KEY TAKEAWAYS
- The Myeloma XI trial study (NCT01554852) aimed at comprehensive genetic profiling to predict Len maintenance benefit in multiple myeloma patients after ASCT.
- Total of 556 patients from the Myeloma XI trial, who were genetically profiled for t(4;14), t(14;16), t(14;20), del(1p), gain(1q), and del(17p). The co-occurrence of risk markers was computed.
- The study concluded that comprehensive genetic profiling identifies patients who may benefit significantly from Len maintenance. It should be considered for newly diagnosed patients to support management discussions along their treatment pathway.
The accurate prediction of the effectiveness of lenalidomide (Len) maintenance after autologous stem cell transplant (ASCT) for individual patients remains a challenge. Researchers conducted a comprehensive molecular profiling analysis to forecast the results of patients enrolled in the National Cancer Research Institute’s Myeloma XI (MyXI) trial. Genetically profiled patients were randomized to Len maintenance or observation after ASCT for t(4;14), t(14;16), t(14;20), del(1p), gain(1q), and del(17p) and computed the co-occurrence of risk markers. The study calculated progression-free survival (PFS), subsequent progression (PFS2), and overall survival (OS) from maintenance randomization and compared the two groups using Cox proportional hazards regression.
Of the 556 patients analyzed, 51% had no risk markers, 32% had single-hit (1 risk marker), and 17% had double-hit multiple myeloma (MM) (≥2 risk markers). Patients with single-hit MM, specifically those with isolated del(1p), del(17p), and t(4;14), derived the most significant benefit from Len maintenance, with a ∼40-fold, 10-fold, and sevenfold reduced risk of progression or death (PFS), respectively, compared with observation. This benefit translated into improved PFS2 and OS for this group of patients, with a median PFS of 57.3 months for Len maintenance compared with 10.9 months for observation. Patients with isolated gain(1q) derived no benefit, and those with double-hit MM, regardless of risk lesions, experienced little help from Len maintenance. The study revealed that comprehensive genetic profiling could identify patients who may benefit significantly from Len maintenance. It should be considered for newly diagnosed patients to support management discussions along their treatment pathway.
Source: https://pubmed.ncbi.nlm.nih.gov/36564045/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01554852
Panopoulou A, Cairns DA, Holroyd A, Nichols I, Cray N, Pawlyn C, Cook G, Drayson M, Boyd K, Davies FE, Jenner M, Morgan GJ, Owen R, Houlston R, Jackson G, Kaiser MF. Optimizing the value of lenalidomide maintenance by comprehensive genetic profiling: an analysis of 556 patients in the Myeloma XI trial. Blood. 2023 Apr 6;141(14):1666-1674. doi 10.1182/blood.2022018339. PMID: 36564045; PMCID: PMC10113174.
