NCT01718743

Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well ixazomib citrate and lenalidomide after stem cell transplant work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving ixazomib citrate together with lenalidomide may be effective in treating multiple myeloma.

Detailed description

PRIMARY OBJECTIVES: I. Establish safety and efficacy of oral ixazomib citrate (MLN 9708) and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients. SECONDARY OBJECTIVES: I. Incidence of secondary primary malignancy. II. Evaluate the best response rate (stringent complete response \[sCR\]/near complete response \[nCR\]/very good partial response \[VGPR\]/partial response \[PR\]). III. Evaluate time to progression. IV. Evaluate time to next therapy. V. Evaluate the tolerability and toxicity. VI. Evaluate M. D. Anderson Symptom Inventory (MDASI)-myeloma symptom evaluation. OUTLINE: Beginning 60-180 days post-transplant, patients receive ixazomib citrate orally (PO) on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Hematopoietic Cell Transplantation Recipient
• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib Citrate	Given PO
DRUG	Lenalidomide	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2012-12-03
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2012-10-31
• Last updated: 2025-01-28
• Results posted: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study