REal World MAIA UK OutcomEs

NCT07532473 | Not Yet Recruiting

• 1 other identifier: 2026HAE147
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study will describe the use of triplet therapy with daratumumab, lenalidomide and dexamethasone (DRd) in the treatment of for transplant ineligible (TIE) untreated myeloma outside of clinical trials and assess the associated clinical outcomes.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (2)

• Overall response rate (OOR) at 12 months

  Proportion with partial response (PR) or better (per IMWG criteria).

  12 months

• Real-world dosing strategy for DRd - starting doses of Daratumumab, Lenalidomide and dexamethasone in cycle 1 and relative dose intensity at 12 months

  % of patients who have had a dose adjustment in any of the DRD treatment components within the first 12 months of treatment

  12 months

Secondary Outcomes (7)

• Progression -Free Survival (PFS) at 12 and 24 months

  12 months and 24 months

• Overall survival at 12 and 24 months

  12 months and 24 months

• Very good partial response (VGPR)

  24 months

• Occurrence of severe infections

  12 months and 24 months from starting treatment

• Treatment exposure /discontinuation (Treatment deliverability)

  12 months and 24 months

Eligibility Criteria

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

Study Population

Sites participating in this study will be those who have prescribed DRd for newly diagnosed transplant ineligible patients since this triple combination was reimbursed for use in the UK healthcare system in 2023. Within the study, data will be collected from the medical records of adult patients aged ≥18 years with ND MM, who are ineligible for transplant and who have received at least one dose of DRd outside of clinical trials. To be eligible for inclusion in the study, the date of the first dose should be: * on or before 31 December 2024, between September 2023 to 31 December 2024 (first data cut) * on or before 31 December 2025, between September 2023 and 31 December 2025 (second data cut) Data will be analysed in Q1 2026 to assess treatment outcomes at 12 months (to 31 December 2025) and in Q1 2027 to assessment 12- and 24-months treatment outcomes.

You may qualify if:

• Age ≥18 years
• Diagnosis of NDMM
• Not eligible for autologous stem cell transplant at diagnosis
• Received frontline DRd treatment following NICE approval (post-September 2023)
• Minimum 3 months of follow-up data available

You may not qualify if:

• Participation in an interventional clinical trial for first-line therapy
• Insufficient treatment or follow-up data for analysis
• DRd used in relapsed/refractory setting rather than newly diagnosed disease

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• Johnson & Johnson: collaborator

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Hannah Giles

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanweer Ahmed

CONTACT

01902 695065; rwh-tr.ukchart@nhs.net

Lorraine Jacques

CONTACT

rwh-tr.sponsorshipofresearch@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

GB (1)