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NCT Number: NCT07532473

REal World MAIA UK OutcomEs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location contact

Hannah Giles

PRINCIPAL_INVESTIGATOR

Lorraine Jacques

CONTACT

[email protected]

Tanweer Ahmed

CONTACT

[email protected]

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall response rate (OOR) at 12 months

    Time frame: 12 months

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

  2. 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

Secondary outcomes

  1. 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

  2. Overall survival at 12 and 24 months

    Time frame: 12 months and 24 months

    Time from first dose to death from any cause

  3. 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).

  4. 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

  5. Treatment exposure /discontinuation (Treatment deliverability)

    Time frame: 12 months and 24 months

    Median duration of treatment

    % treatment discontinuation before 12 and 24 months

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

    Time frame: 12 months and 24 months

  7. Treatment setting

    Time frame: 12 months and 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lorraine Jacques

CONTACT

[email protected]

Tanweer Ahmed

CONTACT

[email protected]

01902 695065

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Collaborators

  • Johnson & Johnson

Registry information

Official study 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

Acronym: REMAKE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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