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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-003578
    • Scottsdale/Phoenix, Arizona: 18-003578
    • Jacksonville, Florida: 18-003578
    NCT ID: NCT03187262
    Sponsor Protocol Number: 17-164

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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).
  • Bone marrow at screening positive for CD38 expression by flow cytometry and/or immunohistochemistry.
  • 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 old.
  • ECOG performance status ≤2.
  • 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.Participants progressing on ibrutinib therapy (or other BTK inhibitor) may continue on therapy through screening, stopping at least 1 day prior to Cycle 1 Day 1.
  • 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.FCBP must be referred to a qualified provider of contraceptive methods if needed.FCBP must have a negative serum pregnancy test at screening.
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
  • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Ansell, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Stephen Ansell, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Stephen Ansell, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Study Progress

This study has completed enrollment of targeted participants and currently is completing research activities including study intervention, specimen collection, testing and data analysis.

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20429099

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