NCT01842308

Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase 1/2 Trial of Carfilzomib and Melphalan and Conditioning for Autologous Stem Cell Transplantation for Multiple Myeloma (CARAMEL)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (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 carfilzomib when given together with melphalan and to see how well they work in treating patients with multiple myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of carfilzomib that can be added to high dose melphalan as part of conditioning chemotherapy for myeloma. (Phase I) II. To determine the efficacy of the combination 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 carfilzomib to high dose melphalan in patients with multiple myeloma (MM). II. To determine the progression free rate at 1 and 2 years post registration. 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 carfilzomib followed by a phase II study. CONDITIONING: Patients receive carfilzomib intravenously (IV) over 30 minutes on days -6, -5, -2, and -1. Patients also receive melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. After completion of study treatment, patients are followed up at day 30, day 100, and then every 90 days for up to 5 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
PROCEDURE	Autologous Bone Marrow Transplantation	Undergo autologous stem cell transplant
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo autologous stem cell transplant
DRUG	Carfilzomib	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Melphalan	Given IV

Timeline

• Start date: 2013-06-04
• Primary completion: 2017-10-11
• Completion: 2019-10-28
• First posted: 2013-04-29
• Last updated: 2020-09-01
• Results posted: 2020-09-01

Locations

2 sites across 1 country: United States