Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT06931704
Brief Summary:
Lenalidomide is a standard of care for maintenance therapy after autologous stem cell transplantation in newly diagnosed myeloma patients. Recently, two large phase 3 randomized trials demonstrated a progression free survival benefit with daratumumab maintenance post autologous stem cell transplantation. Bispecific antibodies targeting B-Cell Maturation Antigen are approved for the treatment of relapsed refractory myeloma patients after 3 prior lines of therapy including proteasome inhibitor, immunomodulator IMiD and anti CD38 monoclonal antibody. In the cohort A of the MAGNETISMM-3 phase 2 study (n=123), elranatamab single-agent demonstrated strong efficacy with favorable safety profile in patients with advanced multiple myeloma (median of 5 prior lines, 96% of patients with triple class refractory disease). Lenalidomide has been shown to promote cytotoxic activity of CD3 bispecific antibodies. 7We propose a phase 2 randomized study comparing elranatamab plus lenalidomide versus daratumumab plus lenalidomide for 2 years as post-transplant maintenance in patients with newly diagnosed multiple myeloma. The primary objective is minimal residual disease rate after one year of maintenance. Secondary objectives include Progression-Free Survival, safety, quality of life, return to work and overall survival.
Detailed Description:
Post transplant maintenance with daratumumab and lenalidomide is now considered a standard of care in transplant eligible newly diagnosed myeloma patients. The T-cell engager elranatamab is approved for relapsed myeloma patients, and is currently evaluated in frontline therapy. The combination of bispecific antibody with lenalidomide demosntrated promising response rates with favorable safety profile.
The phase 2 randomized study ELMMA aims to compare the efficacy and safety of elranatamab plus lenalidomide verus daratumumab plus lenalidomide for 2 years as post-transplant maintenance in newly diagnosed myeloma patients.
Target population: n=176, newly diagnosed myeloma transplant eligible following 4-6 cycles of quadruplet induction and autologous stem cell transplantation.
Study:
NCT06931704
Study Brief:
Protocol Section:
NCT06931704