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EAA171


Title EAA171: Optimizing Prolonged Treatment In Myeloma Using MRD Assessment (OPTIMUM)
Therapeutic Area Myeloma
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03941860?term=NCT03941860&draw=2&rank=1

Overview

The goal of this study is to determine whether escalating maintenance therapy with the addition of ixazomib to lenalidomide improves overall survival among patients who are minimal residual disease (MRD) positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (≤ 12 months from diagnosis).

This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.

This study involves pre-registration (Step 0) and randomization (Step 1). Bone marrow specimen must be submitted for central MRD assessment and results will determine step 1 eligibility. 

Study Details

Inclusion Criteria

1. Patient must be previously diagnosed with multiple myeloma and be on lenalidomide maintenance with ≥ 10mg daily dose for at least 10 months and no more than 15 months after an early autologous stem cell transplantation (SCT ≤ 12 months of diagnosis).
2. Patient must be able to undergo a diagnostic bone marrow aspirate following registration to Step 0 (Pre-registration).
3. Patient must not have primary refractory or progressive disease on a proteasome inhibitor-based regimen during induction therapy prior to stem cell transplant
 

Exclusion Criteria

1. Patient must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on protocol.
2. Patient must not be on other concurrent chemotherapy, or any ancillary therapy considered investigational.
3. Patient must not have another malignancy requiring treatment or have received treatment within 2 years before pre-registration or previously diagnosed with another malignancy and have any evidence of residual disease.
 

Study Requirements

Participants who decide to take part in this study, will either get lenalidomide and the study drug called ixazomib, or will get lenalidomide and a placebo, until their disease gets worse or the side effects become too severe. A placebo looks like the study drug, but contains no medication. Participants and their doctor will not know if the patient is getting the study drug or placebo.

After finishing study treatment, the doctor will continue to follow the participants’ condition for up to 15 years and watch for side effects as well as the participant’s overall health. The doctor will check on the participants every 3 months after treatment if they stop the study within the first 2 years, every 6 months after treatment if they stop the study between 2 and 5 years after starting, and every 12 months after treatment if they stop the study after more than 5 years.