Clinical Trials /

Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

NCT02420860

Description:

This phase II trial studies how well elotuzumab works when given with lenalidomide as maintenance therapy after transplant in patients with newly diagnosed multiple myeloma who underwent transplant using their own stem cells (autologous transplant). Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following the initial treatment. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Adding elotuzumab to standard maintenance therapy with lenalidomide may work better in treating patients with multiple myeloma who have undergone transplant.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Elotuzumab With Lenalidomide as Maintenance After Autologous Stem Cell Transplant (ASCT)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 2014-0729
  • SECONDARY ID: NCI-2015-00762
  • NCT ID: NCT02420860

Conditions

  • Myeloma

Interventions

DrugSynonymsArms
ElotuzumabElotuzumab + Lenalidomide
Dexamethasone acetateDecadronElotuzumab + Lenalidomide
DiphenhydramineBenadrylElotuzumab + Lenalidomide
FamotidinePepcidElotuzumab + Lenalidomide
LenalidomideCC-5013, RevlimidElotuzumab + Lenalidomide

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 MM from coming back after patients have had an autologous stem cell transplant. The safety of this drug combination will also be studied.

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, 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 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.

      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 100 participants will be enrolled in this study. All will take part at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
Elotuzumab + LenalidomideExperimentalElotuzumab dosed at 10 mg/kg by vein 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. Then for cycles beyond 6, once per cycle at 20 mg/kg on Day 1 of each cycle. Dexamethasone 28 mg by mouth between 3-24 hours prior to the start of Elotuzumab infusion or as a split dose 12-24 hours and 3 hours prior to Elotuzumab. Dexamethasone 8 mg by vein on day of Elotuzumab infusion prior to the start of infusion. Diphenhydramine 25-50 mg by mouth or vein prior to Elotuzumab. Famotidine 20mg by vein prior to Elotuzumab. Lenalidomide dosed at 10 mg/day; after three cycles, provided the ANC is >/= 1000/mL, platelet count >/= 100,000/mL and all non-hematologic toxicity is </= grade 1, dose may be increased to 15 mg/day at discretion of physician. Treatment with Lenalidomide and Elotuzumab use a cycle length of 28 days. Symptom questionnaire completion on Day 1.
  • Elotuzumab
  • Dexamethasone acetate
  • Diphenhydramine
  • Famotidine
  • Lenalidomide

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Every 6 months
Safety Issue:
Description:Primary endpoint is PFS defined as time from autologous stem cell transplantation (ASCT) to the time of clinical progression, death, whichever occurs first or the time of last contact. PFS monitored using the method of Thall et al. (Thall, 2005)

Secondary Outcome Measures

Measure:Toxicity of Elotuzumab with Lenalidomide
Time Frame:28 days
Safety Issue:
Description:Toxicity evaluation endpoint defined as treatment-related unmanageable toxicities, including grade 4 non-hematologic effects, or grade 4 hematologic effects that require termination of the treatment during cycle one. Toxicity rate of 30% or higher considered unacceptable.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Myeloma
  • Multiple myeloma
  • MM
  • Post autologous stem cell transplantation
  • ASCT
  • Elotuzumab
  • Lenalidomide
  • CC-5013
  • Revlimid
  • Dexamethasone
  • Decadron
  • Diphenhydramine
  • Benadryl
  • Ranitidine
  • Ranitidine hydrochloride
  • Zantac
  • Symptom questionnaire
  • Survey

Last Updated

January 17, 2017