NCT03202628

Ixazomib Citrate, Pomalidomide, Dexamethasone, Stem Cell Transplant in Treating Relapsed or Refractory Multiple Myeloma

Phase 2 Trial of Induction With Ixazomib, Pomalidomide, Dexamethasone Prior to Salvage Autologous Stem Cell Transplant Followed by Consolidation With Ixazomib, Pomalidomide, and Dexamethasone and Ixazomib Maintenance in Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem cell transplantation works in treating patients with multiple myeloma that has come back or does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone, before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving ixazomib citrate in addition to pomalidomide, dexamethasone, and stem cell transplantation may work better in treating patients with relapsed or refractory multiple myeloma.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the rate of progression free survival at 18 months from study entry after therapy with ixazomib citrate (ixazomib \[MLN9708\]) in combination with pomalidomide and dexamethasone followed by a single autologous stem cell transplantation (ASCT) and consolidation with ixazomib in combination with pomalidomide and dexamethasone and maintenance with ixazomib in relapsed refractory ASCT naive multiple myeloma (MM) patients. SECONDARY OBJECTIVES: I. To determine the best overall response rates (\>= partial response \[PR\]) and deep responses (very good partial response \[VGPR\], complete response \[CR\], stringent complete response \[sCR\]) at various stages of treatment: after induction, after stem cell transplantation (SCT), after consolidation and during maintenance. II. To determine the overall survival from study entry. TERTIARY OBJECTIVES: I. Assessment of minimal residual disease (MRD) by flow cytometry at various stages of treatment: after induction, day # 100 after SCT, after consolidation and during maintenance at year 1 and 2 from initiation of maintenance therapy. II. To determine the engraftment kinetics (white blood cells \[WBC\] and platelet) following single salvage ASCT for relapsed disease. OUTLINE: INDUCTION (COURSES 1-4): Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, pomalidomide (PO) on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity. TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT. CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months until progressive disease, and then every 6 months for 3 years.

Conditions

• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo ASCT
DRUG	Dexamethasone	Given PO
DRUG	Ixazomib Citrate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Pomalidomide	Given PO

Timeline

• Start date: 2017-07-24
• Primary completion: 2021-04-13
• Completion: 2021-04-13
• First posted: 2017-06-28
• Last updated: 2023-09-21
• Results posted: 2022-05-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study