Study on Daratumumab for Treating Transplant-Eligible Patients with Multiple Myeloma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03477539

Provider View

This clinical trial is exploring how well the drug daratumumab works in patients with multiple myeloma who are eligible for a stem cell transplant. Daratumumab is a type of antibody that may help stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

The purpose of this study is to see if daratumumab can help patients with multiple myeloma achieve a state where minimal cancer cells are left after a stem cell transplant. The study will also look at how well patients do over time with this treatment, including their survival without the disease getting worse and overall survival rates. The safety of using daratumumab with another drug, lenalidomide, will also be assessed.

Description

In this study, patients will receive daratumumab in two phases before and after a stem cell transplant.

Consolidation Phase I: Patients will get daratumumab through an IV on specific days over four cycles, each lasting 28 days, unless the disease progresses or side effects become too severe.

Consolidation Phase II: About 8 weeks after finishing the first phase, patients will undergo a stem cell transplant.

Maintenance Phase: After the transplant, patients will continue to receive daratumumab and start taking lenalidomide pills. This phase lasts for up to 12 cycles, with each cycle being 28 days, as long as the disease does not progress or side effects are manageable. If patients continue to respond well, they may receive daratumumab every three months.

After completing the study treatment, patients will have follow-up visits at 30 days and then every 3-6 months for up to 3 years.

Eligibility Criteria

Inclusion Criteria

  • Eligible for a stem cell transplant.
  • Diagnosed with multiple myeloma and have received prior treatment.
  • Have measurable minimal residual disease (MRD) in the bone marrow.
  • Good overall health with an ECOG performance status of 0, 1, or 2.
  • Adequate blood cell counts and organ function based on specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Provide informed consent to participate in the study.
  • Have measurable disease at specific times related to diagnosis or relapse.

Exclusion Criteria

  • Have had a previous stem cell transplant for multiple myeloma.
  • Have received daratumumab before.
  • Have non-secretory multiple myeloma or amyloidosis.
  • Have a significant active infection requiring IV antibiotics.
  • Have severe nerve damage or POEMS syndrome.
  • Have had another cancer, unless it was adequately treated and in remission.
  • Are pregnant or breastfeeding.
  • Are not willing to use contraception if of childbearing potential.
  • Have had major surgery recently.
  • Have had a stroke or severe heart issues recently.
  • Have HIV, hepatitis B, or hepatitis C.
  • Have severe lung disease or asthma.

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