Efficacy and Safety of Lenalidomide/Dexamethasone +/- Elotuzumab in MM

• Research type

  Research Study

• Full title

  A Phase 3, Randomised, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma

• IRAS ID

  76102

• Contact name

  Heather Oakervee

• Contact email

  heather.oakervee@bartsandthelondon.nhs.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2010-020347-12

• Clinicaltrials.gov Identifier

  NCT01239797

• Research summary

  Summary of Research

  Multiple myeloma is a malignancy of plasma cells and is one of the most frequent cancers of the bone marrow. Following initial treatment for myeloma, almost all patients will suffer relapse regardless of the therapy used. Hence, there is a significant unmet medical need for new treatments for multiple myeloma.The purpose of this study is to determine whether the addition of an investigational agent (elotuzumab) to standard therapy (lenalidomide and dexamethasone) is better than treatment with standard therapy 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 (dummy drug with no active ingredient). Both the patient and the study doctor will know which drugs are being used. 640 participants will take part in this study at about 190 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 primary objectives of this study were to compare the progression-free survival and objective response rate of elotuzumab plus lenalidomide/dexamethasone (E-Ld) versus lenalidomide/dexamethasone (Ld) in participants with Relapsed or Refractory Multiple Myeloma (RRMM). A key secondary objective was to compare the overall survival (OS)of participants taking E-Ld versus Ld.
  Approximately 640 participants were planned to be randomised to the two treatment groups in a 1:1 ratio.
  A total of 761 participants were enrolled at 168 sites in 21 countries. Of the 761 enrolled participants, 646 were randomised into the study, 321 in the E-Ld treatment group and 325 in the Ld treatment group.
  As of the 09-Aug-2021 all 635 treated participants were off treatment. The most common reasons for treatment discontinuation were disease progression, study drug toxicity, and adverse effects unrelated to study drug

  The OS figures showed a median OS of 48.30 months in the E-Ld treatment group vs 39.62 months in the Ld treatment group.
  As of the 09-Aug-2021 a total of 475 deaths (226 [70.4%] deaths in the E-Ld treatment group and 249 [76.6%] deaths in the Ld treatment group) had occurred. A total of 427 deaths were required for final analysis of OS.
  There were 210 (65.4%) of 321 participants treated with E-Ld and 229 (70.5%) of 325 participants treated with Ld that received subsequent systemic therapy. The most common subsequent therapies in both treatment groups were similar and included bortezomib (E-Ld 38.3%, Ld 43.4%); cyclophosphamide (E-Ld 31.2%, Ld 31.4%); and pomalidomide (E-Ld 26.2%, Ld 31.4%). The most common reason for receiving subsequent systemic therapy in both treatment groups was documented progression of disease (E-Ld 54.8%, Ld 56.9%).
  The safety profile of elotuzumab remains reflective of the known safety profile of elotuzumab in RRMM.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  11/EE/0291

• Date of REC Opinion

  29 Sep 2011

• REC opinion

  Further Information Favourable Opinion