Official 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

Purpose

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

Detailed Description

Eligibility Criteria

Inclusion Criteria

STEP I: Hemoglobin >= 8 g/dL (obtained within 28 days prior to randomization)

STEP I: Untransfused platelet count >= 75,000 cells/mm^3 (obtained within 28 days prior to randomization)

STEP I: Absolute neutrophil count >= 1000 cells/mm^3 (obtained within 28 days prior to randomization)

STEP I: Calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior to randomization)

STEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization)

Exclusion Criteria

STEP I: Patients must not have active, uncontrolled seizure disorder

patients must have had no seizures in the last 6 months

STEP I: Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome

STEP I: Patients must not have grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) 4.0

STEP I: Patients must not have active, uncontrolled infection

STEP I: Patients should not have New York Heart Association classification III or IV heart failure or myocardial infarction within the previous 6 months

Keywords and/or Specific Medical Conditions

Allergy and Immunology

Hematology

Oncology (Adult)

Sponsors

ECOG-ACRIN Cancer Research Group