A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Condition: Waldenström Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Daratumumab
Intervention description: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Waldenström Macroglobulinemia

Summary:

      This research study is studying Daratumumab as a possible treatment for Waldenström
      Macroglobulinemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenström Macroglobulinemia (Owen et al. 2003), and
             meeting criteria for treatment using consensus panel criteria from the Second
             International Workshop on Waldenström macroglobulinemia (Kyle et al. 2003)

          -  At least one previous treatment for WM with either documented disease progression or
             no response (stable disease) to the most recent treatment regimen

          -  Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum
             IgM level of >2 times the upper limit of normal of each institution is required

          -  Participants with symptomatic hyperviscosity or serum IgM >5,000 mg/dL to undergo
             plasmapheresis prior to treatment initiation

          -  Age ≥18 years

          -  ECOG performance status ≤2 (see Appendix A)

          -  Participants must have preserved organ and marrow function as defined below:

               -  Absolute neutrophil count ≥ 1,000/mcL

               -  Platelets ≥ 50,000/mcL

               -  Hemoglobin ≥ 8 g/dL

               -  Total bilirubin ≤ 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration
                  by neoplastic disease

               -  AST/ALT ≤ 2.5 × institutional upper limit of normal

               -  EGFR ≥ 30 ml/min

          -  Not on any active therapy for other malignancies with the exception of topical
             therapies for basal cell or squamous cell cancers of the skin.

          -  Females of childbearing potential (FCBP) must agree to use two reliable forms of
             contraception simultaneously or have or will have complete abstinence from
             heterosexual intercourse during the following time periods related to this study: 1)
             while participating in the study; and 2) for at least 90 days after discontinuation
             from the study. Men must agree to use a latex condom during sexual contact with a FCBP
             even if they have had a successful vasectomy. FCBP must be referred to a qualified
             provider of contraceptive methods if needed. FCBP must have a negative serum pregnancy
             test at screening.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, uncontrolled intercurrent
             illness, or psychiatric illness/social condition that would prevent study
             participation.

          -  Concurrent use of any other anti-cancer agents or treatments or any other
             investigational agents.

          -  Any condition, including the presence of laboratory abnormalities, which places the
             participant at unacceptable risk if he/she were to participate in the study or
             confounds the ability to interpret data from the study.

          -  Known CNS lymphoma.

          -  New York Heart Association classification III or IV heart failure.

          -  Known history of Human Immunodeficiency Virus (HIV), active infection with Hepatitis B
             Virus (HBV), and/or Hepatitis C Virus (HCV).

          -  Lactating or pregnant women.

          -  Grade >2 toxicity (other than alopecia) continuing from prior anti-cancer therapy.

          -  History of non-compliance to medical regimens.