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Maintenance Study For Patients With Residual Myeloma Post-Transplant

Clinical Trial Title: 
Phase 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 ID: 
15071603
Clinical Trial Investigator Name: 
Agne Paner, MD
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:
    1. Have initiated lenalidomide maintenance at approximately 3 months post autologous stem transplant (preferably 70-90 but not more than 120 days).
    2. Are receiving lenalidomide 10mg or 15mg and be able to tolerate dose escalation to 25mg daily.
    3. 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:
    1. SPEP/IFIX positive disease.
    2. Freelite only positive disease.
    3. 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.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-4685
Contact Name: 
Christine Deskovich RN, BSN, OCN