Know Cancer

or
forgot password

Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Myeloma

Thank you

Trial Information

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.


Inclusion Criteria:



1. Patient must have undergone autologous stem cell transplantation, with melphalan as a
preparative regimen, within 12 months of initiation of induction therapy for newly
diagnosed myeloma.

2. Time to initiation of maintenance therapy. Patients may start maintenance therapy as
early as 60 days post-transplant and up to 180 days post-transplant; as long as they
meet the following criteria: * Platelet count >/= 100,000/mm^3 * Neutrophil count >/=
1000/mm^4 * Total bilirubin aspartate aminotransferase (AST) (ie, < Grade 1 toxicity) from the reversible effects of autologous stem cell
transplant

3. Patients whose primary therapy was changed due to suboptimal response of toxicity
will be eligible, however no more than 2 regimens will be allowed prior to ASCT.

4. Male or female patients 18 years or older.

5. Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.

6. Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

7. Female patients who: Are postmenopausal for at least 1 year before the Screening
visit, OR Are surgically sterile, OR IF they are childbearing potential, agree to
practice 2 effective methods of contraception, at the same time, from the time of
signing the informed consent through 30 days after the last dose of study treatment,
OR agree to completely abstain from heterosexual intercourse. Male patients, even if
surgically sterilized (ie, status post vasectomy), who: Agree to practice effective
barrier contraception during the entire study treatment period and through 4 months
after the last dose of study treatment, OR Agree to completely abstain from
heterosexual intercourse.

Exclusion Criteria:

1. Patient has >/= Grade 2 peripheral neuropathy.

2. Major surgery within 14 days before the first dose of study drug.

3. Radiotherapy within 14 days before enrollment

4. Known active central nervous system involvement

5. Systemic treatment, within 14 days before study enrollment, with strong inhibitors of
CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A
(clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone,
posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin,
carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort

6. Inability to swallow oral medication, inability or unwillingness to comply with the
drug administration requirements, or GI procedure that could interfere with the oral
absorption or tolerance of treatment.

7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled
hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure,
unstable angina, or myocardial infarction within the past 6 months.

8. Female subject is pregnant or lactating.

9. Serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with participation or completion of treatment according to this
protocol.

10. QTc > 470 milliseconds (msec) on a 12-lead ECG obtained during the Screening period.
If a machine reading is above this value, the ECG should be reviewed by a qualified
reader and confirmed on a subsequent ECG.

11. Ongoing or active systemic infection, known human immunodeficiency virus (HIV)
positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus
hepatitis.

12. Infection requiring systemic antibiotic therapy or other serious infection within 14
days before study enrollment.

13. Known allergy to any of the study medications, their analogues, or excipients in the
various formulations.

14. Participation in clinical trials with other investigational agents not included in
this trial, within 21 days of the start of this trial and throughout the duration of
this trial.

15. Failure to have fully recovered (ie, chemotherapy regardless of the interval since last treatment.

16. Co-morbid systemic illnesses or other severe concurrent disease that, in the
judgement of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jatin J. Shah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0277

NCT ID:

NCT01718743

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Myeloma
  • Myeloma
  • Multiple Myeloma
  • MM
  • Post Autologous Stem Cell Transplant
  • Lenalidomide
  • CC-5013
  • Revlimid
  • MLN9708
  • Questionnaire
  • Survey
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030