Phase II Study of Daratumumab for Patients with High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT03236428

Provider View

This clinical trial is exploring the use of the drug Daratumumab to see if it can help prevent or delay the progression of Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Multiple Myeloma (SMM) into active multiple myeloma.

Patient Parameters

Program Overview

This study is testing Daratumumab, a drug that may help stop or slow down the progression of certain blood conditions into active multiple myeloma, a type of blood cancer. Daratumumab works by targeting a specific molecule on cancer cells, potentially killing them or stopping their growth. While it is approved for active multiple myeloma, it is not yet approved for MGUS or SMM. The study aims to find out if Daratumumab can effectively prevent these conditions from becoming more serious.

Description

This Phase II clinical trial is investigating whether Daratumumab can prevent or delay the progression of high-risk Monoclonal Gammopathy of Unknown Significance (MGUS) and low-risk Smoldering Multiple Myeloma (SMM) into active multiple myeloma. Multiple myeloma is a cancer affecting plasma cells, which are part of the immune system. Currently, there are no approved treatments for MGUS or SMM. Daratumumab is a monoclonal antibody that targets the CD38 molecule, which is found in high amounts on multiple myeloma cells. By attaching to CD38, Daratumumab may help kill or stop the growth of these cancer cells. Although the FDA has approved Daratumumab for active multiple myeloma, it is still being studied for its effectiveness in MGUS and SMM.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have high-risk MGUS or low-risk smoldering myeloma.
  • For high-risk MGUS: Less than 10% plasma cells, M-spike less than 3.0g/dL, and at least two of the following: abnormal free light-chain ratio, M-protein concentration of 1.5 g/dL or more, or non-IgG M protein.
  • For low-risk smoldering myeloma: Monoclonal protein of 3 g/dL or more, or 10% or more bone marrow plasma cells, or specific free light-chain ratio.
  • No evidence of active multiple myeloma symptoms like high calcium levels, kidney issues, anemia, or bone lesions.
  • Good overall health with specific blood counts and organ function.
  • Women must not be pregnant and must agree to use effective contraception if of childbearing potential.
  • Must be able to understand and sign an informed consent form.

Exclusion Criteria

  • Previous treatment for symptomatic multiple myeloma or smoldering multiple myeloma with certain drugs.
  • Currently receiving other cancer treatments or investigational therapies.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Recent diagnosis or treatment for another cancer, except for certain skin cancers or low-risk prostate cancer.
  • Severe lung conditions like COPD or uncontrolled asthma.
  • Uncontrolled illnesses like heart failure or infections.
  • Pregnant or breastfeeding women.
  • Allergic reactions to similar drugs as Daratumumab.
  • Active viral infections like HIV, hepatitis B, or hepatitis C.
  • Recent major surgery.
  • Unable to comply with study requirements due to conditions like alcoholism or psychological disorders.
  • Recent vaccination with live vaccines.
  • Significant heart disease or risk factors for heart problems.
  • Participation in other clinical trials within 30 days before this study.

Locations

FACILITYZIPCITYSTATE
Pacific Cancer Care93940MontereyCalifornia
Colorado Blood Cancer Institute80218DenverColorado
Massachusetts General Hospital02214BostonMassachusetts
Beth Israel Deaconess Medical Center02215BostonMassachusetts
Dana Farber Cancer Institute02215BostonMassachusetts
Karmanos Cancer Insitute48201DetroitMichigan

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