NCT02619682

Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Alternating the Administration of Ixazomib and Lenalidomide as Maintenance Therapy After Autologous Transplant for Treating Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the safety of alternating ixazomib citrate and lenalidomide as treatment to help keep cancer from coming back after stem cell transplant (maintenance therapy) in treating patients with multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stimulate the immune system to attack cancer cells. Giving ixazomib citrate and lenalidomide as maintenance therapy after transplant may prolong the length of time until the cancer returns.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the toxicity of the use of ixazomib (ixazomib citrate) and lenalidomide as maintenance therapy after autologous transplant. SECONDARY OBJECTIVES: I. Evaluate the ability to deliver the planned therapy. II. Assess initial response to therapy. III. Evaluate the median time to disease progression. IV. Assess overall survival. OUTLINE: Within 30-120 days after completion of autologous transplant, patients receive ixazomib citrate orally (PO) on days 1, 8 and 15 every 28 days for 2 courses, followed by lenalidomide PO once daily (QD) on days 1-28 for 2 courses. Treatment repeats, alternating after every 2 courses, for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.

Conditions

• Plasma Cell Myeloma
• Transplant-Related Carcinoma

Interventions

Type	Name	Description
DRUG	Ixazomib Citrate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenalidomide	Given PO

Timeline

• Start date: 2015-12-30
• Primary completion: 2022-06-01
• Completion: 2025-10-24
• First posted: 2015-12-02
• Last updated: 2026-01-08
• Results posted: 2022-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study