A Phase 1/2 Trial of Carfilzomib and Melphalan and Conditioning for Autologous Stem Cell Transplantation for Multiple Myeloma (CARAMEL)
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:
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD), defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (Phase I)
Up to day 30
Yes
Suzanne Hayman
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
MC1185
NCT01842308
June 2013
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Mayo Clinic - Florida | Jacksonville, Florida 32224 |