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MyelomaREMAKENCT07532473

REal World MAIA UK OutcomEs

An observational study of Myeloma, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloma
How many people
300 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2026to Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tanweer Ahmed contact

01902 695065

rwh-tr.ukchart@nhs.net

Lorraine Jacques contact

rwh-tr.sponsorshipofresearch@nhs.net

United Kingdom1 site

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP

    Tanweer Ahmed, rwh-tr.ukchart@nhs.net

    Lorraine Jacques, rwh-tr.sponsorshipofresearch@nhs.net

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Myeloma
Medical subject headings
Neoplasms, Plasma Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (OOR) at 12 months

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

    Measured: 12 months

  2. 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

    Measured: 12 months

Secondary outcomes (7)

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

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

    Median time to disease progression or death

    Measured: 12 months and 24 months

  2. Overall survival at 12 and 24 months

    Time from first dose to death from any cause

    Measured: 12 months and 24 months

  3. Very good partial response (VGPR)

    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).

    Measured: 24 months

  4. Occurrence of severe infections

    % of patients who have had a grade 3 or 4 infection within 12 or 24 months of starting treatment

    Measured: 12 months and 24 months from starting treatment

  5. Treatment exposure /discontinuation (Treatment deliverability)

    Median duration of treatment

    % treatment discontinuation before 12 and 24 months

    Measured: 12 months and 24 months

  6. Dosing practice and outcome difference between academic and DGH trusts

    Measured: 12 months and 24 months

  7. Treatment setting

    Proportion of patients receiving daratumumab in the community via an outreach service

    Measured: 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07532473
Sponsor's protocol ID
2026HAE147
Acronym
REMAKE
Status last verified
Sep 2026
First submitted
7 Apr 2026
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myeloma, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tanweer Ahmed (01902 695065, rwh-tr.ukchart@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (OOR) at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07532473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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