Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone with Lenalidomide Alone After Stem-Cell Transplant for Multiple Myeloma

Sponsor: University of Chicago

Sponsor score: 0

ClinicalTrials ID:NCT02659293

This clinical trial is testing whether a combination of three drugs—Carfilzomib, Lenalidomide, and Dexamethasone—is more effective than Lenalidomide alone in patients who have undergone a stem-cell transplant for multiple myeloma.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of two treatment options for multiple myeloma patients who have completed a stem-cell transplant. One group will receive a combination of Carfilzomib, Lenalidomide, and Dexamethasone, while the other group will receive only Lenalidomide. The study aims to see which treatment helps patients live longer without the disease getting worse.

Description

The main goal of this study is to see if the combination of Carfilzomib, Lenalidomide, and Dexamethasone (referred to as KRd) helps patients live longer without their multiple myeloma progressing, compared to taking Lenalidomide alone. Researchers will also look at how well the treatments work in terms of reducing the amount of cancer in the body and achieving different levels of response, such as partial or complete remission.

Participants will be randomly assigned to one of the two treatment groups. The study will monitor the rate of minimal residual disease (MRD) negativity at 6 and 12 months, which indicates how much cancer is left in the body after treatment. The safety and side effects of the treatments will also be evaluated.

Eligibility Criteria

Inclusion Criteria

  • Completed a single autologous stem cell transplant after no more than two induction treatments (excluding dexamethasone alone) and have stable disease within 100 days post-transplant.
  • Started induction therapy within the last 12 months and had no more than two prior induction treatments.
  • Provide a bone marrow sample at the start of the study for MRD evaluation.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate liver function and specific blood counts within normal limits.
  • Have good kidney function.
  • Women of childbearing potential must have two negative pregnancy tests before starting Lenalidomide and agree to use two forms of birth control or abstain from sex during the study and for 28 days after.
  • Men must agree to use a condom during sex with women of childbearing potential while in the study and for 28 days after.
  • Agree to participate in the Revlimid REMS® program and follow its requirements.
  • Provide written informed consent to participate in the study.

Exclusion Criteria

  • Have had more than 12 months of prior therapy, unless considered on a case-by-case basis.
  • Experienced disease progression after initial therapy.
  • Have already started or received post-transplant maintenance or consolidation treatment.
  • Cannot tolerate Lenalidomide, Carfilzomib, or Dexamethasone.
  • Have certain other medical conditions, such as POEMS syndrome, plasma cell leukemia, or Waldenström's macroglobulinemia.
  • Have significant nerve damage or severe diarrhea.
  • Have cancer that has spread to the brain or spinal cord.
  • Are pregnant or breastfeeding.
  • Have had recent radiotherapy or major surgery.
  • Have had a heart attack or severe heart problems recently.
  • Have a history of blood clots or uncontrolled high blood pressure or diabetes.
  • Have an active infection or are HIV, hepatitis B, or hepatitis C positive.
  • Have had another type of cancer in the past three years, except for certain skin or prostate cancers.
  • Have any other medical condition that might interfere with the study or the ability to give informed consent.

Locations

FACILITYZIPCITYSTATE
University of Chicago60637ChicagoIllinois
Wayne State University - Karmanos Cacner Institute48201DetroitMichigan

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