Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Study Drug Administration:
If you are found to be eligible to take part in this study, after you have recovered from
your transplant, you will be start receiving maintenance therapy to try to keep the disease
from coming back after the transplant.
You will take MLN9708 by mouth on Days 1, 8, and 15 of each 28 day cycle. You should
swallow the capsule whole, with water, and should not break, chew, or open the capsule. It
should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.
If you miss a dose and the next scheduled dose is 72 hours or more away, you can take
MLN9708 to make up for the missed dose. A double dose should not be taken to make up for a
missed dose. If you vomit after taking a dose, you should not repeat the dose but should
resume dosing at the time of the next scheduled dose.
You will also take lenalidomide by mouth. The number of capsules you take will depend on
side effects you may have.
If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day.
If it is missed for the entire day, it should not be made up. If you take too much
lenalidomide you should seek emergency medical care and contact study staff right away.
You will keep a diary to record the drugs you take. You will be asked to bring any unused
drug and empty drug containers to the clinic at their next visit.
Study Tests:
On Day 1 of Cycle 1 (+/- 7 days):
- You will complete a questionnaire that asks you about symptoms you may be having. This
will take about 5-10 minutes to complete.
- Your medical history will be recorded and you will be asked about any new drugs you may
be taking.
- Your performance status will be recorded.
- You will have a physical exam, including measurement of your vital signs, height, and
weight.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- Blood (about 2 teaspoons) will be drawn and stored at a research blood bank at MD
Anderson for future research related to cancer.
On Days 8 and 15 of Cycle 1 (+/- 3 days):
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may be having.
On Day 1 of Cycles 2 and beyond:
- Blood (about 4 teaspoons) will be drawn for routine tests and to be stored at a
research blood bank for future research related to cancer.
- Your medical history will be recorded and you will be asked about any drugs you are
taking and any side effects you may be having.
- You will have a physical examination, including measurement of your height and weight.
- You will complete the questionnaire about side effects you may be having.
- Women who are able to have children must have a negative blood (about 1-2 teaspoons)
pregnancy test 24 hours before beginning treatment.
At least every other cycle, blood (about 2 teaspoons) and urine (over 24 hours) will be
collected to check the status of the disease.
During Maintenance Therapy, women who are able to have children will have urine or blood
pregnancy tests (about 1-2 teaspoons) every 4 weeks if you have regular periods (or every 2
weeks, if your periods are not regular). This blood (about 1-2 teaspoons) or urine
pregnancy test will be repeated 4 weeks after your last dose of study drug.
If at any time during the study the doctor thinks the disease has come back, you will have a
bone marrow biopsy/aspirate.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment
visit.
End of Treatment Visit:
About 30 days after the last dose of study drugs:
- Blood (about 4 teaspoons) and urine will be collected (over 24 hours) for routine
tests.
- You will complete a questionnaire that asks you about symptoms you may be having.
- You will be asked about any drugs you are taking and side effects you may be having.
- You will have a physical exam, including measurement of your vital signs, height, and
weight.
- Your performance status will be recorded.
- You will have a bone survey to check the status of the disease.
- You will have a bone marrow aspirate/biopsy to check the status of the disease.
- Blood (about 3 tablespoons) will be drawn for routine tests
- If you are able to become pregnant, you will have a blood (about 1-2 teaspoons)
pregnancy test.
Banking:
All blood and tissue left over from the procedures performed as part of this study will be
collected and stored in a research bank at MD Anderson for use in future research related to
cancer. In addition, some blood will be collected for banking.
Before your samples can be used for research, the people doing the research must get
specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a
committee made up of doctors, researchers, and members of the community. The IRB is
responsible for protecting the participants involved in research studies and making sure all
research is done in a safe and ethical manner. All research done at MD Anderson, including
research involving your samples from this bank, must first be approved by the IRB.
Your samples will be given a code number. No identifying information will be directly linked
to your samples. Only the researcher in charge of the bank will have access to the code
numbers and be able to link the samples to you. This is to allow medical data related to the
samples to be updated as needed. Other researchers using your samples will not be able to
link this data to you.
This is an investigational study. Lenalidomide is FDA approved and commercially available
for MM and myelodysplastic syndrome. Its use after an autologous stem cell transplant is
investigational. MLN9708 is not FDA approved or commercially available.
Up to 48 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS)
Progression free survival defined as time from autologous stem cell transplantation (ASCT) to time of clinical progression, death, whichever occurs first or the time of last contact.
6 months
Yes
Jatin J. Shah, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0277
NCT01718743
December 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |