Clinical Trial TitlePhase II randomized trial of continuation of post-transplant maintenance with single-agent lenalidomide vs. consolidation/maintenance with ixazomib-lenalidomide-dexamethasone in patients with residual myeloma.
Clinical Trial Protocol Description:
The purpose of this study is to compare two maintenance strategies for patients with residual multiple myeloma after autologous bone marrow transplant: standard of care single agent lenalidomide versus investigational combination of lenalidomide, ixazomib and dexamethasone.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have completed induction treatment followed by autologous stem cell transplant as initial therapy for asymptomatic myeloma as per the following IMWG criteria and initiated revlimid maintenance:
- Have initiated lenalidomide maintenance at approximately 3 months post autologous stem transplant (preferably 70-90 but not more than 120 days).
- Are receiving lenalidomide 10mg or 15mg and be able to tolerate dose escalation to 25mg daily.
- Have received lenalidomide maintenance for 3 months (+1month window for maximum of 4 months lenalidomide prior to enrollment.
- Have no evidence of progressive disease on lenalidomide.
- Have any measureable residual disease at the time of screening for the study, documented in at least one of the following ways:
- SPEP/IFIX positive disease.
- Freelite only positive disease.
- SPEP/IFIX-negative and Freelite- negative but MRD – positive disease is allowed.
You will be excluded from the study if any of the following criteria apply to you:
- Have already started or received multi-drug consolidation regimen post-transplant except for lenalidomide maintenance.
- Have moderate diarrhea (> grade 1).
- Have known GI disease of GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
- Have severe neuropathy (> grade 3 peripheral neuropathy, or grade 2 with pain).
This is a partial list of inclusion and exclusion criteria.