Researchers are launching a new clinical trial to define the underlying biology of sustained measurable residual disease (MRD) negativity in patients with newly diagnosed multiple myeloma (MM).
Ola Landgren, MD, of Sylvester Comprehensive Cancer Center at the University of Miam in Florida, and colleagues presented details of the ADVANCE trial at the 65th ASH Annual Meeting and Exposition.
According to the abstract, “the International Myeloma Foundation 2009 and DFCI randomized studies for newly diagnosed patients have shown that MRD negativity 10-6 translates into similar progression-free survival (PFS) and overall survival (OS) outcomes when comparing patients treated across treatment arms irrespective of receiving early transplant. Delayed transplant does not shorten OS.”
The ADVANCE trial (NCT04268498) will enroll 308 patients and randomly assign them to eight cycles of carfilzomib, lenalidomide, and dexamethasone with or without daratumumab. All patients will be encouraged to undergo stem cell collection after four to six cycles of therapy. Patients who remain MRD positive after eight cycles will be offered high-dose melphalan followed by delayed autologous stem cell transplant.
MRD negativity is the primary endpoint. Patients who are MRD negative will transition to maintenance lenalidomide and be monitored for MRD status annually. The researchers will also conduct long-term monitoring to assess progression-free survival, event-free survival, and overall survival.
ADVANCE is currently open for enrollment, with 57% of the planned number of patients already enrolled.
Dr. Landgren presented additional information on the feasibility of the trial at the meeting.
Reference
Landgren O, Maura F, Kazandjian D. ADVANCE multicenter clinical trial: MRD-driven therapy in newly diagnosed multiple myeloma patients. Abstract #3392. Presented at the 65th ASH Annual Meeting and Exposition; December 9–12, 2023; San Diego, California.
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