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Protocol No. E1A11
Principal Investigator Callander, Natalie
Age Group Adult
Sponsor Type National
Title Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
Objective We want to find out if a drug combination of carfilzomib, lenalidomide and dexamethasone is a better treatment for multiple myeloma than a drug combination of bortezomib, lenalidomide and dexamethasone. Both lenalidomide and carfilzomib have been approved by the FDA (Food and Drug Administration) for treatment of multiple myeloma that has relapsed after other therapies, but are considered investigational for treatment of newly diagnosed myeloma. Bortezomib has been approved for treatment of both newly diagnosed myeloma as well as myeloma that has relapsed after other treatments.
Treatment This study involves giving you one of two combinations of drugs, blood and urine tests to check your health, physical exams, bone marrow tests, and answering questions about how you are feeling. Bortezomib is given as an injection either through the vein (intravenously, or IV) or under the skin (subcutaneously, or SC); carfilzomib is given IV; while lenalidomide and dexamethasone are both taken by mouth. You will be assigned which drug combination you will receive by chance. Neither you nor the study doctor will know which drug combination you will receive through the entire study.
Description This study has two parts, the first part is related to the initial treatment of myeloma (also called induction) and a second part is related to continued long term control of the myeloma (also called maintenance). The purpose of the first part of the study is to compare the effects, good and/or bad, of a combination of carfilzomib, lenalidomide and dexamethasone with another combination of bortezomib, lenalidomide and dexamethasone to find out which is better. In this study, you will get either the combination that contains carfilzomib or that containing bortezomib. You will not get both. Following the initial treatment of myeloma (induction), the second part of the study will examine if it is better to continue lenalidomide until the myeloma comes back or limit it for a defined period of 2 years. In this study, lenalidomide will be either stopped after 2 years or it will continue to be given until the myeloma relapses. Click here for more info
- Patients must be diagnosed with symptomatic standard-risk multiple myeloma /(SR-MM) within 90 days prior to registration
- Patients must have measurable or evaluable disease.
- Patients must have received no more than one cycle (4 weeks or less) of prior chemotherapy and no more than 160mg or prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. They should not have been exposed to lenalidomide, bortezomib or carfilzomib for treatment o symptomatic myeloma.
- Prior radiation therapy to symptomatic lesions is allowed provided 14 days have elapsed from the completion of radiation therapy.
- Age ≥ 18 years
- Patients must not have active, uncontrolled seizure disorder. Patients must have had no seizures in the last 6 months
- Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and do not require active therapy
- Pregnant or nursing women are excluded
- HIV infection is not excluded. Known HIV positive patients must meet the following criteria: CD4 cell count ≥ 350/mm3, no history of AIDS-related illness and not currently prescribed zidovudine or stavudine
- Patient enrolling to this study must agree to register to the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
Applicable Disease Sites Multiple Myeloma
Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park