- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03187262
A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
A Phase 2 Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Boston, Massachusetts, United States, 02214
- Massachusetts General Hospital
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Washington
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Seattle, Washington, United States, 98109
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daratumumab
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: 4 years
|
Amount of time following daratumumab administration until >25% increase in serum IgM
|
4 years
|
Number of Participants With Complete Response
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.
|
2 years
|
Number of Participants With Partial Response
Time Frame: 2 years
|
Partial response (PR) is defined as achieving a ≥50% reduction in serum IgM levels.
|
2 years
|
Number of Participants With Very Good Partial Response
Time Frame: 2 years
|
Very Good Partial Response (VGPR): is defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels.
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2 years
|
Number of Participants With Minor Response
Time Frame: 2 years
|
Minor Response (MR): A minor response (MR) is defined 25-49% reduction in serum IgM levels.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge J Castillo, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Waldenstrom Macroglobulinemia
- Antineoplastic Agents
- Daratumumab
Other Study ID Numbers
- 17-164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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