Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
25

Summary

Conditions
  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma
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. 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 i...

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.

Tracking Information

NCT #
NCT03202628
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Prashant Kapoor Mayo Clinic