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:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
  • 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
  • SECONDARY ID: 2014-0729
  • NCT ID: NCT02420860

Conditions

  • Hematopoietic Cell Transplantation Recipient
  • Plasma Cell Myeloma

Interventions

DrugSynonymsArms
ElotuzumabBMS-901608, Empliciti, HuLuc-63, HuLuc63, PDL-063, PDL063Treatment (elotuzumab, lenalidomide)
LenalidomideCC-5013, CC5013, CDC 501, RevlimidTreatment (elotuzumab, lenalidomide)

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. Establish activity of elotuzumab and lenalidomide in the maintenance setting post
      autologous stem cell transplant (ASCT) in myeloma patients.

      II. Progression free survival (PFS).

      SECONDARY OBJECTIVES:

      I. Progression free survival 2. II. Overall survival. III. Determine incidence of secondary
      primary malignancy. IV. Evaluate the best response rate (stringent complete response
      [sCR]/very good partial response [VGPR]/partial response [PR]) based on International Myeloma
      Working Group (IMWG) criteria.

      V. Evaluate time to progression. VI. Evaluate time to next therapy. VII. Evaluate the
      tolerability and toxicity. VIII. Perform MD Anderson Symptom Inventory (MDASI)-Myeloma
      symptom evaluation.

      OUTLINE:

      Patients receive elotuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15, and 21 of
      courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide orally
      (PO) on days 1-28. Courses repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (elotuzumab, lenalidomide)ExperimentalPatients receive elotuzumab IV over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Elotuzumab
  • Lenalidomide

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have undergone autologous stem cell transplantation, within 18 months of
             initiation of induction therapy for newly diagnosed myeloma

          -  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

          -  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

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

          -  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

          -  Female patients who: are postmenopausal for at least 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:

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

          -  Radiotherapy within 14 days before enrollment

          -  Known active central nervous system involvement

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

          -  Female subject is pregnant or lactating

          -  Known active hepatitis B virus hepatitis, or known active hepatitis C virus

          -  Infection requiring systemic IV antibiotic therapy within 7 days before cycle 1 day 1
             of therapy

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

          -  Failure to have fully recovered (i.e., =< grade 1 toxicity) from the effects of prior
             chemotherapy regardless of the interval since last treatment

          -  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
Time Frame:The time from autologous stem cell transplantation to the time of clinical progression, death, whichever occurs first or the time of last contact, assessed up to 48 months
Safety Issue:
Description:Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be used to include multiple covariates in the time-to-event analysis.

Secondary Outcome Measures

Measure:Response rate
Time Frame:Up to 48 months
Safety Issue:
Description:Estimated along with 95% confidence intervals.
Measure:Incidence of new primary malignancy
Time Frame:Up to 48 months
Safety Issue:
Description:Estimated along with 95% confidence intervals.
Measure:Overall survival
Time Frame:Up to 48 months
Safety Issue:
Description:Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be used to include multiple covariates in the time-to-event analysis.
Measure:Incidence of toxicity
Time Frame:Up to 48 months
Safety Issue:
Description:Toxicity data will be summarized by frequency tables. Per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. The intensity (severity) of adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Last Updated

October 22, 2020