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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)
Primary Objective
To compare the overall survival between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression.
Secondary Objectives
To compare the progression-free survival between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) or indefinite maintenance therapy until disease progression.
To compare the progression-free survival between VRd and CRd induction followed by lenalidomide maintenance in patients with newly diagnosed symptomatic multiple myeloma.
To compare induction rates of response between VRd and CRd arms.
To evaluate the time to progression, duration of response and overall survival between VRd and CRd induction therapy.
To compare induction rates of toxicity between VRd and CRd arms.
To evaluate toxicity during lenalidomide maintenance.
Quality of Life Objectives
To compare the short and long-term health-related quality of life impact between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression.
To compare the impact on health-related quality of life between VRd and CRd induction therapy.
To evaluate the association between early induction response and change in health-related quality of life.
To describe changes in health-related quality of life during the induction, active maintenance and observation phases.
To evaluate correlation between treatment adherence during maintenance and health-related quality of life.
Laboratory Research Study Objectives
To compare induction minimal residual disease negativity rates between VRd and CRd arms.
To compare minimal residual disease negativity rates between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression.
To describe changes in minimal residual disease during the induction, active maintenance and observation phases and explore association with response.
To describe the mutational profile of newly diagnosed multiple myeloma.
To identify mutations associated with resistance to VRd and CRd regimens.
To identify expression profiles associated with MRD negativity with each of the regimens.
To determine the ability of MRD status at induction end to predict short-term and long-term overall and progression-free survival.
Primary Objective
To compare the overall survival between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression.
Secondary Objectives
To compare the progression-free survival between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) or indefinite maintenance therapy until disease progression.
To compare the progression-free survival between VRd and CRd induction followed by lenalidomide maintenance in patients with newly diagnosed symptomatic multiple myeloma.
To compare induction rates of response between VRd and CRd arms.
To evaluate the time to progression, duration of response and overall survival between VRd and CRd induction therapy.
To compare induction rates of toxicity between VRd and CRd arms.
To evaluate toxicity during lenalidomide maintenance.
Quality of Life Objectives
To compare the short and long-term health-related quality of life impact between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression.
To compare the impact on health-related quality of life between VRd and CRd induction therapy.
To evaluate the association between early induction response and change in health-related quality of life.
To describe changes in health-related quality of life during the induction, active maintenance and observation phases.
To evaluate correlation between treatment adherence during maintenance and health-related quality of life.
Laboratory Research Study Objectives
To compare induction minimal residual disease negativity rates between VRd and CRd arms.
To compare minimal residual disease negativity rates between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression.
To describe changes in minimal residual disease during the induction, active maintenance and observation phases and explore association with response.
To describe the mutational profile of newly diagnosed multiple myeloma.
To identify mutations associated with resistance to VRd and CRd regimens.
To identify expression profiles associated with MRD negativity with each of the regimens.
To determine the ability of MRD status at induction end to predict short-term and long-term overall and progression-free survival.
Recruitment Status
Past Studies