A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia


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Primary Outcome Measures:

  • Overall Response Rate [ Time Frame: 2 years ]

    Overall Response Rate= Minor response (>25%-50% reduction in serum IgM from baseline) + Partial Response (>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).

Secondary Outcome Measures:

  • Progression Free Survival [ Time Frame: 2 years ]

    Amount of time following daratumumab administration until >25% increase in serum IgM

  • Complete Response Rate [ Time Frame: 2 years ]

    A complete response is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.

  • Partial response Rate [ Time Frame: 2 years ]

    Partial response (PR) is defined as achieving a ≥50% reduction in serum IgM levels.

  • To evaluate the safety profile of daratumumab [ Time Frame: 2 years ]

    Percent of patients who experience adverse events related to daratumumab

  • Very Good Partial Response Rate [ Time Frame: 2 years ]

    Very Good Partial Response (VGPR): is defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels.

  • Minor Response Rate [ Time Frame: 2 years ]

    Minor Response (MR): A minor response (MR) is defined 25-49% reduction in serum IgM levels.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. “Investigational” means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved Daratumumab for this specific disease but it has been approved for other uses.

Daratumumab is a monoclonal human antibody. An antibody recognizes a specific protein and binds to it. Daratumumab binds to a protein called CD38 located on the surface of B cells like WM. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories.

In this research study, the investigators are evaluating the efficacy of Daratumumab as a single agent in participants with WM that has come back or has shown no response to previous treatment.