Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Plasma Cell Myeloma
- Transplant-Related Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 t...
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.
Tracking Information
- NCT #
- NCT02619682
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Leona Holmberg Fred Hutch/University of Washington Cancer Consortium