REal World MAIA UK OutcomEs
ConditionMyeloma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Royal Wolverhampton Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall response rate (OOR) at 12 months
Proportion with partial response (PR) or better (per IMWG criteria).
Time frame
12 months2
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
Time frame
12 monthsSecondary outcomes
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
Time frame
12 months and 24 months2
Overall survival at 12 and 24 months
Time from first dose to death from any cause
Time frame
12 months and 24 months3
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).
Time frame
24 months4
Occurrence of severe infections
% of patients who have had a grade 3 or 4 infection within 12 or 24 months of starting treatment
Time frame
12 months and 24 months from starting treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Royal Wolverhampton Hospitals NHS Trust
Lead sponsor
Johnson & Johnson
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: