Combination Treatment Approaches for High-Risk Multiple Myeloma: REACH Trial

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05497804

Provider View

This phase II clinical trial is testing a combination of chemotherapy drugs to see if they can improve blood test results in patients with high-risk multiple myeloma. The study aims to find out if this drug combination can help patients who still have a small amount of cancer after initial treatment.

Patient Parameters

Program Overview

The purpose of this study is to test whether a combination of chemotherapy drugs—carfilzomib, daratumumab, lenalidomide, and dexamethasone—can improve outcomes for patients with high-risk multiple myeloma. These drugs work in different ways to stop cancer cells from growing, dividing, or spreading. The trial will help determine if patients with minimal residual disease, meaning a small amount of cancer left after initial treatment, will benefit from this drug combination.

Description

The main goal of this study is to see if the combination of chemotherapy drugs can lead to a sustained minimal residual disease (MRD) negative status, meaning no detectable cancer, in patients with high-risk multiple myeloma. This status should be maintained for at least one year.

Secondary goals include:

  • Understanding the side effects of this treatment.
  • Measuring the overall response rate, including very good partial response and complete response, at different stages of treatment.
  • Estimating how long patients live without the disease getting worse and their overall survival rate.

The study will also explore the genetic and environmental factors in the bone marrow before and after treatment.

Treatment Plan:

  • Induction Phase: Patients receive carfilzomib, lenalidomide, daratumumab, and dexamethasone in cycles over 12 months.
  • Consolidation Phase: Patients continue with carfilzomib, lenalidomide, and daratumumab for another 12 months.
  • Maintenance Phase: Patients receive carfilzomib, lenalidomide, and daratumumab for a final 12 months.

Patients will undergo various tests, including MRI, CT/PET scans, bone marrow biopsies, blood tests, and heart function tests throughout the study. After completing the treatment, patients will have follow-up visits every six months for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Age between 18 and 80 years.
  • Newly diagnosed with multiple myeloma.
  • Heart function with an ejection fraction of at least 40%.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Willing to provide informed consent and participate in follow-up visits.
  • Able to provide blood and bone marrow samples for research.
  • Life expectancy of more than 6 months.
  • Able to take daily aspirin or other blood thinners.
  • High-risk myeloma defined by specific criteria, such as certain genetic markers or blood test results.
  • Adequate kidney function and blood cell counts.
  • Registration within 30 days of pre-registration.
  • Insurance approval for all study drugs.

Exclusion Criteria

  • Conditions like monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma.
  • Recent diagnosis or treatment for another cancer, except for certain skin cancers.
  • Other health issues that could interfere with participation, like uncontrolled infections or heart disease.
  • Use of other chemotherapy or investigational treatments.
  • Severe nerve damage or recent major surgery.
  • Uncontrolled heart conditions or recent heart attack.
  • Positive for HIV or active hepatitis B or C infections.
  • Allergies or intolerances to study drugs.
  • Inability to follow study procedures.
  • Pregnant or nursing women, or those unwilling to use contraception.

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