Study on Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01816971

Provider View

This clinical trial is exploring how well a combination of drugs—carfilzomib, lenalidomide, and dexamethasone—works when given before and after a stem cell transplant in patients who have recently been diagnosed with multiple myeloma, a type of blood cancer.

Patient Parameters

Program Overview

The purpose of this study is to see if using the drugs carfilzomib, lenalidomide, and dexamethasone before and after a stem cell transplant can effectively treat patients with newly diagnosed multiple myeloma. Carfilzomib may help stop cancer cells from growing by blocking certain enzymes. Lenalidomide may boost the immune system to fight cancer, and dexamethasone may help kill cancer cells or stop them from dividing. The study aims to find out if this combination can kill more cancer cells when used around the time of a stem cell transplant.

Description

The study is divided into several phases:

Induction Therapy: Patients will receive dexamethasone, carfilzomib, and lenalidomide for four cycles, each lasting 28 days, unless the disease progresses or side effects become unacceptable.

Transplant: Patients will undergo a stem cell transplant using their own cells.

Consolidation Therapy: After the transplant, patients will receive the same combination of drugs for another four cycles of 28 days each.

Maintenance Therapy: Patients will continue with dexamethasone and lenalidomide, and carfilzomib will be given on specific days. This phase lasts for 10 cycles of 28 days each, unless the disease progresses or side effects become unacceptable.

After completing the study treatment, patients will have follow-up visits every three months for two years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with multiple myeloma that requires treatment.
  • Suitable and willing to undergo a stem cell transplant.
  • Have measurable disease based on specific medical tests.
  • Life expectancy of more than three months.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Meet specific blood test criteria for liver and kidney function.
  • Women of childbearing potential must agree to pregnancy testing and use effective contraception.
  • Men must agree to use condoms during sexual activity and not donate sperm.
  • Willing to comply with all study requirements, including medication and follow-up visits.

Exclusion Criteria

  • Have a type of multiple myeloma that does not produce enough protein to measure.
  • Have certain other medical conditions like POEMS syndrome or Waldenstrom's macroglobulinemia.
  • Have had recent major surgery or certain other treatments.
  • Pregnant or breastfeeding women.
  • Have severe heart problems or uncontrolled medical conditions.
  • Have active infections or certain viral infections like HIV or hepatitis.
  • Have had another type of cancer in the past three years, with some exceptions.
  • Have significant nerve damage or other medical conditions that could interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.