NCT01936090

Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase I/II Bortezomib, Melphalan and Low Dose TBI Conditioning for Patients Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of bortezomib when given together with melphalan, and total-body irradiation before stem cell transplant and to see how well it works in treating patients with multiple myeloma. Giving chemotherapy and total-body irradiation before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells that were collected from the patient's blood or bone marrow are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and total-body irradiation.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of bortezomib that can be added to high dose melphalan and low dose total body irradiation as part of conditioning chemotherapy for myeloma. (Phase I) II. To determine the efficacy of the bortezomib added to high dose melphalan and low dose total-body irradiation (TBI) in patients with myeloma undergoing stem cell transplantation, as defined by achievement of complete response (CR). (Phase II) SECONDARY OBJECTIVES: I. To examine the toxicities associated with addition of bortezomib to high dose melphalan and TBI in patients with multiple myeloma (MM). II. To determine the progression free rate at 1 and 2 years. TERTIARY OBJECTIVES: I. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status. II. To assess the HevyLite assay prior to and during treatment. OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II study. CONDITIONING REGIMEN: Patients receive bortezomib intravenously (IV) on days -5 and -2, TBI twice daily (BID) on days -5 and -2, and melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous bone marrow or peripheral blood stem cell transplant on day 0. After completion of study treatment, patients are followed up at 100 days and then every 90 days for up to 3 years.

Conditions

• DS Stage I Plasma Cell Myeloma
• DS Stage II Plasma Cell Myeloma
• DS Stage III Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib	Given IV
RADIATION	Total-Body Irradiation	Undergo TBI
DRUG	Melphalan	Given IV
PROCEDURE	Autologous Bone Marrow Transplantation	Undergo autologous bone marrow transplant
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo autologous peripheral blood stem cell transplant
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo autologous peripheral blood stem cell transplant
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-02-02
• Completion: 2018-02-16
• First posted: 2013-09-05
• Last updated: 2018-05-24

Locations

1 site across 1 country: United States