REal World MAIA UK OutcomEs (REMAKE)

April 15, 2026 updated by: The Royal Wolverhampton Hospitals NHS Trust

A Retrospective Study of Clinical Outcomes in Newly Diagnosed, Transplant Ineligible Multiple Myeloma Patients Treated With Daratumumab, Lenalidomide and Dexamethasone (DRd) Outside of Clinical Trials in the UK

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Triplet therapy with daratumumab, lenalidomide and dexamethasone (DRd) for transplant ineligible (TIE) untreated myeloma patients (MAIA) was reported in 2019. NICE approved this in September 2023 and since this time DRd has become the standard of care regimen for TIE patients with newly diagnosed multiple myeloma in the UK. Although there are reports of real world experience (RWE) of DRd efficacy in relapsed setting, there are no RWE reports of DRd efficacy and outcomes from the UK where it is used in the upfront setting and very limited data from Europe. Moreover, UK clinicians often adopt a pragmatic dose adjustment approach, particularly in the dosing of lenalidomide (escalation and de-escalation) with steroid tapering. As well as reducing short-term toxicities, this approach may lead to longer term benefits by reducing long-term steroid adverse effects such as steroid-induced diabetes, help ameliorate immune paresis and reduce infection risk.

However, there is very limited data on the efficacy and outcomes of this practice. In particular, there is no published RWE on the impact of pre-emptive dose modifications on tolerability and efficacy in frail patients, the cohort in which the highest treatment discontinuation rates were observed in the MAIA trial. It is also perceived that patients with comorbidities, which would have been excluded in MAIA cohort, are benefiting from this flexible approach in real world practice, especially people with chronic kidney disease and other comorbidities. A proportion of patients initially deemed fit for autologous stem cell transplantation (received D-VTD as induction) are also receiving DRd if they fail to receive a transplant. These patients were not represented in the MAIA study and the outcomes following de-escalation from D-VTD to DRd are unknown.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (OOR) at 12 months
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression -Free Survival (PFS) at 12 and 24 months
Time Frame: 12 months and 24 months

Time from first dose to documented disease progression or death (whichever first)

Median time to disease progression or death
12 months and 24 months
Overall survival at 12 and 24 months
Time Frame: 12 months and 24 months
Time from first dose to death from any cause
12 months and 24 months
Very good partial response (VGPR)
Time Frame: 24 months
Per IMWG response definitions (CR = negative immunofixation in serum & urine + <5% bone-marrow plasma cells; sCR adds normal free light-chain ratio and absence of clonal plasma cells).
24 months
Occurrence of severe infections
Time Frame: 12 months and 24 months from starting treatment
% of patients who have had a grade 3 or 4 infection within 12 or 24 months of starting treatment
12 months and 24 months from starting treatment
Treatment exposure /discontinuation (Treatment deliverability)
Time Frame: 12 months and 24 months

Median duration of treatment

% treatment discontinuation before 12 and 24 months
12 months and 24 months
Dosing practice and outcome difference between academic and DGH trusts
Time Frame: 12 months and 24 months
12 months and 24 months
Treatment setting
Time Frame: 12 months and 24 months
Proportion of patients receiving daratumumab in the community via an outreach service
12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: Hannah Giles, University Hospital Birmingham NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026HAE147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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