Myeloma Clinical Trial
Official title:
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma
The goal of this clinical research study is to learn if carfilzomib and vorinostat combined with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of this combination.
Busulfan Test Dose:
Participant will receive a test dose of busulfan by vein over about 60 minutes. This
low-level test dose of busulfan is to check how the level of busulfan in participant's blood
changes over time. This information will be used to decide the next dose needed to reach the
target blood level that matches participant's body size. Participant will most likely
receive this as an outpatient during the week before they are admitted to the hospital. If
it cannot be given to participant as an outpatient, they will be admitted to the hospital on
Day -11 (11 days before participant's stem cells are returned to their body) and the test
dose will be given on Day -10.
About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic
(PK) testing of busulfan. PK testing measures the amount of study drug in the body at
different time points and will help the study doctor decide what participant's dose of
busulfan in this study should be. These blood samples will be drawn at various timepoints
before participant receives busulfan and over about the next 11 hours. The blood samples
will be repeated again on the first day of high-dose busulfan treatment (Day -8). A
temporary heparin lock line will be placed in participant's vein to lower the number of
needle sticks needed for these draws. If it is not possible for the PK tests to be performed
for technical or scheduling reasons, participant will receive the standard fixed dose of
busulfan.
If participant receives the busulfan test dose as an outpatient:
On Days -12, -11, and -10, participant will receive palifermin by vein over about 30 seconds
each day to help decrease the risk of side effects in the mouth and throat.
Participant will be admitted to the hospital on Day -9.
If participant receives the busulfan test dose as an inpatient:
On Days -14, -13, and -12, participant will receive palifermin by vein over about 30 seconds
each day to help decrease the risk of side effects in the mouth and throat.
Participant will be admitted to the hospital on Day -11.
Study Drug Administration (for all participants):
With stem cell transplants, the days before participant receives their stem cells are called
minus days. The day participant receives the stem cells is called Day 0. The days after
participant receives their stem cells are called plus days.
Beginning on Day -9, participant will swish the liquids caphosol and glutamine in their
mouth 4 times a day, for about 2 minutes each time. Participant will swish these liquids
every day until they leave the hospital. These drugs are used to help decrease the risk of
side effects in the mouth and throat.
On Day -9 through Day -2, participant will receive dexamethasone 2 times a day by vein over
about 10 minutes.
On Day -8 through Day -2, participant will take vorinostat by mouth, with food.
On Day -8, participant will receive gemcitabine by vein over about 4 hours.
On Days -8, -7, -6, and -5, participant will receive busulfan by vein over about 3 hours.
On Days -7 and -6, participant will receive carfilzomib by vein over about 2-10 minutes.
On Day -3, participant will receive gemcitabine by vein over about 4 hours and melphalan by
vein over 30 minutes.
On Day -2, participant will receive carfilzomib by vein over about 2-10 minutes and
melphalan by vein over about 30 minutes.
On Day -1, participant will receive carfilzomib by vein over about 2-10 minutes.
On Day 0, participant will receive their stem cells by vein over about 30-60 minutes.
Participant will receive 3 more doses of palifermin by vein over about 15-30 seconds on Days
0, +1 and +2.
As part of standard care, participant will receive G-CSF (filgrastim) as an injection just
under their skin 1 time a day starting on Day +5 until their blood cell levels return to
normal.
Study Tests:
About 1 month, 100 days, 6 months, 1 year, and then about every 3-6 months for at least 2
years after the transplant:
- Participant will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests, to learn how the
transplant has taken, and to check the status of the disease.
About 100 days after the transplant, participant will have a bone marrow biopsy and
aspiration to check the status of the disease. To collect a bone marrow biopsy and aspirate,
an area of the hip or other site is numbed with anesthetic, and a small amount of bone and
bone marrow is withdrawn through a large needle. This will be repeated once a year or
earlier, if participant's doctor thinks it is needed.
Once a year, participant will have x-rays of all the bones in their body to check the status
of the disease.
The study staff will also stay in contact with participant's local doctor to find out if the
disease comes back and to check how they are doing.
Length of Treatment:
As part of standard care, participant will remain in the hospital for about 3-4 weeks after
the transplant. After participant is released from the hospital, they will continue as an
outpatient in the Houston area to be monitored for infections and transplant-related
complications.
Participant will be taken off study about 2 years after the transplant. Participant may be
taken off study early if the disease gets worse, if intolerable side effects occur, or if
they are unable to follow study directions.
If for any reason participant wants to leave the study early, they must talk to the study
doctor. It may be life-threatening to leave the study after participant has started to
receive the study drugs but before they receive the stem cell transplant because their blood
cell counts will be dangerously low.
This is an investigational study. Carfilzomib and melphalan are FDA approved for the
treatment of MM. Vorinostat is FDA approved for the treatment of cutaneous lymphoma.
Busulfan is FDA approved for the treatment of leukemia. Gemcitabine is FDA approved for the
treatment of lymphoma, breast cancer, and lung cancer. The use of these study drugs in
combination is investigational. The study doctor can explain how the study drugs are
designed to work.
Up to 75 participants will take part in this study. All will be enrolled at MD Anderson.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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