At the time of abstract submission 20 patients were still on trial treatment and 22.5% of evaluable patients had received trial therapy for 12 months or longer.Īnaemia, fatigue and infection of any grade were common side effects and similar in frequency between treatment arms, whereas higher grade cytopenias were more frequent with CPd than Pd. PFS data is currently maturing and will be presented at the conference. Five patients (9.8%) on CPd treatment reached CR vs. Treatment with CPd was associated with a significantly higher response rate (≥PR) of 68.6% (95% CI: 54.1 - 80.9%) compared to 47.1% (CI: 32.9 - 61.5%) for Pd ( P=0.018). Trial entry criteria were permissive and allowed ongoing red cell, platelet and growth factor support to reflect real-world practice in RRMM - 11% of patients required platelet and 16% G-CSF support before starting trial therapy. Patients had received a median of 3 prior lines of therapy (range 2-8) all had been treated with proteasome inhibitors and lenalidomide and 94% of patients had received cyclophosphamide as part of earlier lines of therapy. In total 102 evaluable RRMM patients were randomised between March 2016 and February 2018, 51 each to CPd and Pd treatment arms that were comparable regarding age, gender, ISS and ECOG performance status. The original sample size was 250 patients but due to approval of pomalidomide by the UK funding agency NICE mid-recruitment, and resulting low enrolment rates, a decision was made to close the trial early. Patients underwent bone marrow sampling and peripheral blood collection at baseline, on treatment and at relapse to correlate outcomes with disease biology. The primary endpoint of the study is PFS, secondary endpoints include response, OS and safety and toxicity. Patients with ≥2 prior lines of therapy were randomised 1:1 to receive either CPd or Pd and treated until progression. MUKseven is a randomised phase II study for RRMM patients comparing cyclophosphamide (500 mg po d1, 8, 15), pomalidomide (4 mg days 1-21) and dexamethasone (40 mg if ≥75 years 20 mg d1, 8, 15, 21) (CPd) versus standard pomalidomide and dex (Pd). Data on the clinical value of cyclophosphamide and pomalidomide combination therapy in RRMM is currently sparse and lacking for patients that have previously been treated with cyclophosphamide in earlier lines of therapy. The combination of the classical alkylator cyclophosphamide with thalidomide (CTD) or lenalidomide (CRD) is standard of care in early lines of therapy in the UK and elsewhere. Treatment of relapsed/refractory myeloma (RRMM) remains a challenge as most approved and commonly accessible doublet treatments induce responses (≥PR) in less than half of patients.
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