Study Comparing Two Treatment Combinations for Newly Diagnosed Multiple Myeloma

Sponsor: University of Chicago

Sponsor score: 0

ClinicalTrials ID:NCT03729804

This clinical trial is comparing two different combinations of medications to treat patients who have been newly diagnosed with multiple myeloma, a type of blood cancer. The study aims to determine which combination is more effective.

Patient Parameters

Program Overview

This study is designed to compare the effectiveness of two treatment combinations for patients with newly diagnosed multiple myeloma. The two combinations being tested are: Carfilzomib, Lenalidomide, and Dexamethasone (KRd) versus Bortezomib, Lenalidomide, and Dexamethasone (VRd). Multiple myeloma is a cancer that affects plasma cells in the bone marrow, and this study aims to find out which treatment combination works better for patients who have not yet received any treatment for their condition.

Eligibility Criteria

Inclusion Criteria

  • Must have been newly diagnosed with multiple myeloma and need treatment.
  • No previous chemotherapy for multiple myeloma, and limited prior steroid use is allowed.
  • Both patients who are candidates for a stem cell transplant and those who are not can participate, but transplant candidates must agree to delay the transplant.
  • Must have symptomatic multiple myeloma as per specific medical criteria.
  • Must have a certain level of cancer cells in the bone marrow or a biopsy-proven plasmacytoma.
  • Must have measurable disease based on specific protein levels in the blood or urine.
  • Must provide a bone marrow sample for study purposes.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still perform light work.
  • Must have adequate liver function and specific blood cell counts.
  • Must have good kidney function.
  • Women of childbearing potential must have two negative pregnancy tests before starting treatment and agree to use effective contraception.
  • Men must agree to use condoms during sexual activity and for a period after the study.
  • Must agree to participate in the Revlimid REMS® program and comply with its requirements.
  • Must agree to pregnancy prevention and counseling.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Patients who are frail and not candidates for a transplant.
  • Patients with certain types of multiple myeloma that do not produce enough protein to measure.
  • Patients with specific syndromes or other types of blood cancers.
  • Patients who have had recent extensive radiation or immunotherapy.
  • Patients who have participated in another investigational study recently.
  • Patients with progressive disease as per specific criteria.
  • Patients who cannot tolerate the study medications.
  • Patients with significant nerve damage or severe diarrhea.
  • Patients with central nervous system involvement.
  • Patients who cannot take blood clot prevention medication.
  • Patients with recent severe heart conditions or uncontrolled heart issues.
  • Pregnant or breastfeeding women.
  • Patients who have had major surgery recently.
  • Patients with recent heart attacks or severe heart failure.
  • Patients with a history of blood clots or severe lung conditions.
  • Patients with uncontrolled diabetes or infections.
  • Patients with active viral infections like HIV or hepatitis.
  • Patients with other cancers within the past three years, except for certain skin or prostate cancers.
  • Patients with any medical condition that might interfere with the study or their ability to consent.

Locations

FACILITYZIPCITYSTATE
University Of Chicago Medicine Comprehensive Cancer Center60637ChicagoIllinois

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