Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Plasma Cell Myeloma
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To determine whether escalating maintenance therapy with the addition of ixazomib citrate (ixazomib) to lenalidomide improves overall survival among patients who are MRD positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (=<...

PRIMARY OBJECTIVES: I. To determine whether escalating maintenance therapy with the addition of ixazomib citrate (ixazomib) to lenalidomide improves overall survival among patients who are MRD positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (=< 12 months from diagnosis). SECONDARY OBJECTIVES: I. To establish whether progression-free survival is superior with the addition of ixazomib to lenalidomide maintenance. II. To evaluate best response on treatment and compare response rates between arms. III. To evaluate the safety profile of ixazomib added to lenalidomide and compare toxicity rates between arms. EXPLORATORY CLINICAL OBJECTIVES: I. To measure treatment exposure and adherence. II. To estimate treatment duration, duration of response and time to progression. PATIENT-REPORTED OUTCOMES OBJECTIVES: I. To determine the extent and timing of neuropathy associated with the addition of ixazomib to lenalidomide maintenance on patient reported health-related quality of life outcomes. II. To assess the impact and timing of disease control with the addition of ixazomib to lenalidomide maintenance on patient reported health-related quality of life outcomes. III. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events [PRO-CTCAE]) longitudinally and compare responses with provider-reported adverse events. IV. To measure the likelihood of medication adherence and examine the relationship with treatment exposure. V. To assess correlation among patient reported outcome measures and association with clinical outcomes. VI. To tabulate PRO compliance and completion rates. IMAGING OBJECTIVES: I. To evaluate the association between baseline fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) and patient outcomes. II. To compare overall survival with the addition of ixazomib to lenalidomide among baseline FDG-PET/CT-positive and FDG-PET/CT-negative subgroups. III. To compare the change in quantitative FDG-PET/CT parameters over time with the addition of ixazomib to lenalidomide. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive lenalidomide PO QD on days 1-21 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months if < 2 years from study entry, every 6 months if 2-5 years from study entry, then every 12 months for up to 15 years from study entry.

Tracking Information

NCT #
NCT03941860
Collaborators
Not Provided
Investigators
Principal Investigator: Shaji K Kumar ECOG-ACRIN Cancer Research Group