5439W-13: Millennium MM

CRC 13092: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

Type of Study
Cancer (Oncology) - Multiple Myeloma
Swedish Cancer Institute
Short Description
Purpose: This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of MLN9708 versus placebo when added to lenalidomide and dexamethasone (LenDex) in patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.
Open to Enrollment
Principal Investigator
Henry Kaplan, M.D.
Eligibility Notes
  • Male or female patients 18 years or older diagnosed with Multiple Myeloma according to standard criteria who have not received prior treatment
  • Patients for whom lenalidomide and dexamethasone treatment is appropriate and who are not eligible for high-dose therapy followed by stem-cell transplantation (HDT-SCT) for 1 or more of the following reasons:
    • the patient is 65 years of age or older
    • the patient is less than 65 years of age but has significant comorbid condition(s) that are, in the opinion of the investigator, likely to have a negative impact on tolerability of HDT-SCT
  • Eastern Cooperative Oncology Group (ECOG)performance status of 0 to 2
  • Must be able to take concurrent aspirin 70mg to 325 mg daily (or enoxiparin if aspirin allergic)
  • No prior treatment for multiple myeloma with either standard of care treatment or investigational regimen
  • No inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086