate one of the largest national real-world datasets on elranatamab implementation. Findings will inform optimisation of monitoring strategies and supportive-care delivery including infection prevention, to guide evidence-based NHS delivery models for elranatamab and other T-cell redirecting therapies.

Conditions

Myeloma Multiple

Outcome Measures

Primary Outcomes (2)

• Incidence of early severe treatment-related toxicity during step-up dosing

  Incidence of early severe treatment-related toxicity during step-up dosing, defined as: * Grade ≥3 CRS and/or ICANS, and/or * Unplanned hospital admission during step-up phase

  Time Period between 2024-2028

• Incidence of serious infection during treatment

  Incidence of serious infection during treatment, defined as: • Infection requiring hospital admission, ICU admission, or resulting in death

  Time Period between 2024-2028

Secondary Outcomes (15)

• Supportive care and infection-related management

  Time Period between 2024-2028

• Subgroup and implementation variation analyses

  Time Period between 2024-2028

• Disease response and survival outcomes

  Time Period between 2024-2028

• Disease response and survival outcomes

  Time Period between 2024-2028

• Disease response and survival outcomes

  Time Period between 2024-2028

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our targeted study population will be relapsed/refractory multiple myeloma patients

You may qualify if:

• Age ≥18 years.
• Received elranatamab as a BCMA-directed therapy through an NHS-supported funded access pathway (including early access programmes and routine NHS commissioning) between 1 January 2024 and 31 December 2026.

You may not qualify if:

• Receipt of elranatamab as part of an interventional clinical trial.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• Pfizer: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10