Efficacy of Lenalidomide/Dexamethasone +/-Elotuzumab in untreated MM
Research type
Research Study
Full title
A Phase 3, Randomised Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma.
IRAS ID
81613
Contact name
Atul Mehta
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2010-022445-20
Clinicaltrials.gov Identifier
Research summary
Research Summary
Multiple myeloma is a malignancy of plasma cells (a type of immune cell found in the body) and is one of the most frequent cancers of the bone marrow. There still remains a significant unmet medical need for new treatments for multiple myeloma. The purpose of this study is to determine if elotuzumab given with lenalidomide and dexamethasone is more effective in the initial treatment of multiple myeloma compared with a treatment of lenalidomide and dexamethasone alone. This study will also measure how the body processes the study drug elotuzumab (pharmacokinetics) and will assess the safety of elotuzumab combined with standard therapy. Patients will be randomised to either elotuzumab with standard therapy or to standard therapy alone. This is an ??open label? study and there is no placebo. Both the patient and the study doctor will know which drugs are being used. 750 participants will take part in this study at about 205 study centres throughout North America, Europe, and Asia. The length of participation in the study is not known. Treatment will continue until the myeloma progresses, there are unacceptable side effects, or the doctor decides to withdraw the patient from the study.
Summary of Results
The CA204006 Final Clinical Study Report presented data for the primary endpoint of Progression-Free Survival (PFS) and the secondary endpoint of ORR (03-Dec-2019 DBL, with a minimum follow-up of 65.3 months). Study CA204006 did not meet its primary endpoint of demonstrating a statistically significant improvement in PFS (IRC, primary definition) for E-Ld compared to Ld in subjects with newly diagnosed MM who were ineligible for ASCT. The objective response rate (ORR) (as determined by IRC) was numerically similar between treatment arms (82.9% in the E-Ld arm and 79.4% in the Ld arm). Similar numerical OS trends were observed between E-Ld and Ld arms (median OS of 60.42 months versus 57.56 months for E-Ld and Ld arms, respectively). The overall safety profile of elotuzumab was manageable and consistent with the established safety profile of elotuzumab in combination with Ld.
The CA204006 study began in August 2011 and completed in September 2021, which included the period when the COVID-19 pandemic was occurring. Global COVID-19 was declared a public health emergency of international concern by the World Health Organization on 30-Jan-2020, which coincided with the CA204006 study. When the pandemic disruption occurred, the study was fully enrolled with most participants in follow-up after treatment completion. One subject experienced a Grade 2 COVID-19 infection adverse event (AE) where the study drug was interrupted for a 2-week period. One subject died with a COVID-19 infection specified as the reason for death. There was no impact on the study conduct or results.
The purpose of this closeout clinical study report (CSR) for completed study CA204006 is to provide final safety data based on the 04-Mar-2022 clinical database lock (DBL). All subjects have ended study participation. Last patient last visit occurred on 04-Sep-2021.
The safety profile of E-Ld observed in Study CA204006 was generally consistent with the known profile of elotuzumab in combination with immunomodulatory drugs (IMiDs). No new safety signals or toxicities were identified since the previous data cut.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
11/WM/0341
Date of REC Opinion
3 Jan 2012
REC opinion
Further Information Favourable Opinion