Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
Summary
This study is for patients that have multiple myeloma that has come back or relapsed and
their condition indicates a procedure called an Autologous Hematopoietic Stem Cell
Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are
removed before high-dose chemotherapy. Afterwards, the removed stem cells are put back into
the patient's body to form a new population of blood cells.
The high-dose chemotherapy administered before the AHSCT is called "Conditioning Therapy."
The FDA has approved the use of the drug melphalan as a conditioning therapy. This research
study will look at whether adding the study drug called carfilzomib will improve participant
outcomes. Carfilzomib is considered investigational and is not approved by the FDA for the
treatment of relapsed multiple myeloma.
This study is divided into two phases.
Phase I: Dose Escalation Phase:
The main purpose of Part I of this study is to examine the safety of the study drug,
carfilzomib, and determine the safest amount of the study drug that can be given to subjects
who have multiple myeloma. Subjects on this study will receive different dose levels of the
study drug. If you are one of the first three subjects to receive the study drug, it will be
at what is called the 'starting dose' for the study which is the lowest dose that is expected
to be tolerated based on prior research. After the first set of participants receive the
study drug, the study doctor will review their health to see how they are tolerating the
treatment. This will decide if the study drug dosage will be increased or decreased for the
next set of subjects who join the study. It is anticipated that 12- 18 participants will
enroll in the Phase I portion of this study.
Phase II: Safety Confirmation Phase:
Once the study doctor has discovered the highest possible dose of study drug that subjects
can tolerate, up to 28 more subjects may be enrolled at that dose level. The main purpose of
the Phase II portion of the study is look at how effective the combination of carfilzomib and
melphalan when given before your stem cell transplantation is in treating multiple myeloma.
This expansion phase will also include evaluation of two single agent carfilzomib maintenance
therapy regimens for patients without disease progression at day 100.