Study on Elotuzumab and Lenalidomide After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02420860

Provider View

This clinical trial is testing how well the combination of elotuzumab and lenalidomide works as a maintenance treatment after a stem cell transplant in patients with newly diagnosed multiple myeloma. The goal is to see if this combination can help prevent the cancer from returning.

Patient Parameters

Program Overview

This study is exploring the effectiveness of using elotuzumab and lenalidomide together as a maintenance therapy after patients with newly diagnosed multiple myeloma have undergone a stem cell transplant using their own cells. Maintenance therapy is given to help keep cancer from coming back after it has been treated. Elotuzumab is an immunotherapy that may help the immune system attack cancer cells, while lenalidomide is a biological therapy that can stop cancer cells from growing. The study aims to find out if adding elotuzumab to the standard maintenance therapy with lenalidomide can improve treatment outcomes for these patients.

Description

The main goals of this study are to see how well the combination of elotuzumab and lenalidomide works in keeping multiple myeloma from progressing after a stem cell transplant and to measure how long patients live without the cancer getting worse. Researchers will also look at overall survival rates, the occurrence of any new cancers, and how well patients respond to the treatment. They will also evaluate how long it takes for the cancer to progress, the time until the next therapy is needed, and the side effects of the treatment.

Patients in the study will receive elotuzumab through an IV infusion over 2-4 hours on specific days during the first two treatment cycles and then once a month in later cycles. They will also take lenalidomide pills daily for 28 days in each cycle. Each treatment cycle lasts 28 days and will continue as long as the cancer does not progress and the side effects are manageable. After finishing the study treatment, patients will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Must have had a stem cell transplant using their own cells within 18 months of starting treatment for newly diagnosed multiple myeloma.
  • Can start maintenance therapy between 60 and 210 days after the transplant if they meet the following conditions:
    • Platelet count of at least 100,000/mm³.
    • Neutrophil count of at least 1000/mm³ without recent growth factor support.
    • Liver enzymes (ALT and AST) no more than 3 times the upper limit of normal.
    • Creatinine level less than 2.5 mg/dL.
    • Recovered from the effects of the transplant to a mild level (grade 1 toxicity or less).
  • Can have had up to two different treatments before the transplant if needed due to poor response or side effects.
  • Must have an ECOG performance status of 0 to 2, indicating they are fully active or have some limitations but are still able to care for themselves.
  • Must provide written informed consent to participate in the study.
  • Women must be postmenopausal, surgically sterile, or agree to use two effective methods of contraception or abstain from heterosexual intercourse. Men must agree to use barrier contraception or abstain from heterosexual intercourse during the study and for 28 days after the last dose.

Exclusion Criteria

  • Major surgery within 14 days before starting the study treatment.
  • Radiation therapy within 14 days before joining the study.
  • Active cancer involvement in the central nervous system.
  • Difficulty swallowing pills or any condition that affects the absorption of oral medication.
  • Pregnant or breastfeeding women.
  • Active hepatitis B or C infection.
  • Recent infection requiring IV antibiotics within 7 days before starting treatment.
  • Allergy to any study medications or their components.
  • Not fully recovered from previous chemotherapy side effects.
  • Other serious health conditions that could interfere with the study or the assessment of treatment safety and side effects.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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