Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn if the combination of elotuzumab and revlimid (also called lenalidomide) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (a transplant using participant's own stem cells). The safety of this drug combination will also be studied.


Study summary:

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, 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. On Days 8, 15, and 22 (+/- 3 days) of Cycles 1-2, blood (about 2 teaspoons) will be drawn for routine tests On Day 1 of all cycles and Day 15 of Cycles 3-6, blood (about 12 teaspoons total) will be drawn for immune system testing. 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


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) </=3 x ULN; Creatinine < 2.5 mg/dl; Recovered (i.e., </= Grade 1 toxicity) from the reversible effects of autologous stem cell transplant. 3. Patients whose primary therapy was changed due to suboptimal response or 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. 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 leat 24 months before the screening visit, OR; Are surgically sterile, OR; If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, 28 days prior to starting study drug, during study treatment and for 28 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized (i.e., status post vasectomy), who: Agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR; Agree to completely abstain from heterosexual intercourse. Exclusion Criteria: 1. Major surgery within 14 days before the first dose of study drug. 2. Radiotherapy within 14 days before enrollment. 3. Known active central nervous system involvement. 4. 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. 5. Female subject is pregnant or lactating. 6. Known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis. 7. Infection requiring systemic IV antibiotic therapy within 7 days before Cycle 1 Day 1 of therapy. 8. Known allergy to any of the study medications, their analogues, or excipients in the various formulations. 9. Failure to have fully recovered (i.e., </= Grade 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment. 10. Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment 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.


NCT ID:

NCT02420860


Primary Contact:

Principal Investigator
Sheeba K. Thomas, MD
M.D. Anderson Cancer Center

Sheeba K. Thomas, MD
Phone: 713-792-2860


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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