ECOG-ACRIN E1A11

Clinical Trial Title Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Trial Status Closed to Enrollment
Start Date 02/22/2017
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Multiple Myeloma
Description This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma
Eligibility Criteria
  • Age ≥ 18 years.
  • Must be diagnosed with symptomatic standard-risk multiple myeloma (SR-MM) within 90 days prior to registration.
  • Must have received no more than one cycle (4 weeks or less) of prior chemotherapy and no more than 160mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma.
  • ECOG performance status 0, 1, or 2. (PS 3 allowed if secondary to pain).
  • Must not have active, uncontrolled seizure disorder.
  • Must not have uncontrolled intercurrent illness.

  • Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible

*Note: HIV infection patients are eligible if meet the following criteria:

  • CD4 cell count ≥ 350/mm3
  • No history of AIDS-related illness
  • Not currently prescribed zidovudine or stavudine

 
IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT01863550
Principal Investigator Jacqueline Vuky, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org