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Elotuzumab-Based Therapy Plus Transplantation in Newly Diagnosed Myeloma: Phase III Trial Results

By: Victoria Kuhr, BA
Posted: Thursday, January 27, 2022

Hartmut Goldschmidt, MD, of University Hospital Heidelberg and National Center of Tumor Diseases, Germany, and colleagues found the addition of the monoclonal antibody elotuzumab to lenalidomide, bortezomib, and dexamethasone (RVd) induction/consolidation therapy and lenalidomide maintenance did not improve progression-free or overall survival. However, the study authors commented, further analyses are ongoing to identify potential subgroups that may benefit from such therapy. These findings from the phase III GMMG-HD6 trial were presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 486).

The study included 564 patients. The treatment consisted of four 21-day cycles of RVd (arms A1/A2) or elotuzumab plus RVd (arms B1/B2) induction therapy. High-dose melphalan and autologous blood stem cell transplantation (ASCT) were followed by two 21-day cycles of RVd or elotuzumab plus RVd consolidation and lenalidomide or elotuzumab/lenalidomide maintenance for 2 years (arms A1/B1 vs. A2/B2).

The evaluable intention-to-treat and safety populations consisted of 559 and 555 patients, respectively; the four treatment groups were divided as follows: A1: n = 139/137; A2: n = 141/138; B1: n = 137/138; B2: n = 142/142. At least one high-dose melphalan treatment and ASCT were given to 495 patients (88.6%), of whom 116 (20.8%) received tandem high-dose melphalan and ASCT. Consolidation and maintenance therapies were initiated in 469 (83.9%) and 454 (81.2%) patients, respectively.

The rates of very good partial response or better prior to the start of consolidation therapy were 78.9%, 78.2%, 81.5%, and 80.7% in arms A1, A2, B1, and B2, respectively (P = .95). With a median follow-up of 49.8 months, progression-free survival was not significantly different between the four treatment arms. Overall survival was similar in all treatment arms. At least one (serious) adverse event occurred in most patients in all treatment groups.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.


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