Study of Elotuzumab With Lenalidomide as Maintenance After Autologous Stem Cell Transplant (ASCT)
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myeloma
Intervention: Elotuzumab (Drug); Dexamethasone acetate (Drug); Diphenhydramine (Drug); Ranitidine (Drug); Lenalidomide (Drug); Symptom Questionnaire (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Jatin J. Shah, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Overall contact:
Jatin J. Shah, MD, Phone: 713-792-2860
Summary
The goal of this clinical research study is to learn if the combination of elotuzumab and
revlimid (also called lenalidomide) can help to prevent MM from coming back after patients
have had an autologous stem cell transplant. The safety of this drug combination will also
be studied.
Clinical Details
Official title: Phase II Study of the Combination of Elotuzumab With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression Free Survival (PFS)
Secondary outcome: Toxicity of Elotuzumab with Lenalidomide
Detailed description:
Study Drug Administration:
If you are found to be eligible to take part in this study, you will start receiving the
study drugs after you have recovered from the stem cell transplant.
Each study cycle is 28 days.
You will receive elotuzumab by vein over about 2-4 hours on Days 1, 8, 15, and 21 for the
first 2 cycles, then on Days 1 and 15 only during Cycles 3-6, and then on Day 1 each cycle
after that.
You will also take lenalidomide capsules by mouth on Days 1-28. If the study doctor thinks
it is needed, your dose of lenalidomide may increase after 3 months.
If you miss a dose of lenalidomide, it should be taken as soon as possible on the same day.
If it is missed for the entire day, do not take another dose to make it up. If you take
more than 1 dose of lenalidomide in 24 hours, you should get emergency medical care and
contact the study staff right away.
You will keep a diary to record the drugs you take. You will be asked to bring the diary,
any unused drug, and empty drug containers to the clinic at each visit.
Before your dose of elotuzumab, you will be given standard drugs to help decrease the risk
of side effects. You may ask the study staff for information about how the drugs are given
and their risks.
Study Visits:
On Day 1 of all cycles(+/- 7 days):
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check the status of
the disease.
- You will complete a questionnaire that asks about symptoms you may be having. This
will take about 5-10 minutes to complete.
- Every 1 to 3 cycles, urine will be collected over 24 hours to check the status of the
disease. The study staff will give you a container and instructions on how to collect
the urine.
- If you can become pregnant, blood (about 1-2 teaspoons) will be drawn for a pregnancy
test.
On Day 1 (+/- 7 days) of every 1-3 cycles, blood (about 1-2 teaspoons each time) will be
drawn for mandatory research tests.
If the study doctor increases your dose of lenalidomide, on Days 8 and 15 of the cycle that
the dose is increased:
° Blood (about 2 teaspoons) will be drawn for routine tests.
If at any time during the study the doctor thinks the disease has come back, you will have a
bone marrow biopsy/aspirate to check the status of the disease.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation in the study will be over after you have completed the end-of-treatment
visit.
End-of-Treatment Visit:
About 30 days after the last dose of study drugs:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests and to check the status of
the disease.
- Urine will be collected over 24 hours to check the status of the disease.
- If the doctor thinks it is needed, you will have a bone marrow aspirate/biopsy to check
the status of the disease.
- If the doctor thinks it is needed, you will have a bone survey to check the status of
the disease.
- If you can become pregnant, blood (about 1-2 teaspoons) will be drawn for a pregnancy
test.
This is an investigational study. Lenalidomide is FDA-approved and commercially available
for the treatment of MM and myelodysplastic syndrome (MDS). Its use after an autologous
stem cell transplant is investigational. Elotuzumab is not FDA-approved or commercially
available. It is currently being used for research purposes only.
The study doctor can explain how the study drugs are designed to work.
Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients must have undergone autologous stem cell transplantation, within 18 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 210 days post-transplant; as long as they
meet the following criteria: Platelet count >/=100,000/mm^3; Neutrophil count
>/=1000/mm^3 (No growth factors within 5 days); Alanine aminotransferase (ALT) and
aspartate aminotransferase (AST)
Locations and Contacts
Jatin J. Shah, MD, Phone: 713-792-2860
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information
University of Texas MD Anderson Cancer Center Website
Starting date: April 2015
Last updated: August 20, 2015
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