NCT02389517

Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells and may also prevent the growth of new blood vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer cells by interfering with proteins necessary for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide is more effective with or without ixazomib citrate and dexamethasone in treating residual multiple myeloma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the rate of minimal residual disease (MRD)-negative disease by multiparameter-flow cytometry at 12 months after randomization. SECONDARY OBJECTIVES: I. Evidence of response as demonstrated by the improvement of the depth of response by at least one category according to International Myeloma Working Group (IMWG) response criteria. II. Progression free survival (PFS). III. Overall survival (OS). IV. Duration of MRD-negative disease. V. Safety and tolerability of experimental arm (ixazomib citrate, lenalidomide, and low dose dexamethasone \[IRd\]) vs. control arm (lenalidomide \[Rd\]). TERTIARY OBJECTIVES: I. Determination of markers of response based on pre-treatment characteristics using methods described in correlative research. II. Evaluation of MRD by gene sequencing method using the Sequenta platform (LymphoSIGHT®) in parallel with multi-parameter flow cytometry (MFC). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO once daily (QD) on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only). ARM II: Patients receive lenalidomide PO as in Arm I. In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After the completion of treatment, patients are followed up at 30 days and then every 3 months for 2 years.

Conditions

• Plasma Cell Myeloma
• Residual Disease

Interventions

Type	Name	Description
DRUG	Ixazomib Citrate	Given PO
DRUG	Lenalidomide	Given PO
DRUG	Dexamethasone	Given PO

Timeline

• Start date: 2015-03-02
• Primary completion: 2021-02-01
• Completion: 2024-01-01
• First posted: 2015-03-17
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

1 site across 1 country: United States